To analyze the quantity and diversity in the consumption fruits and vegetables, as well as its relationship with the consumer’s purchase characteristics and food environment. Baseline study stemming from a controlled and randomized community trial investigating a sample representative of Primary Health Care services  of Belo Horizonte, state of Minas Gerais. The intake of fruits and vegetables was analyzed in servings/day, whereas diversity was assessed by the Food Frequency Questionnaire. Users were also questioned on the frequency, purchase location and availability of these foods at their households. To assess the consumer’s food environment, commercial establishments within a 1.6 km radius around the program unit sampled were audited. 3,414 adults and older adults (88.1% women) were investigated, as well as 336 commercial establishments, in 18 units of the Health Academy Program. The average consumption of fruits and vegetables was adequate [5.4 (SD = 2.1) servings/day] but monotonous, with average daily intake of two different types. In the establishments audited, a good diversity (77.7% and 85.0%) and variety (74.5% and 81.4%) of fruits and vegetables was observed, although with lower quality of vegetables (60.4%). After adjusting for sociodemographic variables, we identified that knowledge on food crops (p = 0.006), increased monthly availability of fruits at households (p < 0.001), and greater variety of fruits (p = 0.03) and quality of vegetables (p = 0.05) in commercial establishments could improve the quantitative intake of fruits and vegetables, whereas a greater variety of fruits (p = 0.008) would increase consumption diversity. The intake of fruits and vegetables was quantitatively adequate but monotonous, being influences by the consumer environment. Such results highlight the need for improving educational actions in health services and programs, in addition to acting on the consumer environment, aiming to promote and maintain the adequate and diversified consumption, as recommended by Brazilian guidelines for proper and healthy eating. An important step in that direction was the industrialization2 , including fruits and vegetables (F&V)4 . The inadequate intake of F&V is one of the ten central factors in the determination of the global burden of diseases and is characterized by the insufficient quantity or lack of variety, with consequent reduction of the food repertoire and low intake of nutrients5 .As a result of industrialization, the intake of fresh foods decreased6 . However, none of them evaluated the diversity of F&V consumed. In this context, even if the strategies aimed at expanding the access and intake of F&V are the priority of health policies around the world5 , they are limited to stimulating and assessing the intake according to recommendations (five servings/day). Overall, they do not consider the importance of diversity in food and little cover the role of food environment on food intake, especially in collective contexts such as health services11 and in developing countries.The inadequate intake of F&V is globally widespread and often investigated by studies and population surveys in several countries10 . Studies show that a greater variety and availability of food in the consumer’s environment can favor their intake14 . A review study conducted in the United States pointed out that the low availability of F&V was associated with a worse diet quality14 .Environment can favor both unhealthy as healthy behaviors due to its strong interference on purchasing decisions and choices of individualsGiven the above, this article aimed to analyze the quantity and diversity of F&V intake and their relations with the consumer’s acquisition characteristics and food environment.10 and Menezes et al.15This study analyzed the baseline (2013/2014) of a controlled and randomized community trial in a probabilistic and representative sample of the Health Academy Program (PAS) units of Belo Horizonte, state of Minas Gerais. The research included PAS users and the food environment in their surroundings. Other research details can be seen in Costa et al.17 . In the municipality investigated, the PAS offers oriented physical exercise practices and health promotion actions in partnership with the Nucleus of Support to Family Health (NASF)17 .The PAS was chosen as research scenario because this is a Primary Care point that aims to contribute to the construction of health-promoting environments. To do so, it has infrastructure, equipment and qualified staff for the guidance toward healthy ways of life, including the promotion of proper and healthy nutrition, and for food and nutritional security actionsThe study was conducted within the standards research by the Declaration of Helsinki and approved by the Research Ethics Committees of the Federal University of Minas Gerais (0537.0.0203.000-11) and the City Hall of Belo Horizonte (0537.0.0203.410-11A). In addition, the study was registered in the Brazilian Registry of Clinical Trials (RBR-9h7ckx), according to the criteria required by the International Committee of Medical Journal Editors (ICMJE) and the World Health Organization (WHO).10 were randomly assigned, representing the total with a confidence level of 95% and 1.4% error. After data collection, in order to verify the maintenance of sample representativeness, statistical analysis were carried out, comparing the sociodemographic data of all units (n = 50) with those of the sample (n = 18), with the same levels of confidence and error.In the sampling process, 42 of the 50 PAS units installed in the municipality were considered. Six units located in areas of low health vulnerability were excluded due to their reduced number in the municipality, and two others were excluded due to the intense performance of intervention studies. Thus, 18 (42.8%) units distributed through the nine regions of the municipality15 . Inclusion criteria were: being at least 20 years old and having regularly participated in PAS activities in the month prior to the beginning of data collection. Exclusion criteria were: being pregnant and having cognitive impairment that hindered questionnaire application. Data of participation in the activities were collected through the daily frequency record held by the service, whereas cognitive impairment was observed from the initial assessment of the user in their entrance into PAS and from the evaluation conducted by the research team17 .In the sampled units, all participants were invited to participate in the study . Of these, 3,414 (90.7%) were interviewed, and one accounted for 237 refusals (6.3%) and 112 exclusions (3.0%)buffer with 1,600-meter radius around each PAS unit sampled were investigated. Such distance was chosen because it is adequate for carrying out purchases without the need for motorized transportation. Data of establishments and free fairs were made available by the municipality and added to those found spontaneously in the territory of PAS units during the visits to registered establishments10 .To characterize the food environment, establishments that traded F&V and free fairs within a Data collection was conducted by Nutrition academics and health professionals semiannually trained for using instruments and performing interviews, under the guidance of the field supervisor and the main researcher. Data were subjected to consistency analysis before and after tabulation.19 and included sociodemographic and economic characteristics, health aspects, acquisition profile, nutritional status and intake of F&V.Information was obtained from individuals through a questionnaire submitted to pilot study and applied in person by trained interviewers. The questionnaire was built from national studies and previous experience of the research group19 , which investigated the frequency  and the number of servings consumed. To verify the diversity of consumption, the specific Questionnaire of Food Frequency (QFF) was applied regarding the last six months, including 14 fruits and 22 vegetables. Diversity was assessed by the daily intake of the F&V analyzed19 . To characterize the F&V acquisition profile, variables related to knowledge on the concept of food crop and the availability of F&V at home were used, in addition to the frequency and type of establishment chosen for the purchase of F&V15 .To register the intake of F&V, the Brief Evaluation Questionnaire on Fruit and Vegetable Consumption (QBrief-F&V) was used, validated for the study population20 .Sociodemographic and economic characteristics investigated were sex, age, education level (years), marital status  and occupation . Material goods within the residence and education level of the family head were used for the economic classification of participants into five classes, from A (the richest) to E (the poorest), as determined by the Brazilian Economic Classification CriterionHealth aspects were assessed by the self-reported medical diagnosis of diabetes, hypertension and dyslipidemia, as well as by health perception . In addition, information on the frequency (days) and duration (minutes) of physical exercise practice and on the user’s time of participation in PAS (difference between the dates of data collection and entry of the user in the program) were collected.21 . Weight was assessed by a single measuring in a digital scale of the brand Marte®, with a 180 kg capacity and 100 g precision. The height was also assessed by a single measuring in a portable single, Alturexata® brand, with capacity for 220 cm, adopting the techniques recommended by the Ministry of Health22 .For the assessment of nutritional status, the anthropometric measurements of weight and height were used, based on which the body mass index (BMI) was calculated, classified according to the criteria defined by WHO23 . The following characteristics of the consumer environment were verified for F&V: diversity, variety and quality. To this end, instruments developed and validated for the Brazilian context24 were used, which were adapted including the 10 most purchased types of fruits and vegetables in Belo Horizonte , according to the 2008–2009 Family Budgets Survey8 .Visits were made to convenience stores, municipal market, grocery stores of the private sector and subsidized by the city hall, local or neighborhood markets, supermarkets of large networks, hypermarkets, whole retail stores and bakeries24 .Diversity was assessed by the number of F&V available in the establishment, whereas variety was verified by the number of different types of a same species . Quality was classified as good or bad from a subjective evaluation, considering the presence of blemishes and bruises or the appearance of “rotten” or “too ripe”The intake of F&V was analyzed in quintiles of daily servings consumed and described in an aggregate manner according to the PAS units investigated. Characteristics of the food environment, in turn, were analyzed according to the PAS units.To verify the association between participants’ characteristics and quintiles of F&V continuous, the Chi-square statistical test of linear trend was used for categorical variables and analysis of variance (Anova) for continuous variables. The multilevel linear regression was used to assess whether the indicators of food acquisition profile  and consumer food environment  explained the variations in the quantitative (servings/day) and quality intake (daily diversity) of F&V. Such analysis allows one to consider the hierarchical structure of the data aggregation level, in addition to the insertion of individual and contextual variables. Thus, the individual consumption (daily servings and diversity) of F&V consisted of the two outcomes analyzed, with the participants (level 1) nested according to PAS units (level 2).In addition to the food acquisition profile at an individual level, sociodemographic variables were added for model adjustment. The construction of the model occurred in a hierarchical manner, first building the null model (with including solely of the random intercept), followed by the insertion of individual variables and, finally, environment variables. Final models showed the variables that presented higher association  with the outcomes F&V servings and diversity consumed, after adjusting for individual variables. It should be highlighted these are models with random intercept, which do not show this pattern for coefficients (of fixed effects).The intraclass correlation coefficient (ICC) was quantified to analyze the variability within and between territories, providing the ratio of total variability, which depends on the differences between territories. The percentage of proportional variation in variance (PVP) was calculated between the null and the final models, aiming to analyze the extent to which the covariates explained the variation in outcomes between territories.All variables were analyzed in the program Stata/SE version 14.0 , and the statistical significance was established in 5%.3,414 individuals were interviewed and 336 commercial establishments in the territories of 18 PAS units were audited. Most participants were women (88.1%) and middle-aged adults [56.7 (SD = 11.7) years old], with reported average consumption of 5.4 (SD = 2.1) servings of F&V of two different types per day   .Participants in the last quintile of F&V intake [8.5 (SD = 1.9) servings/day], in comparison with those in the first quintile [3.0 (SD = 0.6) servings/day], were older, with a higher proportion of retirees, carriers of some chronic disease and more physically active individuals. Women reported a high consumption of F&V, which decreased as the F&V quintiles increased, a situation opposite to that of men   .Individuals in the last quintile of F&V consumption reported eating greater diversity of these foods than those in the first quintile   . The maThe characteristics of the consumer’s food environment according to PAS units investigated are presented in 2 = 2.04, ICC = 0.011; model level 1: σ2 = 2.02, ICC = 0.009; model levels 1 and 2: σ2 = 2.01, ICC = 0.004), indicating the covariates inserted helped explaining the F&V intake. In line with this result, the PVP calculation showed the model covariates explained 34.7% of the variable quantitative consumption of F&V.In the multilevel analysis, after adjusting for sociodemographic variables, one could see that knowledge on crops and the increased monthly availability at home and frequency of fruit purchases could increase consumption (servings/day) of F&V   . RegardThe variables of food acquisition profile investigated were not associated with the diversity of F&V consumed; however, the variables of territory offer had a positive association with it. Covariates inserted in the model helped explaining 28.3% of variety of F&V consumption.Participants in this program of health promotion, part of the Brazilian primary care, reported an adequate consumption of F&V (daily average of five servings). However, when evaluating the consumption qualitatively, food monotony was observed, with an average of only two different types of F&V consumed per day. The F&V acquisition profile interfered in consumption, with emphasis on the knowledge on food crops and purchase frequency and home availability of fruits. The consumer’s food environment, in turn, proved to be important for both the quantitative (servings/day) as the qualitative intake (consumption diversity).7 . In England (2011/2012), 70% of adults and 59% of older people did not consume the recommended amount of F&V3 . In the United States, the average daily consumption of such foods is 2.7 servings per day4 . In Latin America, in countries such as Argentina (2013) and Chile (2009/2010), 5.0% and 84.3% of the population did not present adequate intake of F&V, respectively7 . Research conducted in Brazil (from 1987 to 2009) show decline in average quantities purchased25 and F&V consumption26 , estimating that less than 10.0% of the population presented adequate intake8 .Such amount was surprisingly superior to national and international values27 verified 75.3% inadequacy in the F&V consumption. Part of the difference in results can be attributed to the time of user participation in the health service; in this study, the average was 20 months. Participation in health promotion service, although focused on the practice of physical exercises, seems to increase the adoption of other healthy habits of living, such as healthy foods, in addition to increasing all knowledge regarding the foods crop16 .The intake found in this study was also higher than that identified in other study carried out in the PAS. When analyzing those entering a triennium (2008 to 2010) on PAS, Costa et al.5 .In this study, therefore, we observed the potential of the health promotion service in reversing the quantitative deterioration of the F&V consumption. Such result reveals as possible path for governments to promote positive changes in this respect. However, it also points out the challenge of food monotony and the imminent need for discussing it in the context of educational actions and recommendations, rescuing and clarifying the WHO message that appropriate consumption consists of the regular, diversified and quantitatively recommended intake of F&V28 . Insufficient food diversity can hinder the maintenance of healthy eating habits in the long term, resulting in the reduction of the population food repertoire and in less nutritional content of food.There are more than 200 types of fruits and vegetables within different cultures, which differ by caloric density, water content and diversity of micro-nutrients, resulting in benefits to health and protection against diseases29 .Low diversity in F&V intake can also be related to the lowest price, time and complexity required for food preparation, as well as an attempt to overcome obstacles such as the low quality of F&V. These issues become even more relevant when one considers that vulnerable areas were studied, areas with an average income that is below the Brazilian population10 . The food environment should support healthy choices, offering ample choices of accessible, varied and quality foods. This study reinforces such information by suggesting that variables of the consumer’s food environment  were important, in addition to matters related to F&V purchase. In agreement with the results, in a study performed in Brazil, the reports of women on food acquisition revealed the variety of F&V in the establishments had an impact on the purchase of healthy foods at the expense of ultra-processed food30 .A prior study on commercial establishments in the PAS territory of Belo Horizonte showed that, in some units, there was a limited access to establishments with proper F&V availability and variety28 . In addition, still little is known on the influence of consumer’s environment in eating, a situation which shows how the food is still studied without considering the complexity in which it is immersed.Our results emphasize the importance of promoting adequate, diverse and healthy food in primary health care, considering its potential to incentivize healthy ways of living. However, we must move beyond the quantitative adequacy and associated factors, studying also the diversity consumedIt is suggested that further studies are conducted to better understand the relationship between intake, monotony and food environment (supply and demand), aimed at addressing questions such as: does the restricted environment leads to food monotony or is food monotony (little diversified demand) the one that leads to the precarious food supply in the territory?9 . Nonetheless, the results show the importance of working in other research scenarios, as well as of understanding the actions provided in health services as possible paths to cope with the challenges faced by the sector. The difficulty in obtaining reliable measures of food consumption has been singled out as an important limiting factor in the literature19 , which was no different in this study. The evaluation of consumption from questions specific to F&V, associated with examples of foods, mainly vegetables, may also have influenced the data of quantities consumed. A data validation study showed good accuracy of the report of fruit consumption, but in need of adjustments for vegetable intake19 .These results, albeit unprecedented and relevant, require caution regarding external validity. Participants are regulars of a service geared towards health promotion, focusing on the practice of physical exercise and, therefore, more aware regarding their health, what sets them apart from the general population29 .This study assessed the food environment of the health service and not solely of the individual, which can be a limiting factor but, also, a differential. The health service analyzed seeks to build health environments and should, therefore, work in conjunction with other public policies of health in the territory. In addition, the study analyzed only aspects of the consumer’s food environment; however, aspects such as type of establishment, density and distance can be significant determinants for individual consumption. Nevertheless, this indicator considers the importance of the consumer environment, as study by the very participants of a qualitative studyResults showed that participants of a health promotion program consume the recommended amount of F&V but monotonously, despite the diversity, variety and reasonable quality of F&V in the commercial establishments around the PAS territories. As stated, food monotony reduces the spectrum of nutrients consumed, which can compromise the protective effect of F&V against chronic diseases. Educative actions, therefore, must work beyond the recommended quantities of foods, rescuing the food culture, culinary skills and the importance of the diversified intake of foods, as recommended by the diet guidelines for the Brazilian population. 1 , que em pouco tempo permitiu que inúmeros países fossem dominados pelo processamento de alimentos2 .Ao longo dos séculos, o homem desenvolveu tecnologias para melhorar a disponibilidade e a durabilidade dos alimentos. Passo importante nesse sentido foi a industrializaçãoin natura decresceu2 , incluindo as frutas e hortaliças (FH)4 . A inadequação no consumo de FH é um dos dez fatores centrais na determinação da carga global de doenças e caracteriza-se pela quantidade insuficiente ou falta de variedade, com consequente redução do repertório alimentar e a baixa ingestão de nutrientes5 .Como consequência da industrialização, o consumo de alimentos 6 . Entretanto, nenhum deles avaliou a diversidade de FH consumida. Nesse contexto, mesmo que as estratégias que visam ampliar o acesso e o consumo de FH sejam prioridade das políticas de saúde no mundo5 , elas se limitam a estimular e avaliar o consumo segundo as recomendações (cinco porções/dias). Em geral, não consideram a importância da diversidade na alimentação e pouco abordam o papel do ambiente alimentar sobre o consumo de alimentos, sobretudo em contextos coletivos como os serviços de saúde11 e em países em desenvolvimento.O consumo inadequado de FH é global e constantemente investigado por estudos e inquéritos populacionais de diversos países10 . Estudos demonstram que uma maior variedade e disponibilidade de alimentos no ambiente do consumidor pode favorecer o seu consumo14 . Um estudo de revisão conduzido nos Estados Unidos apontou que a baixa disponibilidade de FH estava associada à pior qualidade da alimentação14 .O ambiente pode tanto favorecer comportamentos insalubres como saudáveis, devido a sua forte interferência sobre as decisões de compra e escolhas dos indivíduosDiante do exposto, este artigo objetivou analisar a quantidade e a diversidade do consumo de FH e a sua relação com as características de aquisição e do ambiente alimentar do consumidor.10 e Menezes et al.15Trata-se de um estudo que analisou a linha de base (2013/2014) de um ensaio comunitário controlado e aleatorizado em amostra probabilística e representativa de unidades do Programa Academia da Saúde (PAS) de Belo Horizonte, Minas Gerais. A investigação contemplou os usuários do PAS e o ambiente alimentar no entorno de seus territórios. Outros detalhes da pesquisa podem ser vistos em Costa et al.17 . No município investigado o PAS oferta a prática de exercício físico orientado e ações de promoção da saúde em parceria com o Núcleo de Apoio à Saúde de Família (NASF)17 .O PAS foi escolhido como cenário da pesquisa por ser um ponto da Atenção Primária que visa contribuir para a construção de ambientes promotores de saúde. Para isso, conta com infraestrutura, equipamentos e quadro de pessoal qualificado para a orientação de modos saudáveis de vida, incluindo a promoção da alimentação adequada e saudável, e para ações de segurança alimentar e nutricionalInternational Committee of Medical Journal Editors (ICMJE) e a Organização Mundial de Saúde (OMS).O estudo foi conduzido dentro dos padrões exigidos pela Declaração de Helsinque e aprovado pelos comitês de ética em pesquisa da Universidade Federal de Minas Gerais (0537.0.0203.000-11) e da Prefeitura Municipal de Belo Horizonte (0537.0.0203.410-11A). Além disso, foi cadastrado no Registro Brasileiro de Ensaios Clínicos (RBR-9h7ckx), segundo os critérios requeridos pelo 10 , representativas do total, com nível de confiança de 95% e erro de 1,4%. Após a coleta de dados, visando verificar a manutenção da representatividade da amostra, foram realizadas análises estatísticas comparando os dados sociodemográficos de todas as unidades (n = 50) com os da amostra (n = 18), com nível de confiança e erro mantidos.No processo amostral, foram consideradas 42 unidades do PAS das 50 instaladas no município. Foram excluídas seis unidades localizadas em áreas de baixa vulnerabilidade à saúde por seu reduzido número no município e outras duas pela intensa realização de estudos de intervenção. Dessa forma, foram sorteadas 18  unidades distribuídas pelas nove regiões do município15 . Os critérios de inclusão eram: ter pelo menos 20 anos de idade e ter participado regularmente das atividades do PAS no mês anterior ao início da coleta de dados. Os critérios de exclusão foram ser gestante e ter comprometimento cognitivo que impossibilitasse responder ao questionário. Os dados da participação nas atividades foram coletados por meio do registro de frequência diária realizado pelo serviço, enquanto o comprometimento cognitivo foi constatado a partir da avaliação inicial do usuário no seu ingresso no PAS e da avaliação feita pela equipe de pesquisa17 .Nas unidades amostradas, todos os participantes foram convidados a participar do estudo (n = 3.763). Desses, 3.414  foram entrevistados, sendo contabilizadas 237 recusas  e 112 exclusões buffer com raio de 1.600 metros ao redor de cada unidade do PAS amostrada. Esta distância foi escolhida por ser factível para realizar as compras sem necessidade de transporte motorizado. Os dados dos estabelecimentos e feiras livres foram disponibilizados pelo município e adicionados àqueles encontrados espontaneamente no território das unidades do PAS durante a visita aos estabelecimentos registrados10 .Para caracterizar o ambiente alimentar, foram investigados os estabelecimentos que comercializavam FH e feiras livres contidas em um A coleta de dados foi realizada por acadêmicos de nutrição e profissionais de saúde treinados semestralmente para o uso dos instrumentos e a condução de entrevistas, sob a orientação de supervisor de campo e do pesquisador principal. Os dados passaram por análise de consistência antes e após a tabulação.19 e contemplou características sociodemográficas e econômicas, aspectos de saúde, perfil de aquisição, estado nutricional e consumo de FH .As informações dos indivíduos foram obtidas por questionário submetido a estudo piloto e aplicado face a face por entrevistadores treinados. Foi construído a partir de estudos nacionais e experiência pregressa do grupo de pesquisa19 , que investigou a frequência  e o número de porções consumidas. Para verificar a diversidade do consumo, foi aplicado o Questionário de Frequência Alimentar (QFA) específico, relativo aos últimos seis meses, incluindo 14 frutas e 22 hortaliças. A diversidade foi avaliada pelo consumo diário das FH analisadas19 . Para caracterizar o perfil de aquisição de FH, utilizaram-se as variáveis relativas ao conhecimento sobre o conceito de safra de alimentos e disponibilidade de FH no domicílio, além de frequência e tipo de estabelecimento escolhido para a compra de FH15 .Para registrar o consumo de FH, utilizou-se o Questionário Breve de Avaliação do Consumo de Frutas e Hortaliças (QBreve-FH), validado para a população de estudo20 .As características sociodemográficas e econômicas investigadas foram sexo, idade, escolaridade (anos), estado civil  e ocupação . Bens materiais na residência e o grau de instrução do chefe da família foram utilizados para a classificação econômica dos participantes em cinco classes, de A (a mais rica) até a E (a mais pobre), segundo o Critério de Classificação Econômica BrasilAspectos de saúde foram avaliados pelo autorrelato de diagnóstico médico de diabetes, hipertensão arterial e dislipidemia, assim como pela percepção de saúde . Além disso, coletaram-se informações sobre a frequência (dias) e duração (minutos) da prática de exercícios físicos e sobre o tempo de participação do usuário no PAS (diferença entre as datas de coleta dos dados e do ingresso do usuário no programa).21 . O peso foi aferido por medida única em balança digital da marca Marte®, com capacidade para 180 kg e precisão de 100 g. A estatura também foi verificada por medida única em estadiômetro portátil, marca Alturexata®, com capacidade para 220 cm, adotando as técnicas preconizadas pelo Ministério da Saúde22 .Para a avaliação do estado nutricional, foram utilizadas as medidas antropométricas de peso e altura, com base nos quais foi calculado o índice de massa corporal (IMC), classificado conforme critérios definidos pela OMS23 . Foram verificadas as seguintes características do ambiente do consumidor para as FH: diversidade, variedade e qualidade. Para isso, utilizaram-se instrumentos desenvolvidos e validados para o contexto brasileiro24 , que foram adaptados incluindo os 10 tipos mais adquiridos de frutas e hortaliças em Belo Horizonte , conforme a Pesquisa de Orçamentos Familiares 2008–20098 .Realizou-se visita a lojas de conveniência, mercado municipal, sacolões de rede privada e subsidiados pela prefeitura, mercados locais ou de bairro, supermercados de grandes redes, hipermercados, supermercados de atacarejo e padarias24 .A diversidade foi avaliada pelo o número de FH disponíveis no estabelecimento, enquanto a variedade foi pelo número de diferentes tipos de FH de uma mesma espécie . A qualidade foi classificada em boa ou ruim a partir de avaliação subjetiva, considerando a presença de manchas e machucados ou aparência de “passado” ou maduro demaisO consumo de FH foi analisado em quintis de porções diárias consumidas e descrito de maneira agregada segundo as unidades do PAS investigadas. Já as características do ambiente alimentar foram analisadas segundo as unidades do PAS.Para verificar a associação entre as características dos participantes e os quintis de consumo de FH, utilizou-se o teste estatístico de qui-quadrado de tendência linear para as variáveis categóricas e análise de variância (Anova) para as variáveis contínuas. A regressão linear multinível foi utilizada para avaliar se os indicadores do perfil de aquisição de alimentos  e do ambiente alimentar do consumidor  explicavam as variações no consumo quantitativo (porção/dia) e qualitativo (diversidade diária) de FH. Essa análise permite considerar a estrutura hierárquica do nível de agregação dos dados, além da inserção de variáveis individuais e contextuais. Assim, o consumo individual (porções diária e diversidade) de FH consistiu nos dois desfechos analisados, com os participantes (nível 1) aninhados de acordo com as unidades do PAS (nível 2).Além do perfil de aquisição de alimentos no nível individual, foram adicionadas variáveis sociodemográficas para ajustamento do modelo. A construção do modelo se deu de forma hierárquica, sendo primeiro construído o modelo nulo (com inclusão apenas do intercepto randômico), seguido da inserção das variáveis individuais, e por fim das variáveis do ambiente. Os modelos finais mostraram as variáveis que apresentaram maior associação  com os desfechos porções de FH e diversidade consumida, após ajuste pelas variáveis individuais. Destaca-se que esses são modelos com intercepto aleatório, que não apresentam esse padrão para os coeficientes (de efeitos fixos).O coeficiente de correlação intraclasse (ICC) foi quantificado para analisar a variabilidade dentro e entre os territórios, fornecendo a proporção da variabilidade total, que depende das diferenças entre os territórios. A porcentagem de variação proporcional na variância (PVP) foi calculada entre o modelo nulo e o modelo final, visando analisar o quanto as covariáveis explicaram a variação nos desfechos entre os territórios.Stata Corp., College Station , TX, USA), e a significância estatística foi estabelecida em 5%.Todas as variáveis foram analisadas no programa Stata/SE versão 14.0  e adultos de meia idade , com consumo médio relatado de 5,4  porções de FH de dois tipos diferentes por dia   .Participantes no último quintil de consumo de FH , comparados com os do primeiro , apresentavam idade mais avançada, maior proporção de aposentados, de portadores de alguma doença crônica e de indivíduos mais ativos fisicamente. As mulheres relataram maior consumo de FH, que reduziu com o aumento dos quintis de FH, situação oposta à dos homens   .Indivíduos no último quintil de consumo de FH relataram ingerir maior diversidade desses alimentos que os do primeiro quintil   . As priAs características do ambiente alimentar do consumidor segundo as unidades do PAS investigadas estão apresentadas na 2= 2,04, ICC = 0,011; modelo nível 1: σ2= 2,02, ICC = 0,009; modelo níveis 1 e 2: σ2= 2,01, ICC = 0,004), indicando que as covariáveis inseridas auxiliaram a explicar o consumo de FH. Alinhado a esse resultado, o cálculo da PVP demonstrou que as covariáveis do modelo explicaram 34,7% da variável do consumo quantitativo de FH.Na análise multinível, após ajuste por variáveis sociodemográficas, verificou-se que o conhecimento sobre safras de alimentos e o aumento da disponibilidade mensal no domicílio e da frequência de compra de frutas poderia aumentar o consumo (porções/dia) de FH   . Em relAs variáveis do perfil de aquisição de alimentos investigadas não se associaram à diversidade de FH consumidos, mas as variáveis de oferta dos territórios, sim. As covariáveis inseridas no modelo ajudaram a explicar 28,3% da variedade do consumo de FH.Os participantes desse programa de promoção da saúde, parte da atenção primária brasileira, relataram consumo adequado de FH (média diária de cinco porções). Entretanto, ao avaliar o consumo qualitativamente, verificou-se monotonia alimentar, com uma média de apenas dois tipos diferentes de FH ingeridos por dia. O perfil de aquisição de FH interferiu no consumo, com destaque para o conhecimento sobre safras de alimentos e frequência de compra e disponibilidade domiciliar de frutas. O ambiente alimentar do consumidor, por sua vez, demonstrou ser importante tanto para o consumo quantitativo (porções/dia) como para o qualitativo (diversidade do consumo).7 . Na Inglaterra (2011/2012), 70% dos adultos e 59% dos idosos não consumiam a quantidade recomendada de FH3 . Nos Estados Unidos, o consumo diário médio de tais alimentos é de 2,7 porções ao dia4 . Na América Latina, em países como Argentina (2013) e Chile (2009/2010), 5,0% e 84,3% da população, respectivamente, não apresentavam consumo adequado7 . Pesquisas realizadas no Brasil (de 1987 a 2009) evidenciam declínio das quantidades médias adquiridas25 e do consumo de FH26 , estimando que menos de 10,0% da população apresentava consumo adequado8 .Essa quantidade foi surpreendentemente superior aos valores nacionais e internacionais27 verificaram inadequação de 75,3% no consumo de FH. Parte da diferença dos resultados pode ser atribuída ao tempo de participação do usuário no serviço de saúde; a média deste estudo era de 20 meses. A participação em serviço de promoção da saúde, ainda que voltado para a prática de exercícios físicos, parece potencializar a adoção de outros hábitos saudáveis de vida, como a alimentação saudável, além de melhorar o acesso a conhecimentos como os referentes à safra dos alimentos16 .A ingestão encontrada neste estudo também foi superior à identificada em outro trabalho realizado no PAS. Ao analisar os ingressantes de um triênio (2008 a 2010) no PAS, Costa et al.. Tal resultado revela um possível caminho para os governos promoverem mudanças positivas nesse aspecto. Entretanto, ele também aponta o desafio da monotonia alimentar e a iminente necessidade de sua discussão no contexto das recomendações e das ações educativas, resgatando e elucidando a mensagem da OMS de que o consumo adequado consta da ingestão regular, diversificada e quantitativamente recomendada de frutas e hortaliças5 .Neste estudo, portanto, observou-se o potencial desse serviço de promoção da saúde para reverter a deterioração quantitativa do consumo de FH 28 . A diversidade alimentar insuficiente pode prejudicar a manutenção de hábitos alimentares saudáveis em longo prazo, resultando na redução do repertório de alimentos da população e no menor teor nutricional da alimentação.Há mais de 200 tipos de frutas e hortaliças presentes em diferentes culturas, que se diferenciam pela densidade calórica, quantidade de água e diversidade de micronutrientes, os quais acarretam benefícios para a saúde e proteção contra doenças29 .A baixa diversidade no consumo de FH pode também se relacionar ao menor preço, tempo e complexidade exigida para o preparo dos alimentos, assim como a uma tentativa de superar obstáculos como baixa qualidade das FH. Tais questões se tornam ainda mais relevantes ao considerar que foram estudadas áreas vulneráveis, com média de renda abaixo da população brasileira10 . O ambiente alimentar deve apoiar escolhas saudáveis, ofertando opções amplas de alimentos acessíveis, variados e de qualidade. Este estudo reforça essas informações ao sugerir que as variáveis do ambiente alimentar do consumidor  foram importantes, além de questões relativas à aquisição de FH. Em concordância com os resultados, em um trabalho realizado no Brasil, o relato de mulheres sobre a aquisição de alimentos revelou que a variedade de FH nos estabelecimentos impactava a aquisição de alimentos saudáveis em detrimento dos alimentos ultraprocessados30 .Um estudo prévio sobre estabelecimentos comerciais no território do PAS de Belo Horizonte demonstrou que em algumas unidades havia acesso limitado a estabelecimentos com adequada disponibilidade e variedade de FH28 . Além disso, pouco ainda se sabe sobre a influência do ambiente do consumidor na alimentação, situação que evidencia como ainda se trata a alimentação fora da complexidade na qual está imersa.Nossos resultados enfatizam a importância de promover a alimentação adequada, diversificada e saudável na atenção primária à saúde, tendo em vista a sua potencialidade de incentivar modos saudáveis de viver. Entretanto, é preciso avançar para além da adequação quantitativa e dos fatores associados, estudando também a diversidade consumidaSugere-se a realização de mais estudos, visando compreender melhor a relação entre consumo, monotonia e ambiente alimentar (oferta e demanda) e buscando responder a questionamentos como: o ambiente restrito gera a monotonia alimentar ou é a monotonia alimentar (demanda pouco diversificada) que leva à oferta precária de alimentos no território?9 . Entretanto, os resultados mostram a importância de trabalhar em outros cenários de pesquisa, bem como de entender as ações ofertadas nos serviços de saúde como possíveis caminhos para enfrentar os desafios enfrentados pelo setor. A dificuldade para obter medidas fidedignas do consumo de alimentos tem sido apontada como importante limitador na literatura19 , o que não foi diferente neste estudo. A avaliação do consumo com perguntas específicas para FH associadas com exemplos de alimentos, em especial de hortaliças, também pode ter influenciado os dados de quantidades consumidas. Um estudo de validação dos dados mostrou boa precisão do relato do consumo de frutas, mas com necessidades de ajustes para a ingestão de hortaliças19 .Esses resultados, apesar de inéditos e relevantes, requerem cautela quanto à validade externa. Os participantes são frequentadores de um serviço direcionado para a promoção da saúde, com enfoque na prática de exercício físico, e, portanto, mais conscientes quanto à sua saúde, o que os diferencia da população em geral29 .Este trabalho avaliou o ambiente alimentar do serviço de saúde e não exclusivamente do indivíduo, o que pode ser um limitante, mas também um diferencial. O serviço de saúde analisado busca a construção de ambientes saudáveis, devendo, portanto, trabalhar de maneira integrada com outras políticas públicas de saúde do território. Além disso, o estudo analisou apenas aspectos do ambiente alimentar do consumidor, mas aspectos como tipo de estabelecimento, densidade e distância podem ser determinantes consideráveis para o consumo individual. Contudo, pondera a importância dos aspectos do ambiente do consumidor, como afirmado pelos próprios participantes em estudo qualitativoOs resultados revelam que participantes de um programa de promoção da saúde consomem FH na quantidade recomendada, mas de forma monótona, apesar da diversidade, variedade e qualidade razoável de FH nos estabelecimentos comerciais no entorno dos territórios do PAS. Como dito, a monotonia alimentar reduz o espectro de nutrientes consumidos, podendo comprometer o efeito de proteção das FH contra doenças crônicas. Ações educativas, portanto, devem trabalhar para além das recomendações de quantidades de alimentos, resgatando a cultura alimentar, habilidades culinárias e a importância do consumo diversificado de alimentos, conforme preconizado pelas diretrizes alimentares para a população brasileira.


To compare two endotracheal suctioning protocols according to morbidity, days of mechanical ventilation, length of stay in the Pediatric Intensive Care Unit (PICU), incidence of Ventilator-Associated Pneumonia (VAP) and mortality. A Pragmatic randomized controlled trial performed at University Hospital Pablo Tobón Uribe, Medellin-Colombia. Forty-five children underwent an as-needed endotracheal suctioning protocol and forty five underwent a routine endotracheal suctioning protocol. Composite primary end point was the presence of hypoxemia, arrhythmias, accidental extubation and heart arrest. A logistic function trough generalized estimating equations (GEE) were used to calculate the Relative Risk for the main outcome.Characteristics of patients were similar between groups. The composite primary end point was found in 22 (47%) of intervention group and 25 (55%) children of control group , as well in 35 (5.8%) of 606 endotracheal suctioning performed to intervention group and 48 (7.4%) of 649 performed to control group .There were no differences between an as-needed and a routine endotracheal suctioning protocol. ClinicalTrials.gov identifier NCT01069185  The percentage of intubation and mechanical ventilation in the pediatric intensive care unit (PICU) varies between 17% and 64% with an median duration of 7 days-In the literature there are recommendations regarding the pressure of the suction, the suction systems, the duration of the procedure, the depth of the insertion of the catheter and its size, but there is controversy concerning the frequency to apply the ET suctioning, such as its impact on the duration of the respiratory support, the length of stay in the PICU, the incidence of infections associated to the health care and the accidental extubationsTaking into account the multiple risks that represent the ET suctioning for the pediatric population, which increases with its frequency, the fact of decreasing the number of suctions could be reflected in a decrease of accidental extubations and its consequences, such as the negative inherent effects from the suctions.In this clinical trial, both protocols of ET suctioning were compared, to identify if there are differences in the frequency of the morbidity associated to this, days of mechanical ventilation, the length of stay in the PICU, the incidence of Ventilator-Associated Pneumonia (VAP) and mortality in the PICU.This pragmatic, parallel, unblinded, randomized controlled trial considered for random allocation, all children over a month up to 14 years plus 364 days, hospitalized in the PICU who required endo-tracheal intubation and mechanical ventilation, whose parents accepted to sign the waived informed consent. Excluded from the study were those patients with high-frequency oscillatory ventilation, due to the depressurization risk because of suctioning and the difficulty of visualizing the pattern of presence of secretions in children submitted to this type of ventilation.This study was conducted over a six-month period at University Hospital Pablo Tobón Uribe, located in Medellín-Colombia, which has 313 beds, 10 in pediatric ICU with 72 discharges per year. The study protocol was reviewed and approved by Ethics Committee of the Hospital. Group allocation to either as-needed or routine ET suctioning protocol, was obtained using The RAND software by random sequence numbers distributed over permutated blocks size of 4,6 and 8 generated by the head investigator who was not involved in patient care. The patients were randomized immediately after intubation. The allocation concealment of the sequence was applied by sequentially numbered, sealed, opaque envelopes kept by Hospital’s Research Unit.TM catheter which was introduced in the ETT avoiding contact with the airway and applying negative pressure, between 20 and 40 mmHG, according to patient’s age, for a maximum period of 10 seconds. This technique was repeated until the airway remained patent which was assessed by the evidence of non-secretions in the aspirator as well as in the flow pattern. The size of the catheter was protocolized. As a rule, we assigned the catheter with double the number of the tube the child has: for a number 3 tubes we use a number 6 catheter, for a number 4 tubes we use a number 8 catheter The guides of aseptic technique for ET suctioning practice were considered. After obtaining the informed consent from parents, the practice of the ET suctioning was applied in both groups using a Trach CareIn the intervention group, the practice of ET suctioning was applied as-needed according to the presence of one or several of the following criteria displayed on the ventilator monitor or bydirect observation:Oxygen saturation less than 90%  not secondary to movement or loss of the pulse wave, for duration of at least one minute and with previous normal saturation. Tidal volume less than or equal to 5 mL/kg of what the patient mobilized before the ES and whose decrease was not secondary to a previous manipulation. For each patient the pediatrician on duty calculated the absolute ideal tidal volume in mL/kg and the minimum allowed tidal volume, which was programmed in the ventilator alarm. A fall in the tidal volume was considered having as reference the absolute ideal tidal volume that the patient had. This value was taken from the evolution notes of the respiratory therapist and the pediatrician. Pressure parameters like PEEP and pressure control were not considered.Curve of flow/time that showed changes of graphics or the presence of “saw-toothed pattern” which indicated the presence of secretions in ETT. The presence of water in the ventilator tubing was ruled out.Asynchrony of the respiratory pattern with the ventilator: irregular and uncoordinated respiratory pattern with the ventilatory mode.Audible and visible secretions.In the control group, the practice of ET suctioning was performed as a routine form every two hours. In this group the frequency of suction could be modified if the patient presented whichever criteria defined for the intervention group, remaining in the assigned treatment arm. There was no additional sedation applied during the practice of ET suctioning. It should be noted that an active moistening servo controlled by humidifier Fisher and Pyker MR 290 was used.Due to the inability to blind the intervention, the frequency of the following co-interventions that were part of basic nursing care, which could be modified by the group knowledge and at the same time could affect the expected results, were quantified: changes of position, bath in bed, fixation of the ETT and sedation. A staff different from the research team performed this evaluation.A primary end point of morbidity was established, which was composed by four components defined as follows:Hypoxemia as the drop in saturation of 10% of the previous value to the ET suctioning, presented during or immediately ending the suction.Accidental extubation events Cardio respiratory arrest.th percentile for patient’s age or tachycardia if heart rate was greater than 90th percentile for patient’s age or if there was an increase of 10% for those patients that had tachycardia before the suction.Arrhythmias as the alteration of heart rhythm-based, presented during or immediately ending the suction and considered as: bradycardia if heart rate was below the 5Extrasystoles like the presence of premature beats compared to the normal rate, identified by the nursing assistant, verified by the pediatrician in monitors. The data for the registration of these adverse events were collected from the central monitor CNS Nihon Kohden V 01-55 9701J with the help of the Vorax 5001 software Spanish version.Secondary outcomes were defined as follows:Ventilator-Associated-Pneumonia (VAP) whose definition was based on the criteria of the “Center Disease Control” (CDC) in Atlanta and its diagnosis was checked by the Infections Prevention Committee.Days of mechanical ventilation and stay in the PICU accounted every day at 7 hours and 30 minutes. This measurement was the duty of the Infections Prevention Committee from Monday to Friday. During weekends and holidays, the person in charge of the measurements was the nurse on duty. For the calculation, it was taken into account the date, time entry and discharge in the PICU in the registration of the electronic health record.Measurements of the cardiopulmonary parameters were done by the nursing assistant, the nurse, the respiratory therapist or the pediatrician and were recorded in a standardized registration sheet. A different physician from the treating group assigned the diagnosis according to analyses done on such data. There were considered additional variables such as: The age in months, the gender, the weight in kilograms, the diagnosis of the PICU admission recorded in the electronic health record by the pediatrician and the PRISM  calculated for the first 24 hours of admission to the PICU.Outcomes included were the events occurred during the PICU stay only.,Calculation was based on findings from the literature. We assumed a proportion of events in the control group of 45% and an expected decline of 25% in the intervention group p value less than 0.05 was considered statistically significant. To estimate the relative risk of the primary composite end point was considered the fact that responses were correlated. It was necessary to model the data using techniques for dichotomous outcomes by generalized estimating equations (GEE). Within the model, the number that identified each patient in the data base represented the variability between-subject and the measurements ET suctioning represented the variability within-subject. The type of model chosen was the binary logistic response. The dependent variable was the primary composite end point, the category of reference was the control group and as predictable factors the ET suctioning protocol (routine or as-needed) and the number (episodes) of ET suctioning were used. The choice of “working correlation structure” was assessed and the model was chosen considering the lowest values for standard errors and for the quasi-likelihood criteria of goodness-of-fit statistic ® version 19.0 for windows was used.The randomly assigned units were the patients and the analysis units were the suctions. For those demographic and clinical characteristics of the population represented in dichotomous variables, absolute and relative frequencies were calculated. For continuous variables, the normal distribution of the data was assessed by measures of central tendency, measures of distribution, graphics and the Shapiro-Wilk test. Due to the skewed distribution of the data, medians were used with its respective interquartile range (IQR). For bivariate analysis of categorical variables, the Chi square statistic was used. In those cases were the marginal expected values were lower than 5, continuity correction was applied. Continuous variables were compared with Mann-Whitney test. For both types of variables, a During the study period, 183 patients were admitted to the PICU. Of these patients, 92 were randomly assigned to receive as-needed or routine ET suctioning protocol. Finally, 45 patients received as-needed ET suctioning and 45 received routine ET suctioning. There was no lost to follow up due to each patient was followed until discharge from the PICU .From the recruited population, 52% (48/92) were male patients. Median age was 40.5 months (IQR 8.3 - 107.1). The reasons for admission to the PICU were the infectious diseases in 16% (15), congenital diseases in 12% (11), neurological and surgical diseases in 11% (10), cardio vascular diseases in 9% (8), respiratory diseases in 8% (7) and 34% (31) got admitted for other causes. Of the admitted participants, 23% (21) died. The median of the PRISM score for the randomly assigned population was 22 points (IQR:15-26). Most children (44%) at the admission showed a low risk of death (PRISM >20 points). The median duration of mechanical ventilation and stay in the PICU, was of 2.5 days (IQR:1.0-5.7) and 5.8 days (IQR:2.0-14.6) respectively. Ninety-eight per cent of the participants received sedation, bed bath and position changes according to the nursing care protocol. The protocol of fixation of the ETT was applied to 96% (88) of the participants; as there were four participants who entered with tracheotomy. p= 0.31). There was only one case of VAP in the control group without statistical significance between the groups (p= 0.98). In the intervention group the median of the length of mechanical ventilation was 2.5 days (1.0-5.0) vs. 2.4 days (0.8-6.4) in the control group, without statistical significance (p= 0.93). The length of stay in the PICU was longer for the intervention group with a median of 6.0 days (1.8-12.6) vs. 4.4 days (2.4-22) in the control group (p= 0.76). In an exploratory analysis was discovered that 12 (26.7%) participants died in the control group and 9 (19.1%) died in the intervention group (p= 0.39) during the intervention period. There was not follow-up after PICU discharge.Patient clinical characteristics and demographic data were similar between the two groups . The medThis trial suggests that the application of one as-needed ET suctioning protocol compared to one of routine ET suctioning, does not present differences in the frequency of morbidity for the children who were admitted to the PICU. Although indicated to declare equality between two interventions it is necessary to perform a non-inferiority trial, the small difference found between the two groups, with minimal clinical significance, suggests that both interventions are similar with respect to adverse events, consistent with current recommendations of clinical guidelines.,The clinical guidelines of the “American Association Respiratory Care” (AARC) for the practice of the ET suctioning in patients with mechanical ventilation and artificial airway recommend that routine suctioning should be avoided, reinforced by the results of three clinical trials, however, one was conducted on adults ,,There exist several observational studies in the pediatric population, which have described the incidence of adverse events associated to the practice of the ET suctioning, and have been reviewed recently The absence of accidental extubation during the practice of the ET suctioning in this trial differs from the others reported , where the practice of procedures like the ET suctioning was described like one of the risk factors for accidental extubation and it has been described that ET manipulation at the time of unplanned extubation in the neonatal ICU ranged from 17% to 30% of all patients who had unplanned extubation There were no additional efforts or necessity for more personal to practice the “as needed protocol”. Using this protocol, the time between aspirations were doubled. The released time was using for provide other cares that gave more benefits for the patients. However, this outcome was not objectively measured having account it was not the aim of the study. One limitation of this study was the low frequency for the primary outcome, lower than estimated from those reported in the literature, which affects the power of the study, however, the difference found between the two groups is very small and was also lower than estimated from observational studies, therefore is considered to be plausible to accept that the failure to detect significant differences in the frequency of endpoints between the two groups was not due to the decline in power of the study. A second limitation was the lack of blinding, which is impossible to avoid considering the type of intervention implemented, but tried to control by assessing the outcome by staff independent of the research team and indirectly evaluating the possibility that this knowledge would induce other differential co-interventions, which did not appear. There was also difficulty to define objectively the components of the primary outcome. A recent Cochrane review of frequency of endotracheal suctioning for the prevention of respiratory morbidity in ventilated newborns find that the ideal frequency of ET suctioning has been investigated in few studies, identified only one randomized controlled study from 1991for inclusion in the revision and concluded that there was insufficient evidence to identify the ideal frequency of ET suctioning in ventilated neonates  El porcentaje de intubación y ventilación mecánica en la Unidad de Cuidado intensivo pediátrico (UCIP) varía entre 17 y 64% con una mediana de duración de 7 días -En la literatura existen recomendaciones relacionadas con la presión de succión, los sistemas de aspirado, la duración del procedimiento, la profundidad de inserción del catéter y el tamaño del mismo, pero existe controversia con respecto a la frecuencia para realizar la AE, así como el impacto de la misma en la duración del soporte ventilatorio, la duración de la estancia en la unidad de cuidados intensivos pediátricos (UCIP), la incidencia de infecciones asociadas al cuidado de la salud y las extubaciones accidentales Teniendo en cuenta los múltiples riesgos que representa la AE para la población pediátrica, los cuales se aumentan con su frecuencia, el hecho de disminuir el número de aspiraciones se podría reflejar en una disminución de las extubaciones accidentales y sus consecuencias, así como los efectos negativos inherentes a la aspiración.En este ensayo clínico se comparan ambos protocolos de AE, para identificar si hay diferencias en la frecuencia de la morbilidad asociada a la aspiración, los días de ventilación mecánica, la duración de la estadía en la UCIP, la incidencia de neumonía asociada al ventilador (NAV) y la mortalidad en la UCIP.Este ensayo clínico pragmático, paralelo, abierto, controlado y aleatorizado consideró para la asignación al azar a todos los niños mayores de un mes hasta los 14 años más 364 días, hospitalizados en la UCIP que necesitaron intubación endotraqueal y ventilación mecánica, cuyos padres aceptaron firmar el consentimiento informado. Se excluyeron del estudio aquellos pacientes con necesidad de ventilación mecánica de alta frecuencia, debido al riesgo de despresurización por la práctica de la aspiración y a la dificultad de visualizar el patrón de presencia de secreciones en niños sometidos a este tipo de ventilación.Este estudio se desarrolló durante un período de 6 meses en el Hospital Universitario Pablo Tobón Uribe, ubicado en Medellín-Colombia, el cual cuenta con 313 camas, 10 en la UCIP, con 72 egresos al año. El protocolo del estudio fue revisado y aprobado por el Comité Institucional de ética.La asignación al azar al grupo de AE a necesidad o rutinaria, se obtuvo mediante el uso del programa RAND mediante una secuencia de números aleatorios distribuidos por bloques permutados de tamaño 4, 6 y 8 generada por la investigadora principal que no hacía parte del equipo asistencial. El ocultamiento de la secuencia se realizó por medio de sobres opacos sellados, numerados secuencialmente en la Unidad de Investigación del Hospital. Los pacientes fueron asignados a los grupos inmediatemente después de la intubación ™ la cual era introducida en el TET evitando tocar la vía aérea y aplicando presión negativa, entre 20 y 40 mmHG, según la edad del paciente, por un período máximo de 10 segundos. Esta técnica fue repetida hasta que la vía aérea quedara permeable, lo cual fue verificado mediante la observación de ausencia de secreciones en el aspirador y del patrón del flujo. El tamaño del catéter a utilizar estaba protocolizado, como norma, se asignó un catéter con el doble del número del tubo que tuviera el niño: para los tubos número 3 se usó un catéter número 6, para los tubos número 4 se usó un catéter número 8 Se tuvieron en cuenta las normas de la técnica aséptica para AE. Posterior a la obtención del consentimiento informado por los padres, la práctica de la AE fue realizada en ambos grupos utilizando un catéter Trach Carea necesidad según la presencia de uno o varios de los siguientes criterios visualizados en el monitor del ventilador o con la observación directa:En el grupo de Intervención, la práctica de la aspiración se realizó Saturación de oxígeno menor de 90%  no secundaria a movimiento, o pérdida de la onda de pulso, de al menos un minuto de duración y con saturaciones previas normales. Volumen corriente menor o igual a 5 mL/kg de lo que el paciente movilizaba antes de la AE y cuya disminución no fuera secundaria a manipulación previa. Para cada paciente el pediatra de turno calculó el volumen corriente absoluto ideal en mL/kg y el volumen corriente mínimo permitido, el cual se programó en la alarma del ventilador. Se consideró la caída en el volumen corriente teniendo como referencia el volumen corriente absoluto ideal que tenía el paciente. Este valor se tomó de las notas de la evolución del terapeuta respiratorio y del pediatra. No se consideraron parámetros de presión como PEEP y control de presión.Curva flujo/ tiempo que mostrara la presencia de patrón en “dientes de sierra o melladura” que indicaran presencia de secreciones en el tubo. Se descartaba la presencia de agua en el tubo del ventilador.Asincronía del patrón respiratorio con el ventilador: patrón respiratorio irregular y descoordinado con el modo ventilatorio.Secreciones visibles y audibles.forma rutinaria cada dos horas. En este grupo la frecuencia de la aspiración podía ser modificada si el paciente presentaba cualquiera de los criterios definidos para el grupo de intervención, permaneciendo en el brazo del tratamiento asignado.En el grupo Control la práctica de la aspiración se realizó de Debido a que no fue posible el enmascaramiento de las intervenciones, se cuantificó la frecuencia de las siguientes co-intervenciones que se encuentran protocolizadas dentro de los cuidados básicos de enfermería y que se podrían modificar por el conocimiento de los grupos y que a la vez pueden afectar los resultados esperados: cambios de posición, baño en cama, fijación del TET y sedación. Esta evaluación la realizaron personas diferentes al equipo investigador. Se estableció un desenlace primario de morbilidad, el cual fue compuesto por cuatro componentes definidos así:Hipoxemia como la caída en la saturación del 10% del valor previo al procedimiento, presentada durante o inmediatamente terminaba la aspiración. Extubación accidental paro respiratorio. Arritmias como la alteración del ritmo cardíaco de base, presentadas durante o inmediatamente terminaba la aspiración y consideradas como: bradicardia si la frecuencia cardíaca era menor del percentil 5 para la edad o taquicardia si la frecuencia cardíaca era mayor del percentil 90 para la edad o había un incremento del 10% para aquellos pacientes que se encontraban taquicárdicos antes de la aspiración. Extrasístoles como la presencia de latidos adelantados respecto a la frecuencia normal, identificados por la auxiliar de enfermería y verificados por el pediatra y grabados en los monitores. Los datos para el registro de estos eventos adversos se tomó del monitor central CNS Nihon Kohden V 01-55 9701J con ayuda de la versión en español del software Vorax 5001.Se definieron los siguientes desenlaces secundarios:Center Disease Control” (CDC) de Atlanta y el diagnóstico lo verificó el Comité de Prevención de infecciones.Neumonía asociada al ventilador cuya definición se basó en los criterios del “Días de ventilación mecánica y estancia en la UCIP contabilizados todos los días a las 7 horas y 30 minutos. Esta medición estuvo a cargo del Comité de prevención de infecciones de lunes a viernes. Durante fines de semana y festivos, la responsable de la medición era la enfermera jefe del servicio. Para el cálculo, se tuvo en cuenta la fecha, hora de ingreso y egreso a la UCIP en el registro de historia clínica electrónica. Probability Risk Infant Score Mortality) calculado durante las primeras 24 horas de ingreso a la UCIP. Las mediciones de los parámetros cardiopulmonares fueron realizados por la auxiliar de enfermería, la profesional de enfermería, la terapeuta respiratoria o el pediatra y fueron consignados en una hoja de registro estandarizada. Un médico diferente al grupo tratante asignó los diagnósticos de acuerdo al análisis hecho a tales datos. Se consideraron variables adicionales como: edad en meses, sexo, peso en kilogramos, diagnóstico de ingreso a la UCIP consignado en la historia clínica electrónica por el pediatra y el PRISM . Dentro del modelo, el número que identificó cada paciente en la base de datos representó la variabilidad entre-sujeto y las mediciones de AE representó la variabilidad intra-sujeto. El tipo de modelo elegido fue el de respuesta logística binaria. La variable dependiente fue el desenlace primario compuesto, la categoría de referencia fue el grupo control y como factores predictores se ingresaron el método de AE (rutinario o a necesidad) y el número de AE. Se evaluaron las estructuras de las matrices de correlación de trabajo y el modelo elegido fue aquel que presentó los menores valores para el error típico y para el criterio de cuasi-verosimilitud de la bondad de ajusteLa unidad de asignación al azar fueron los pacientes y la unidad de análisis fueron las aspiraciones. Para aquellas características basales de la población representadas en variables categóricas se calcularon frecuencias absolutas y relativas. Para las variables continuas, se evaluó la distribución normal de los datos por medio de las medidas de tendencia central, las medidas de distribución, los gráficos, y la prueba de Shapiro-Wilk. Debido a que la distribución de los datos no fue normal, se utilizaron medianas con su respectivo rango intercuartílico (RIC). Para el análisis bivariado de las variables cualitativas, se utilizó el estadístico de ChiDurante el periodo de estudio, se admitieron 183 pacientes a la UCIP. De estos pacientes, 92 fueron asignados al azar para recibir AE a necesidad o rutinaria. Finalmente 45 pacientes recibieron AE a necesidad y 45 recibieron AE rutinaria. No hubo pérdidas de seguimiento debido a que cada paciente se siguió hasta el alta de la UCIP .De la población reclutada, 52% (48/92) fueron hombres. La mediana de edad fue 40.5 meses (RIC: 8.3-107.1). Los motivos de ingreso a la UCIP fueron las enfermedades infecciosas en 16% (15), enfermedades congénitas en 12% (11), enfermedades neurológicas y quirúrgicas en 11 % (10), enfermedades cardiovasculares en 9% (8), enfermedades respiratorias en 8% (7) y 34% (31) ingresaron por otras causas. De los participantes admitidos, 23% (21) falleció. La mediana del puntaje PRISM para la población asignada al azar fue de 22 puntos (RIC: 15-26). La mayoría de los niños (44%) al momento del ingreso presentó riesgo bajo de fallecer (PRISM <20 puntos). La mediana de la duración de la ventilación y de la estancia en UCIP, fue de 2.5 días (1.0-5.7) y 5.8 días (2.0-14.6), respectivamente. El 98% de los participantes recibió sedación, baño en cama y cambios de posición de acuerdo con el protocolo de cuidados de enfermería. El protocolo de fijación de TET, se aplicó al 96% (88) de los participantes, pues hubo cuatro participantes que ingresaron con traqueostomía. p= 0.31). Sólo se presentó un caso de neumonía asociada al ventilador en el grupo control sin diferencias estadísticamente significativas entre los grupos (p= 0.98). En el grupo de intervención la mediana de la duración de la ventilación mecánica fue de 2.5 días (1.0-5.0) versus 2.4 días (0.8-6.4) en el grupo control sin diferencias estadísticamente significativas (p= 0.93). La duración de la estancia en la UCIP fue mayor para el grupo de intervención con una mediana de 6.0 días (1.8-12.6) versus 4.4 días (2.4-22) en el grupo control (p= 0.76). De forma exploratoria se encontró que el 22.8% (21) del total de participantes falleció. La mayoría de estos (27%), se encontraba en el grupo control (p= 0.39). No hubo seguimiento después del egreso de la UCIP.Las características clínicas y demográficas de los pacientes fueron similares entre los dos grupos . La mediEste ensayo sugiere que la aplicación de un protocolo de AE a necesidad comparado con uno de AE rutinaria, no presenta diferencias en la frecuencia de la morbilidad para los niños que ingresan a la UCIP. Aunque se reconoce que para declarar la igualdad entre dos intervenciones es necesario realizar un ensayo de no inferioridad, la pequeña diferencia encontrada entre los dos grupos, con mínima significación clínica, sugiere que ambas intervenciones son similares respecto a los eventos adversos, consistente con las recomendaciones actuales de las pautas clínicas.,Las guías de la “American Association Respiratory Care” (AARC) para la práctica de la AE en pacientes con ventilación mecánica y vía aérea artificial recomiendan que se debe evitar la AE de rutinaria, apoyándose en los resultados de tres ensayos clínicos, sin embargo uno fue realizado en adultos ,,Existen varios estudios observacionales en la población pediátrica, que han descrito la incidencia de eventos adversos asociados a la práctica de la AE, los cuales fueron revisados recientemente La ausencia de extubación accidental durante la práctica de la AE en este estudio difiere de lo reportado en los trabajos, donde la práctica de procedimientos como la AE fue descrita como uno de los factores de riesgo para la extubación accidental y se ha descrito que la manipulación para la AE al momento de la extubación no planeada en la UCI neonatal fluctúa entre el 17% y 30% de todos los pacientes que tuvieron extubaciones no planeadas Algunos autores han descrito incremento en los días de ventilación mecánica y estancia en la UCIP como consecuencia de la extubación accidental No hubo esfuerzos adicionales ni necesidad de que más personal para practicar el protocolo a necesidad. Utilizando este protocolo, el tiempo entre las aspiraciones se duplicó. El tiempo liberado fue utilizando para proporcionar otros cuidados que den más beneficios para los pacientes. Sin embargo, este resultado no se midió objetivamente teniendo en cuenta que no era el objetivo del estudio.Una de las limitaciones para este trabajo fue la baja frecuencia del desenlace primario, menor que el estimado de esos reportes de la literatura, lo cual afectó el poder del estudio, sin embargo, la diferencia encontrada entre los dos grupos es muy pequeña y también fue menor que la estimada de los estudios observacionales, por lo que se considera plausible aceptar que la falta de detección de diferencias significativas en la frecuencia de desenlaces entre los dos los grupos no se debió a la disminución del poder del estudio. Una segunda limitación fue la falta de cegamiento, que es imposible evitar considerando el tipo de intervención implementada, pero se trató de controlar evaluando el resultado por el personal independiente del equipo de investigación e indirectamente evaluando la posibilidad de que este conocimiento induciría otra las co-intervenciones diferenciales, que no aparecieron. También hubo dificultad para definir de manera objetiva los componentes del desenlace principal.Una revisión Cochrane reciente de la frecuencia de aspiración endotraqueal para la prevención de la morbilidad respiratoria en recién nacidos ventilados, encuentró que la frecuencia ideal de la AE se ha investigado en pocos estudios, identificó sólo un estudio aleatorio controlado de 1991 para incluir en la revisión y concluye que no hubo suficiente evidencia para identificar la frecuencia ideal de la AE en neonatos ventilados.