Tolerability and performance of XXXX endotracheal tubes with noble metal alloy coating - a randomized clinical evaluation study.

@entity1 @entity1477 @entity575 @entity2133 @entity16 @entity11720 @entity1729
BACKGROUND: Hospital acquired infections worsen the outcome of @entity1 treated in intensive care units and are costly. Coatings with @entity575 or metal alloys may reduce or alter the formation of biofilm on invasive medical devices. An endotracheal tube (ETT) is used to connect the @entity1 to a ventilator and coated tubes have been tested in relation to bacterial colonization and @entity1729 . In the present study, we aimed to evaluate and compare a coated and uncoated ETT for @entity1 symptoms and local tracheal tolerability during short term clinical use. Degree of bacterial colonization was also described. METHODS: A @entity575 - @entity11720 -gold alloy coating ('Bactiguard  'Infection Protection, @entity1477 ) has been extensively used on urinary tract catheters and lately also on central venous catheters. We performed a randomised, single-blinded, controlled, first in @entity1 , post Conformit   Europ  enne (EC) certification and CE marking study, focused on Bactiguard   coated ETTs ( @entity1477 ETT). Thirty @entity1 at a tertiary university hospital scheduled for upper abdominal elective surgery with an expected duration of anaesthesia of at least 3  h were randomised; @entity1477 ETT (n   =   20) or standard ETT (n   =   10). The tolerability was assessed with a modified version of Quality of Life Head and Neck Module, QLQ-H_N35 and by inspection of the tracheal mucosa with a fibre-optic bronchoscope before intubation and at extubation. Adverse Events (AE) and bacterial adherence were also studied. Statistical evaluations were carried out with the Fisher's Exact Test, the Clopper-Pearson method, as well as a Proportional Odds Model. RESULTS: Differences between groups were identified in 2 of 8 @entity1 related symptoms with regard to tolerability by QLQ-H_N35 (cough, p   =   0.022 and @entity2133 , p   =   0.014 in the treatment group.). No @entity16 was identified with bronchoscopy. A low level of bacterial colonization with normal flora, equal between groups, was seen after short-term of intubation (median 5  h). No serious Adverse Events related to the use of an ETT were observed. The results should be treated with caution due to statistical confounders, a small study size and large inter-individual variability in bacterial adhesion. CONCLUSIONS: The new device @entity1477 ETT is well tolerated and has good clinical performance during short-term intubation. Studies with larger sample sizes and longer intubation periods (>24  h) in the ICU-setting are needed and can now be planned in order to identify possible differences in clinical outcomes. TRIAL REGISTRATION: Registered in ClinicalTrials.gov, REGISTRATION NUMBER: NCT01682486 , Date of Registration: August, 30, 2012.
