Stepped wedge cluster randomised controlled trial to assess the effectiveness of an optimisation strategy for general anaesthesia on postoperative morbidity and mortality in elderly patients (the OPTI-AGED study): a study protocol.
INTRODUCTION
Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In adult patients, several specific intraoperative approaches such as cardiac output-guided haemodynamic therapy, depth of anaesthesia monitoring (DAM) or lung-protective ventilation (LPV) are designed to reduce postoperative mortality and surgical complications. However, none of these approaches has been specifically performed in the elderly, and no evaluation of a multimodal optimisation strategy for general anaesthesia has been achieved in this population.


AIMS
The objective of this study is to assess, in high-risk patients aged 75 years and over undergoing high-risk surgery, the effectiveness of combined optimisation of anaesthesia involving goal-directed haemodynamic therapy (GDHT), LPV and electroencephalographic DAM on postoperative morbidity and mortality. The primary outcome of the study is a composite criterion associating major postoperative complications and mortality occurring within the 30 first postoperative days. The secondary outcomes are 1-year postoperative autonomy and mortality.


METHODS AND ANALYSIS
This prospective, randomised, controlled, multicentre trial using a stepped wedge cluster design will be conducted in 27 French university centres. Patients aged 75 years and over, undergoing femoral head fractures and major intraperitoneal or vascular elective surgeries will be included after informed consent. They will benefit from usual care in the 'control group' and from a combined optimisation of general anaesthesia involving GDHT, LPV and DAM in the 'optimisation group'. The cluster's crossover will be unidirectional, from control to optimisation, and randomised. Data will be recorded at inclusion, the day of surgery, 7 days, 30 days and 1year postoperatively and collected into a hosted electronic case report form. The primary outcome of the study is a composite criterion associating major postoperative complications and mortality occurring within the 30 first postoperative days. The secondary outcomes are 1- year postoperative autonomy and mortality.


ETHICS AND DISSEMINATION
This protocol was approved by the ethics committee Sud-Est 1 and the French regulatory agency. The finding of the trial will be disseminated through peer-reviewed journals and conferences TRIAL REGISTRATION NUMBER: NCT02668250; Pre-results.
['Molliex|Serge|S|', 'Passot|Sylvie|S|', 'Futier|Emmanuel|E|', 'Bonnefoi|Marlène|M|', 'Rancon|Florence|F|', 'Lemanach|Yannick|Y|', 'Pereira|Bruno|B|']
D000368:Aged D000369:Aged, 80 and over D000768:Anesthesia, General D016000:Cluster Analysis D017558:Elective Surgical Procedures D005260:Female D006439:Hemodynamics D006801:Humans D008297:Male D009017:Morbidity D015337:Multicenter Studies as Topic D011183:Postoperative Complications D011446:Prospective Studies D016032:Randomized Controlled Trials as Topic D012307:Risk Factors D016019:Survival Analysis D013997:Time Factors
ventilation age anesthesia hemodynamics monitoring, intraoperative stepped wedge cluster trail