1. 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
- Author
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Serge Molliex, Bruno Pereira, Emmanuel Futier, Florence Rancon, Marlène Bonnefoi, Sylvie Passot, and Yannick LeManach
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,Population ,030204 cardiovascular system & hematology ,Anesthesia, General ,anesthesia ,Disease cluster ,hemodynamics ,Anaesthesia ,03 medical and health sciences ,Femoral head ,0302 clinical medicine ,Postoperative Complications ,030202 anesthesiology ,Informed consent ,Risk Factors ,stepped wedge cluster trail ,Protocol ,Medicine ,Cluster Analysis ,Humans ,Multicenter Studies as Topic ,General anaesthesia ,Cluster randomised controlled trial ,Prospective Studies ,education ,Case report form ,Aged ,Randomized Controlled Trials as Topic ,Protocol (science) ,Aged, 80 and over ,education.field_of_study ,business.industry ,ventilation ,General Medicine ,Survival Analysis ,monitoring, intraoperative ,medicine.anatomical_structure ,age ,Elective Surgical Procedures ,Emergency medicine ,Female ,Morbidity ,business - Abstract
IntroductionElderly 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.AimsThe 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 analysisThis 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 disseminationThis 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 conferencesTrial registration numberNCT02668250
- Published
- 2018