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Abstract
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.
- age
- anesthesia
- monitoring, intraoperative
- hemodynamics
- ventilation
- stepped wedge cluster trail
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Footnotes
Contributors All authors made substantial contributions to the OPTI-AGED trial and gave final approval of the manuscript. SM drafted the manuscript with SP and BP. SM designed the study together with EF and YL. Trial design refinement and sample size calculation were determined by YL and BP. BP planned the statistical analysis. SM is the principal investigator and coordinator of OPTI-AGED. SM, SP, EF, YL and BP are members of the steering and trial management committee. MB and FR are members of the trial management committee.
Funding The OPTI-AGED trial is funded by the French Ministry of Health (Ministère des Solidarités et de la Santé) through the National Clinical Research Program (Programme Hospitalier de Recherche Clinique National).
Competing interests SM had financial support for the submitted work from the French Ministry of Health and is consultant for Baxter SA. EF is consultant for Drager Medical and Edwards SA and received travel funding for lectures from Drager Medical, GE Healthcare, Fresenius Kabi, Baxter SA and Edwards SA . YL is consultant and received travel funding for lectures from Edwards SA.
Patient consent Obtained.
Ethics approval The study was approved for all coinvestigator centres by the institutional review board of Saint-Etienne University Hospital, as well as the regional ethics committee (‘Comité de Protection des Personnes Sud-Est 1’) on 13 June 2016 with registration number 2016–24.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Not applicable; our manuscript is a study protocol.