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

Serge Molliex, Sylvie Passot, Emmanuel Futier, Marlène Bonnefoi, Florence Rancon, Yannick Lemanach, Bruno Pereira, Serge Molliex, Sylvie Passot, Emmanuel Futier, Marlène Bonnefoi, Florence Rancon, Yannick Lemanach, Bruno Pereira

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.

Keywords: age; anesthesia; hemodynamics; monitoring, intraoperative; stepped wedge cluster trail; ventilation.

Conflict of interest statement

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.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
CONSORT flow chart illustrating the randomisation and flow of patients in the study. CONSORT, Consolidated Standards of Reporting Trials.
Figure 2
Figure 2
Algorithm for goal-directed haemodynamic therapy. SV, stroke volume.
Figure 3
Figure 3
Trial flow chart.

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