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
Bibliographic record
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.012 | 0.012 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.017 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".