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临床试验/NCT05886387
NCT05886387已完成不适用

Effect of Intraoperative PEEP With Recruitment Manoeuvres on the Occurrence of Postoperative Pulmonary Complications During General Anaesthesia--a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation

Instituto de Investigacion Sanitaria La Fe4 个研究点 分布在 4 个国家目标入组 3,836 人开始时间: 2022年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,836
试验地点
4
主要终点
Incidence of postoperative pulmonary complications

研究概览

简要总结

The investigators designed a protocol for a Bayesian unplanned posthoc analysis using the pooled dataset from three large randomized clinical trials. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators will carry out a reanalysis of the harmonised database using Bayesian statistics.

详细描述

Background: Using the frequentist approach, a recent meta-analysis of three randomized clinical trials in patients undergoing intraoperative ventilation during general anesthesia for major surgery. failed to show the benefit of ventilation that uses high positive end expiratory pressure with recruitment maneuvers when compared to ventilation that uses low positive end-expiratory pressure without recruitment maneuvers.

Methods: The investigators designed a protocol for a Bayesian analysis using the pooled dataset. The multilevel Bayesian logistic model will use the individual patient data. Prior distributions will be prespecified to represent a varying level of skepticism for the effect estimate. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators preset a range of practical equivalence to assess the futility of the intervention with an interval of odds ratio (OR) between 0.9 and 1.1 and assess how much of the 95% of highest density interval (HDI) falls between the region of practical equivalence.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Planned for major surgery
  • At risk for pulmonary complications

排除标准

  • Planned thoracic surgery .
  • Unscheduled surgery (i.e., urgent, or emergent surgeries)

结局指标

主要结局

Incidence of postoperative pulmonary complications

时间窗: Until day seven or hospital discharge, whichever comes first ]

次要结局

未报告次要终点

研究者

发起方
Instituto de Investigacion Sanitaria La Fe
申办方类型
Other
责任方
Sponsor

研究点 (4)

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