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临床试验/NCT05781373
NCT05781373尚未招募不适用

Effect of Intraoperative PEEP Individualization According to Driving Pressure in Major Abdominal Surgery

Mongi Slim Hospital0 个研究点目标入组 100 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
incidence of pulmonary post operative complications

研究概览

简要总结

In this prospective, randomized trial, including patients scheduled for a major open or laparoscopic abdominal surgery (duration >2 hours) under general anesthesia , the investigators will compare 2 strategies of protective mechanical ventilation: a fixed intraoperative PEEP of 6 cmH2O and an individualized intraoperative PEEP according to the driving pressure.

详细描述

Patients will be randomized into 2 groups:

  • Fixed PEEP group: will receive protective intraoperative mechanical ventilation: tidal volume: 6 ml/kg of PBW, recruitment maneuvers every immediately after tracheal intubation and every 2 hours and a fixed PEEP of 6 cmH2O
  • Individualized PEEP: protective mechanical ventilation with the same modality with an individualization of PEEP levels hourly in order to achieve the lowest driving pressure. PEEP levels will be adjusted after intubation and hourly by increasing or decreasing PEEP levels every 10 respiratory cycles.

The primary outcome: incidence of post operative pulmonary complications during the first post operative days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

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

  • BMI<35, ARISCAT score > 26, patients scheduled for major abdominal surgery

排除标准

  • unplanned post operative ICU stay and mechanical ventilation

结局指标

主要结局

incidence of pulmonary post operative complications

时间窗: first 7 post operative days

SpO2\< 92%, new chest Xray infiltrates, acute respiratory failure requiring intervention

次要结局

  • lung aeration score (LAS)(day 1, day 3 and day 7 after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mhamed Sami Mebazaa

Professor head of anesthesia and intensive care department

Mongi Slim Hospital

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