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临床试验/CTRI/2026/04/108844
CTRI/2026/04/108844尚未招募不适用

Comparison of Individualised PEEP Using Lung Compliance versus Body Mass Index in Laproscopic Gynaecological surgery: A Randomized Controlled Trial

All India institute of medical sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1

研究概览

简要总结

This randomized controlled trial will compare individualized positive end-expiratory pressure (PEEP) titrated using lung compliance with BMI-based PEEP during elective laparoscopic gynaecological surgery under general anaesthesia. Laparoscopic procedures with pneumoperitoneum and Trendelenburg positioning impair respiratory mechanics and may increase driving pressure atelectasis, and postoperative pulmonary complications. There is currently no consensus on the optimal method to select intraoperative PEEP.

A total of 60 adult female patients will be randomized into two groups. Group C will receive individualized PEEP identified by an incremental–decremental PEEP titration aimed at achieving the lowest driving pressure. Group B will receive BMI-based PEEP. Standardized anaesthesia, ventilation settings, and intraoperative monitoring will be used for all participants.

The primary outcome is mean intraoperative driving pressure. Secondary outcomes include respiratory compliance lung aeration measured by Lung Ultrasound Score oxygenation parameters  haemodynamic stability, and incidence of postoperative pulmonary complications. The study aims to determine whether compliance-guided individualized PEEP improves intraoperative respiratory mechanics and postoperative lung aeration compared to BMI-based PEEP

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • ASA Physical Status I or II or III BMI
  • 40 Kg/m2 Scheduled for elective laparoscopic gynecological surgery under general anaesthesia. Informed consent.

排除标准

  • Pre- existing lung disease (COPD, ARDS, fibrosis) Pregnancy Emergency or open surgery MAP less than 65 mmHg or need for vasopressors prior to induction Contraindication to PEEP ( eg., pneumothorax, severe pulmonary hypertension) Refusal or inability to provide informed consent.

研究者

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

Dr Sakshi Duggal

All India institute of medical sciences, New Delhi

研究点 (1)

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