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临床试验/NCT07662642
NCT07662642招募中不适用

Comparison of the Effects of Recruitment Maneuver Timing on Postoperative Pulmonary Complications in Patients Undergoing Robotic Prostate Surgery

Ankara University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2026年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
86
试验地点
1

研究概览

简要总结

Robotic prostate surgery is commonly performed under general anesthesia with carbon dioxide pneumoperitoneum and steep Trendelenburg positioning. These conditions may reduce lung volumes, impair respiratory mechanics, and increase the risk of atelectasis and postoperative pulmonary complications. Recruitment maneuvers combined with individualized positive end-expiratory pressure may improve intraoperative oxygenation and lung compliance; however, the optimal timing of recruitment maneuver application in robotic prostate surgery remains unclear.

This prospective randomized study aims to compare the effects of recruitment maneuver timing on postoperative pulmonary complications in adult patients undergoing elective robotic prostate surgery. Participants will be randomized into two groups. In the Supine Recruitment Group, the recruitment maneuver will be performed before carbon dioxide insufflation while the patient is in the supine position, followed by individualized PEEP determination. In the Trendelenburg Recruitment Group, the recruitment maneuver will be performed after pneumoperitoneum and Trendelenburg positioning, followed by individualized PEEP determination. Patients will be evaluated for postoperative pulmonary complications up to postoperative 72 hours or until discharge, whichever occurs first.

详细描述

Laparoscopic and robotic surgeries performed with carbon dioxide insufflation may cause clinically relevant physiological changes affecting pulmonary function. Pneumoperitoneum increases intra-abdominal pressure and, together with Trendelenburg positioning, may reduce functional residual capacity, decrease lung compliance, and promote atelectasis. These changes may contribute to hypoxemia and postoperative pulmonary complications.

Recruitment maneuvers are used to reopen collapsed alveolar units and may improve oxygenation and respiratory mechanics when combined with appropriate PEEP. Decremental PEEP titration is one method used to determine an individualized PEEP level after a recruitment maneuver by gradually reducing PEEP while monitoring oxygenation, respiratory compliance, and hemodynamic parameters.

The present study will evaluate whether the timing of recruitment maneuver application affects postoperative pulmonary outcomes in patients undergoing robotic prostate surgery. The study will compare recruitment maneuver performed before insufflation in the supine position with recruitment maneuver performed after insufflation and Trendelenburg positioning. Both groups will undergo individualized PEEP determination after the recruitment maneuver.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

Participants and outcome assessors were masked to group allocation. The anesthesiologist performing the recruitment maneuver was not masked because of the nature of the intervention.

入排标准

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

入选标准

  • Patients scheduled for elective robotic prostate surgery
  • Age 18 years or older
  • Body mass index between 18 and 35 kg/m²
  • No cognitive impairment
  • Ability to provide written informed consent

排除标准

  • Age younger than 18 years
  • Emergency surgery
  • Preoperative oxygen requirement
  • Cognitive impairment
  • Refusal to participate in the study

研究者

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

CIGDEM YILDIRIM GUCLU

Principal Investigator

Ankara University

研究点 (1)

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