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临床试验/NCT03868319
NCT03868319已完成不适用

Effect of Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy on Postoperative Pulmonary Complication

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
258
试验地点
1
主要终点
occurrence of postoperative pulmonary complications (PPCs)

研究概览

简要总结

Robot-assisted laparoscopic radical cystectomy (RARC) increases the incidence of postoperative complications. We conducted a study to determine the effect of lung-protective ventilation strategy.

详细描述

Robot-assisted laparoscopic radical cystectomy (RARC) performed with patient in the steep Trendelenburg position under pneumoperitoneum increases the incidence of postoperative complications. Approach termed lung-protective ventilation (LPV) strategy which refers to the use of low tidal volumes and positive end-expiratory pressure (PEEP) may lead to a reduction in inflammation and prevent the occurrence of atelectasis. Computed tomography (CT) requiring transportation is the golden standard for measuring atelectasis, which is not suitable for perioperative observation. Lung ultrasound (LUS) which is noninvasive and easily repeatable at the bedside appears to be an accurate diagnostic tool for early detection of atelectasis. Thus, we conducted the trial to determine whether an LPV strategy has benefits in patients scheduled for RARC through a multifaceted method. We hypothesized that the use of prophylactic low tidal volume and PEEP would decrease postoperative inflammation and atelectasis, thereby, improve outcomes, as compared with the standard of nonprotective mechanical ventilation.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Investigators, surgeons and patients remained unware of study-group assignments so as to preserve the double blinding.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled for elective RARC

排除标准

  • history of lung surgery
  • patients' refusal or inability to give informed consent

研究组 & 干预措施

control group

Experimental

nonprotective ventilation with a tidal volume of 9 ml kg-1 PBW with ZEEP

干预措施: nonprotective ventilation (Procedure)

LPV group

Experimental

a tidal volume of 6 ml kg-1 PBW with a 7 cmH2O level PEEP

干预措施: lung protective ventilation strategy (Procedure)

结局指标

主要结局

occurrence of postoperative pulmonary complications (PPCs)

时间窗: during the first 90 days after surgery

graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications)

次要结局

未报告次要终点

研究者

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

DAN HUANG

Principal Investigator, clinical attending in anesthesia department

RenJi Hospital

研究点 (1)

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