跳至主要内容
临床试验/NCT06909630
NCT06909630已完成不适用

Effects of Individualized PEEP Using Driving Pressure Ventilation on Postoperative Lung Complications in Robot Prostatectomy Surgery: Prospective Randomized Clinical Trial

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2023年1月6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
128
试验地点
1
主要终点
Post operative pulmonary complication(PPC)

研究概览

简要总结

In the case of robotic prostate cancer surgery under general anesthesia, the surgical posture is extreme Trendelenburg. Therefore, airway pressure is very high during mechanical ventilation, and there is a possibility of postoperative pulmonary complications. In order to prevent postoperative pulmonary complications, we tried to apply end-tidal pressure suitable for each individual to set the most tidal volume that can reduce the burden on the lungs during the perioperative period.

详细描述

This study is conducted on patients who are scheduled for prostate surgery under general anesthesia with robot assistance. Subjects who consented to the consent form the day before the surgery were conducted with people aged 19 years or older who belonged to the American Society of Anesthesiologists (ASA) class I or II. In the drive group, the ventilator setting is fixed at tidal volume 6-8ml/kg and respiratory rate 15 breathes/min, and then the recruitment maneuver (RM, alveolar recruitment) is performed within the range that does not cause hemodynamic instability. After that, the PEEP is gradually raised from 5 cmH2O to 20 cmH2O. Driving pressure finds the lowest value. If there is no significant change even when the pressure change raises the PEEP, select the lowest PEEP. In the control group, PEEP is maintained in 5 cmH2O until the end of surgery. The primary outcome of the study is to confirm the presence or absence of postoperative pulmonary complications using Chest X-rays, vital signs, and blood tests. It is the individualized PEEP value as a secondary outcome. The related driving pressure and compliance will also be observed. In addition, anesthesia/surgical time, use of vasopressors, amount of blood loss, amount of fluid, and amount of urine will be measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Because a table of random numbers is used, participants do not know which group they belong to.

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •elective RALP surgery under genenal anesthesia
  • •19 years of age or older
  • •Consented to participate in the study

排除标准

  • •Do not consent to participate in the study
  • •≥ BMI 40 kg/m2
  • •Moderate or severe obstructive/restrictive pulmonary disease on pulmonary function tests
  • •Preoperative serious cardiovascular disease
  • •Required postoperative ventilator care at ICU care

研究组 & 干预措施

Control group

No Intervention

PEEP is maintained in 5 cmH2O until the end of surgery.

Driving pressure group

Experimental

Individual PEEP is applied according to the driving pressure.

干预措施: Driving pressure group (Other)

结局指标

主要结局

Post operative pulmonary complication(PPC)

时间窗: up to PostOperative Day(POD) #3

Post operative lung complication

次要结局

  • Individual ventilatory setting(during opertaion)
  • blood pressure(hypotension)(during opertaion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Individualized PEEP and Driving Pressure Ventilation... | 临床试验