跳至主要内容
临床试验/NCT04802421
NCT04802421Unknown不适用

Hemodynamic Effect of Alveolar Recruitment Manoeuver Through Stepwise Increase and Decrease in Irway Pressure or Sustained 30 Secondes 30 cmH2O Continuous Positive Airway Pressure. A Randomized Study.

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年3月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
cardiac stroke volume

研究概览

简要总结

Objective: to compare the effect of alveolar recruitment manouver through stepwise increase and decrease in airway pressure or sustained 30 secondes 30 cmH2O continuous positive airway pressure on cardiac stroke volume estimated by oesophageal doppler in preload independent anesthetized patients scheduled for surgery.

详细描述

Following anesthesia and preload optimisation guided by cardiac stroke volume, patients will be randomised to one alveolr recruitment manoeuver :

  • stepwise increase and decrease in positive airway pressure
  • sustained 30 secondes 30 cmH2O continuous positive airway pressure The primary objective is the change in cardiac stroke volume.

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
Double (Participant, Care Provider)

盲法说明

The patient will not know the allocation group because he will be anesthetised before randomisation. The care provider (anesthetist) will not know the allocation group because the intervention will be applied by an independent investigator not involved in care of the patient.

入排标准

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

入选标准

  • •adult patients scheduled for major surgery requiring hemodynamic monitoring
  • •written signed informed consent

排除标准

  • •pregnancy
  • •non sinusal heart rate
  • •known cardiac right ventricular failure or arterial pulmonary hypertension
  • •pneumothorax
  • •known pulmonary emphysema

研究组 & 干预措施

CPAP30

Active Comparator

a 30 secondes 30 cmH2O continuous positive airway pressure applied after the orotracheal intubation will be checked and secured following induction of general anesthesia

干预措施: alveolar recruitment manoeuver (Procedure)

STEP30

Active Comparator

a stepwise increase (+5 cmH2O) in postivie airway pressure from +5 cmH2O to +30 cmH2O and decrease (-5 cmH2O) from +30 cmH2O to +5 cmH2O applied after the orotracheal intubation will be checked and secured following induction of general anesthesia

干预措施: alveolar recruitment manoeuver (Procedure)

结局指标

主要结局

cardiac stroke volume

时间窗: 1 min

change in cardiac stroke volume during the alveolar recruitment manoeuver

次要结局

  • arterial pressure(1 min)
  • recovery at 3 min(3 min)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Effect Alveolar Recruitment Manoeuver on Stroke... | 临床试验