跳至主要内容
临床试验/NCT05713929
NCT05713929Unknown不适用

Study of Atelectasis by Electrical Impedance Tomography and the Effects of Different Positions on Their Occurrence, Reversibility and Regional Distribution, During General Anesthesia

Erasme University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
the percentage of atelectasis after induction of general anesthesia (Time 1)

研究概览

简要总结

The goal of this interventional study is to learn about the effects of different positions on the occurrence, regional distribution and reversibility of atelectasis by using a PulmoVista 500 monitor (Dräger. 23542 Lübeck), during general anesthesia with mechanical ventilation.

The main questions it aims to answer are:

  • The increase in atelectasis after induction of general anesthesia in supine and Trendelenburg position compared with baseline (spontaneous breathing)
  • The eventual possibility of reversal of atelectasis caused by general anesthesia and Trendelenburg position by reverse Trendelenburg position and recruitment manœuvre.

Participants will be adult, autonomous and able to express their will, undergoing elective gynecological or urological surgery in the extended Trendelenburg position.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult subjects over eighteen years old;
  • Requiring laparoscopic gynecological, urological or digestive surgery;
  • Surgery requiring Trendelenburg position and tracheal intubation.

排除标准

  • Emergency operation;
  • Thoracic surgery;
  • Pulmonary, cardiac pathology;
  • Pregnant woman;
  • BMI > 30;
  • Comorbidities defined as an American Society of Anesthesiologists physical condition greater than 2;
  • Language barrier;
  • Refusal of consent.

结局指标

主要结局

the percentage of atelectasis after induction of general anesthesia (Time 1)

时间窗: from the base measure to time 1 (10 minutes)

percentage

the percentage of atelectasis after being positioned in the trendelenburg position (Time 2)

时间窗: from the base measure to time 2 (15 minutes)

percentage

次要结局

  • The eventual possibility of reversal of atelectasis by reverse Trendelenburg position and recruitment maneuver (Time 3)(from the base measure to time 3 (20 minutes))

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验