跳至主要内容
临床试验/CTRI/2018/06/014648
CTRI/2018/06/014648招募中4 期

Comparative study to evaluate the effect of degree of Trendelenburg position on the respiratory dynamics with pressure controlled volume guaranteed ventilation during laparoscopic surgeries in obese and non obese patients

Dr L H Hiranandani Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年2月26日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
100
试验地点
1
主要终点
To evaluate and compare the effect of pneumoperitoneum in obese and non-obese patients on the respiratory dynamics like peak inspiratory pressure, mean airway pressure and the dynamic compliance of the lungs during laparoscopic surgeries with different degree of Trendelenburg position.

研究概览

简要总结

This study is designed to evaluate and compare the effect of degree of Trendelenburg tilt on the respiratory dynamics and the haemodynamics during laprascopic abdominal surgeries and to see the effect of obesity on these parameters

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with ASA 1 and 2
  • Duration of anaesthesia lasting form 30 minutes up to 240 minutes
  • Age 18 to 70 years
  • Weight > 40kgs
  • Patients giving valid written consent
  • BMI 18.5 and £ 40.

排除标准

  • Patient refusal to be included in the study
  • Patients with cardio-respiratory disease
  • EtCO2 ³ 50 preoperatively
  • Saturation £ 90 % on room air preoperatively
  • Chronic heavy smoker
  • Chronic alcoholics
  • Patients with neuromuscular disorder
  • Conversion of laparoscopic surgery to open surgery at any point in time.

结局指标

主要结局

To evaluate and compare the effect of pneumoperitoneum in obese and non-obese patients on the respiratory dynamics like peak inspiratory pressure, mean airway pressure and the dynamic compliance of the lungs during laparoscopic surgeries with different degree of Trendelenburg position.

时间窗: To evaluate and compare the effect of pneumoperitoneum in obese and non-obese patients on the respiratory dynamics like peak inspiratory pressure, mean airway pressure and the dynamic compliance of the lungs during laparoscopic surgeries in supine position and with different degree of Trendelenburg position 5, 10,15 and 20 degree with and without pneumoperitoneum intraoperatively during the surgery

次要结局

  • 1. To assess the changes in hemodynamic parameters during laparoscopic surgeries in different degree of Trendelenburg position in obese and non-obese patients.(2. To assess the ideal degree of angulation for best visualization of operating field with the least effect on the respiratory and hemodynamic parameters.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验