跳至主要内容
临床试验/CTRI/2024/07/071479
CTRI/2024/07/071479尚未招募不适用

Comparison of peak inspiratory pressure and dynamic compliance between ambu auragain laryngeal mask airway and endotracheal tube

Dayanand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年8月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Change in peak inspiratory pressure and dynamic compliance with the use of either Ambu AuraGain or endotracheal tube .

研究概览

简要总结

Respiratory mechanics are significantly altered in patients who are undergoing laparoscopic surgeries. Pneumoperitoneum created during laparoscopic cholecystectomy alters respiratory system mechanics which may be deleterious in patients with compromised pulmonary function. Therefore a proper choice and use of airway device whether Ambu AuraGain laryngeal mask airway or endotracheal tube can help avoid respiratory and haemodynamic complications. A prospective, randomised, interventional study will be conducted on 70 ASA I,II and III patients undergoing elective laparoscopic cholecystectomy under general anaesthesia. Enrolled patients will be randomly allocated into two groups. In Group A, Ambu AuraGain will be inserted while in Group E, endotracheal tube will be inserted. Peak inspiratory pressure, dynamic compliance ,haemodynamic parameters, ease of insertion of airway device and post operative complications  with the use of airway device  will be noted in both the groups.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adults of either gender
  • Age between 18 to 65 years
  • Patients undergoing elective laparoscopic cholecystectomy
  • American Society of Anaesthesiologists Physical Status (ASA) I, II and III patients
  • BMI less than 35 kg/m2.

排除标准

  • Anticipated anatomical or physiological difficult airway
  • Pregnant patients
  • Presence of significant acute or chronic lung disease
  • Patient refusal to participate in study.

结局指标

主要结局

Change in peak inspiratory pressure and dynamic compliance with the use of either Ambu AuraGain or endotracheal tube .

时间窗: Patients will be observed at baseline after induction of anaesthesia , 5 minutes after positioning of patient and before pneumoperitoneum , 5 minutes post pneumoperitoneum creation ,10 minutes post pneumoperitoneum and then every 10 minutes upto 180 minutes after induction of anaesthesia

次要结局

  • Change in haemodynamic parameters ,ease of insertion of airway device & post operative complications if any with the use of airway device whether Ambu AuraGain or endotracheal tube.(Patients will be observed at baseline, immediately after insertion, at 5 minutes,10 minutes,20 minutes,30 minutes & then every 15 minutes upto 180 minutes after induction of anaesthesia.Post operative complications will be recorded till the discharge of the patient from the post anaesthesia care unit.)

研究者

发起方
Dayanand Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Kamakshi Garg

Dayanand Medical College and Hospital

研究点 (1)

Loading locations...

相似试验