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临床试验/CTRI/2025/07/090398
CTRI/2025/07/090398尚未招募不适用

A Randomised study to compare the Endotracheal tube cuff pressure during laparoscopic and open surgery

Government of Gujarat1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
To compare changes in ETT cuff pressure in laparoscopic and open abdominal surgeries.

研究概览

简要总结

Endotracheal Tube is the preferred airway device for almost all complex  general anaesthesia cases.The Endotracheal tube cuff is a device that protect the lung from aspiration of gastric contents, blood, secretions, and other fluid s & facilitating positive pressure ventilation.Normal cuff pressure should be between 20 -30 cm H2O, cuff pressure above 30 cm H2O obstructs the tracheal wall blood flow.

Nowadays,Laparoscopic surgeries are gaining popularity because of a smaller incision,decreased pain, faster ambulation and short hospital stay.For laparoscopic surgeries general

anaesthesia with cuffed Endotracheal tube intubation and controlled ventilation remains the safe technique of anaesthsia.

However increase endotracheal tube cuff pressure resulting from pneumoperitoneum may raise the risk of cough, sorethroat, hoarseness and blood streaked expectoration.In addition, Factors

such as position of patient head and neck, tredelenburg position, Duration of ETT placement, cuff volume ,use of nitrous oxide and degree of neuromuscular blockage affects ETT cuff pressure .

Very few studies on ETT cuff pressure changes in open abdominal surgery has been done.This

study is planned to evaluate ETT cuff p ressure changes during laparoscopic and open abdominal surgeries,the correlation  between pneumoperitoneum time, head up and head down position with changes in cuff pressure and POST.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Patients willing to consent for the study
  • Age :18 to 65 years( BMI- 18 to 35)
  • Either gender
  • American Society of Anesthesiologist (ASA) Classification I, II, III
  • Elective Surgery.

排除标准

  • Patients with anticipated difficult Intubation , history of Tracheostomy.
  • Patients with pre-existing uncompensated Lung and cardiac illness.
  • Pregnant patients.
  • Patient refusal to give consent.

结局指标

主要结局

To compare changes in ETT cuff pressure in laparoscopic and open abdominal surgeries.

时间窗: Every 15minutes intraperatively, followed by 3,6,9,12,18,24hours

次要结局

  • 1.To co rre late E TT c uff pressure c hange s in head up and head d ow n position.(2. To correlate ETT cuff pressure changes and POST, difficulty in Swallowing and)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shadab Mohammad gulhasan khan

BJ Medical College, Ahmedabad

研究点 (1)

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