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临床试验/CTRI/2026/03/105790
CTRI/2026/03/105790尚未招募不适用

A prospective randomized observational study to compare the tracheal cuff inflation method guided by pressure volume loop closure versus manometer in a supine position.

Seth GSMC and KEM Hospital Parel Mumbai Maharashtra India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To compare the volume of air used to inflate the tracheal cuff using method guided by pressure volume loop closure versus manometer in a supine position.

研究概览

简要总结

Cuffed endotracheal tube is widely used for general anesthesia and is popularly known to maintain adequate sealing of airway against  gastro-pharyngeal aspiration along with adequate lung ventilation. It provides better seal for trachea. Pressure inside the cuff should be adequate enough to seal the trachea against but simultaneously care should be taken that the pressure should not be too high to cause harmful effects on trachea with pressure changes such as tracheal ischemia, nerve palsies, or post op complications such as sore throat, hoarsness or dysphagia. Hence, as a researcher our aim should be to find out the best method to measure the volume of air that is required to inflate the cuff.  Although manometer is considered as the gold standard and it is said that the pressure should be around 20-30 cm of h20 in manometer to achieve adequate sealing of cuff, it might not be available in every periphery or limited resources places. Hence the goal is to compare the amount of volume required to inflate the cuff by pressure volume loop closure method and manometer and to compare the post operative complications such as hoarsness and sorethroat.

研究设计

研究类型
Observational

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 whose age group is between 18 and 65years.
  • •ASA grade 1 & ASA grade 2 patients.

排除标准

  • •pregnant pateint emergency cases history of urti/lrti with in last 15 days pateint with thyroid swelling,tracheal pathologies bmi more than 30 kg/m2.

结局指标

主要结局

To compare the volume of air used to inflate the tracheal cuff using method guided by pressure volume loop closure versus manometer in a supine position.

时间窗: Post operative 2 hours

次要结局

  • To compare the incidence of sore throat and hoarsness in both the methods.(Post operative period.)

研究者

发起方
Seth GSMC and KEM Hospital Parel Mumbai Maharashtra India
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shrikanta Oak

Seth G.S. Medical college and KEM hospital

研究点 (1)

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