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临床试验/CTRI/2023/06/054077
CTRI/2023/06/054077尚未招募1 期

comparison of three endotracheal tube cuff inflation techniques to obtain recommended endotracheal tube cuff pressure in adult patients undergoing general anaesthesia with endotracheal intubation

Dr Suman Saini1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年6月30日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
to compare the accuracy of three different techniques using pressure value in the endotracheal tube cuff immediately following inflation in adult patients undergoing general anaesthesia with endotracheal intubation

研究概览

简要总结

endotracheal intubation is routinely performed for patients undergoing general anaesthesia.it is crucial to maintain appropriate cuff pressure to avoid cuff related serious adverse events. under inflation may lead to gastric distension, aspiration of oropharyngeal secretions, leakage of anaesthetic gases and thereby environmental pollution. overinflation may lead to compromised local tissue blood flow, necrosis and damage to surrounding anatomical structures. recommended range for cuff pressure is 20-25cm of water. we will be using three different methods of endotracheal tube cuff inflation in adult patients undergoing general anaesthesia with endotracheal intubation and check to see which is the best in achieving the cuff pressures in the recommended range. after a written and informed consent the methods used are pilot balloon palpation following cuff inflation by a regular 10ml syringe, use of loss of resistance syringe used in epidural sets and a syringe device with pressure sensor. we hypothesise that most appropriate cuff pressures are achieved by syringe device with pressure sensor. study design is a prospective interventional randomised controlled study with a sample size of 150 comprising 50 patients per group.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator 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

  • under American society of physical status (ASA) grade 1-3 who are undergoing elective surgical procedure lasting upto 3 hours.

排除标准

  • surgical procedure duration greater than 3 hours.
  • patients with anticipated difficult airway.
  • patients with preoperative cough or upper airway diseases.
  • patients with known or anticipated risk of aspiration.

结局指标

主要结局

to compare the accuracy of three different techniques using pressure value in the endotracheal tube cuff immediately following inflation in adult patients undergoing general anaesthesia with endotracheal intubation

时间窗: immediately following inflation of tube cuff

次要结局

  • percentage of patients having cuff pressures within the optimal or recommended range 20-25 cm of water.(24 hour)

研究者

发起方
Dr Suman Saini
申办方类型
Government medical college

研究点 (1)

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