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临床试验/CTRI/2024/03/064151
CTRI/2024/03/064151尚未招募不适用

A Comparative Study of Endotracheal Tube Cuff Pressure and Postoperative Throat Symptoms using Air Versus Saline for Cuff Inflation

Pratibha Kane1 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2024年4月15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
348
试验地点
1
主要终点
Comparision of increase in intracuff pressure when saline or air is used for cuff inflation.

研究概览

简要总结

A total of 348 patients between the age of 18-65 years will be studied. ASA I ( normal healthy person ) and II ( patients with mild systemic disease ) grades undergoing general anaesthesia for greater than 60 minutes duration will be included. An informed written consent will be taken for willingness to participate in this study. Patients will be randomized into two groups , group ’A’ and group ’S’, using a closed envelope method. In group ’A’, endotracheal tube cuff will be inflated with air and in group ’s’, endotracheal tube will be inflated with 0.9% normal saline. 7.0/7.5 mm tube will be used in female patients and 8.0/8.5 mm tube used in male patients. After following all standard protocols for induction, tracheal intubation is performed. No lubricant is applied on the endotracheal tube. The endotracheal tube cuff will be inflated with minimum volume of air or saline required to acheive a seal so as not to have a leak in the circuit. The cuff pressure will be measured using the cuff pressure gauge by Ambu. The cuff pressure will be noted by the investigator after every 60 minutes of the procedure and at the time of extubation.When the cuff pressure is more than 30 cm H2O, it will be noted and adjusted to 25 cm H2O.The incidence and intensity of postoperative throat symptoms like sore throat , cough, hoarseness of voice and dysphagia in both groups will be evaluated using a questionnaire by nurses in the PACU at 1 hour and at 24 hours by the ward nurses.

研究设计

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

  • All patients undergoing general anaesthesia for more than 1 hour duration.

排除标准

  • Surgery on head and neck If patient is a smoker Use of nitrous oxide as inhalational anesthetic Patient refusal.

结局指标

主要结局

Comparision of increase in intracuff pressure when saline or air is used for cuff inflation.

时间窗: Endo tracheal tube cuff Pressures measured at induction and every hour till extubation. Patient assessed for throat symptoms at 1 hour and at 24 hours after extubation. Patient assessed for throat symptoms at 1hr and 24 hrs after extubation. Correlation of cuff pressures and throat symptoms compared in two groups

次要结局

  • Relation of the rise in intracuff pressure & postoperative throat symptoms monitored at 1 hour & 24 hours post extubation.(Endo tracheal tube cuff Pressures measured at induction & every hour till extubation. Patient assessed for throat symptoms at 1 hour & at 24 hours after extubation. Correlation of cuff pressures & throat symptoms compared in two groups at 1 hour & 24 hours after extubation.)

研究者

发起方
Pratibha Kane
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

PRATIBHA KANE

Jehangir hospital and Research centre

研究点 (1)

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