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临床试验/CTRI/2024/07/070615
CTRI/2024/07/070615招募中不适用

A pragmatic, observational study of machine-delivered pressure-support and reservoir bag-based manual weaning and extubation following general anaesthesia

All India Institute of Medical Sciences, Guwahati1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
154
试验地点
1
主要终点
Coughing and bucking severity

研究概览

简要总结

While research for reducing emergence coughing and bucking during anesthesia reversal and extubation has been well studied, most of the studies are done for preventing the emergence coughing and bucking by using different medications and endotracheal tube management. PS-based weaning is widely practiced in critical care and is an age-old technique now commonly practiced in the operation theatre. However, our basic search in PubMed on 30th April 2024 did not find a direct comparison between the two methods.

Aim: This study compares the emergence characteristics of general anaesthesia after reservoir bag-based weaning with pressure support-based weaning following surgery with endotracheal intubation.

Primary objective: To compare the incidence and severity of coughing and bucking during anesthesia emergence among the two groups

Hypothesis: Pressure support-based weaning might have smoother emergence characteristics than Reservoir bag-based weaning and extubation in patients undergoing general anesthesia reversal.

This is an observational study, no intervention will be done. Data will be collected.

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

  • ASA-PS I-III BMI 18.5 – 29.99 kg/m2 Both male and female Non-cardiac surgeries Elective surgeries.

排除标准

  • Obstetric patients Patients on vasoactive drug infusion for hypertensive crisis or shock Double lumen tube use Patients not extubated on table Anaesthesia duration less than 60 min and more than 300 min A special group of patients Any deviation or alternative technique of extubation if employed Patients requiring more than 3 units of PRBC transfusion Patients having eGFR less than 60 mL per min Known case of COPD GOLD class 3 and above Smoking 20 cigarettes per day in the past 48 hours.

结局指标

主要结局

Coughing and bucking severity

时间窗: Baseline, Extubation

次要结局

  • haemodynamic variations like blood pressure, mean arterial pressure, heart rate, EtCO2, minute ventilation(At 1, 3, 5, 7 and 10 min of reversal administration.)

研究者

发起方
All India Institute of Medical Sciences, Guwahati
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ankita Medhi

All India Institute of Medical Sciences, Guwahati

研究点 (1)

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