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临床试验/CTRI/2024/10/075505
CTRI/2024/10/075505尚未招募4 期

Comparative efficacy of I-Gel, Laryngeal Mask Airway-Supreme and Laryngeal Mask Airway-Protector in Short Surgical Procedures under General Anaesthesia with Spontaneous Ventilation - A Randomised Clinical Trial

Dr Damandeep Kaur1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
To compare the efficacy of I-Gel, LMA Supreme, and LMA Protector in maintaining a patent airway during short surgical procedures.

研究概览

简要总结

While previous studies have compared different supraglottic airway devices or focused on other aspects, a dedicated investigation directly comparing these three commonly used devices could offer more precise guidance to clinicians in selecting the most suitable device for positive pressure ventilation in anesthetized patients. Therefore, our study aims to fill this gap by providing a comprehensive comparison among I-Gel, LMA-Supreme and LMA Protector, focusing on insertion ease, insertion time, placement attempts, airway leak pressure, and complications, ultimately aiming to optimize patient care and outcomes in anesthesia settings.

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 60.00 Year(s)(—)
性别
All

入选标准

  • ASA Grading I ,II Patients undergoing elective short surgeries less than 1.5hrs under general anaesthesia.

排除标准

  • Non Consenting Patient BMI more than 30Kg/m2 Difficult airway MPC Class ≥3 Uncontrolled Co-morbid illness H/O GERD, Hiatus Hernia Musculo-skeletal Abnormalities Like Cervical Spine Deformities Obstructive Sleep Apnea.

结局指标

主要结局

To compare the efficacy of I-Gel, LMA Supreme, and LMA Protector in maintaining a patent airway during short surgical procedures.

时间窗: Baseline(To) | 1 min after insertion T1 | 3 min T2 | 5 min T3 | 15 min T4 | 30 min T5 | 45 min T6 | 60 min T7 | 75 min T8 | 90 min T9 | 105min T10

次要结局

  • To evaluate the insertion characteristics, including ease and success rates, of the three supraglottic airway devices.

研究者

发起方
Dr Damandeep Kaur
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Damandeep Kaur

Adesh Institute of Medical Sciences and Research

研究点 (1)

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