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临床试验/CTRI/2025/04/084243
CTRI/2025/04/084243尚未招募1/2 期

Comparative study of assessing the glottic view with proseal and I GEL supraglottic airway devices- randomized control study

Dr Shri Sravan1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年4月20日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
Assessing the glottic view obtained between Proseal and I GEL supraglottic airway devices

研究概览

简要总结

BACKGROUND- Supraglottic airway devices are an essential part of managing difficult airway situation, wherein they are used to maintain ventilation. A fiberoptic bronchoscope can be inserted via a supraglottic airway and the glottic aperture visualized for adequate opening so that endotracheal intubation can be facilitated with the help of a tracheal tube exchanger. Brimacombe grading system will help to grade the glottic opening. This study aimed to compare the best glottic view obtained between Proseal and I GEL supraglottic airway device, assessed with fiberoptic bronchoscope using brimacombe grading.-

METHODOLOGY- This prospective randomized controlled study, includes patients undergoing elective surgical procedures under general anesthesia using supraglottic airway device. Two groups: GROUP P- patients undergoing elective surgical procedures using Proseal supraglottic airway and GROUP I- patients undergoing elective surgical procedure under IGEL supraglottic airway. The primary objective is to assess the best glottic opening obtained between the two devices. The secondary objectives are to assess the adequacy of ventilation after supraglottic airway device placement and the number of attempts required for insertion of device

CONCLUSION- This study provides valuable insights into the glottic view obtained with Proseal and I GEL supraglottic airway using fiberoptic bronchoscope and brimacombe grading. It helps in repurposing the more commonly used supraglottic airway device as alternatives to the intubating LMA. By assessing the glottic view, adequacy of ventilation, and ease of insertion this study enhances the understanding of each device’s effectiveness in managing a difficult airway situation. The results may help guide clinical decision making, improving airway management strategies and patient outcomes.

研究设计

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

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • American society of anaesthesiology physical status classification, class 1,2 and 3 patients.
  • Elective surgical procedures planned under general anaesthesia using proseal and I GEL supraglottic airway devices.

排除标准

  • Any contraindication to the use of supraglottic airway devices (uncontrolled gastro-esophageal reflux, oropharyngeal pathology or gross deformities, edentulous, loose tooth).
  • Difficult airway.
  • Patient refusal.

结局指标

主要结局

Assessing the glottic view obtained between Proseal and I GEL supraglottic airway devices

时间窗: Baseline glottic opening will be assessed immediately after airway placement among patients undergoing elective surgical procedures under general anaesthesia, using supraglottic airway devices

次要结局

  • Assessing the adequacy of ventilation after supraglottic airway device placement.(adequacy of ventilation will be assessed once immediately after airway placement during planned elective surgical procedures under general anaesthesia, using supraglottic airway devices.)

研究者

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

Shri Sravan

PSG institute of medical sciences and research

研究点 (1)

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