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临床试验/CTRI/2025/08/092377
CTRI/2025/08/092377尚未招募不适用

Comparison of two different head positions for successful insertion of supraglottic airway device in adult patients undergoing elective surgery under general anaesthesia

Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年8月20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
90
试验地点
1
主要终点
First attempt success rate (using BRIMACOMBE SCORING)

研究概览

简要总结

This prospective, randomized study aims to compare the success of supraglottic airway device (SAD) insertion in two different head positions [without elevation (Group X) and with 5 cm head elevation (Group Y)] in adult patients undergoing elective surgery under general anaesthesia. Following Institutional Ethics Committee approval and written informed consent, 90 patients will be enrolled. Preoperative assessment will include airway evaluation using Mallampati score and mouth opening. Standard ASA monitoring will be applied, and patients will be premedicated with midazolam and fentanyl, followed by induction with propofol and muscle relaxation using vecuronium.

Patients will be randomized into two groups based on head positioning. A properly sized SAD will be inserted using the introducer technique with the neck in extension, and cuff inflation will be standardized at 60 cm H2O. The success of insertion will be confirmed using fibreoptic bronchoscopy and Brimacombe scoring. Time to successful insertion will be recorded until the first square EtCO2 waveform. Failure on first attempt will result in exclusion from the study, and airway management will proceed with endotracheal intubatio

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Elective surgical procedure under General Anaesthesia.

排除标准

  • Trauma,Tumor or deformity of Upper Airway Patient with Thyroid and Neck Swelling Fracture and deformity of Cervical Spine Past History of Difficult Intubation.

结局指标

主要结局

First attempt success rate (using BRIMACOMBE SCORING)

时间窗: From Baseline till 5 minutes after insertion of Supraglottic Airway Device

次要结局

  • Total time taken for SAD insertion(Complications(if any))

研究者

发起方
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Harsh Jain

ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi

研究点 (1)

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