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临床试验/CTRI/2024/04/065357
CTRI/2024/04/065357尚未招募3 期

A Comparison of blind intubation with fiberoptic guided intubation through Blockbuster(TM) Laryngeal Mask Airway using PolyVinylChloride Tube in Adults

Department of Anaesthesiology Intensive Care1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年4月16日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
78
试验地点
1
主要终点
To compare the first pass success rate of blind intubation with that of fiberoptic guided intubation through BlockbusterTM laryngeal mask airway device, using polyvinyl chloride endotracheal tube.

研究概览

简要总结

This study is randomized, double blind parallel group trial to compare Blind intubation with Fiberoptic guided intubation through Blockbuster laryngeal mask airway using polyvinylchloride tube in adults patient that will be conducted at Department of Anaesthesiology & Intensive Care, Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi for 18 months after seeking clearance from Institutional Ethics Committee. This study includes patients belonging to ASA Grade I & II aged between 18yrs to 60yrs of both genders undergoing elective surgery of less than 3 hours anticipated duration of surgery requiring General Anaesthesia with orotracheal intubation with supine postion intraoperatively. The primary outcome measures the first pass success rate of blind intubation with that of fiberoptic guided intubation through blockbuster LMA. The secondary outcome will be measuring endotracheal tube insertion characteristics i.e. ease of insertion, number of attempts for successful intubation, time taken for intubation, manuevers required for tube insertion & will also measure hemodynamic changes i.e. Blood Pressure change(Systolic BP/Diastolic BP), Heart rate changes, oxygen saturation changes. We hypothesise from this study that the blind intubation is similar to fiberoptic guided intubation through blockbuster LMA using PolyVinylChloride Tube in adults.

研究设计

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

  • All patients belonging to American Society of Anaesthesiologists (ASA) grade I & II; aged between 18yrs to 60yrs of both the genders, undergoing elective surgery of less than 3 hours anticipated duration of surgery requiring General Anaesthesia with orotracheal intubation with supine position intra-operatively.

排除标准

  • •Predicted difficult airway •Increased aspiration risk- Recent trauma, full stomach, pregnancy, intestinal obstruction, gastroesophageal reflux disease.

结局指标

主要结局

To compare the first pass success rate of blind intubation with that of fiberoptic guided intubation through BlockbusterTM laryngeal mask airway device, using polyvinyl chloride endotracheal tube.

时间窗: Preop, at time of insertion of blockbuster LMA, at time of endotracheal intubation thorugh blockbuster LMA, 1 min after insertion, 3 min after insertion, 5 min after insertion, 10 min after insertion, at time of extubation & in post anaesthesia care unit

次要结局

  • I. Endotracheal tube Insertion characteristics

研究者

发起方
Department of Anaesthesiology Intensive Care
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sujata Chaudhary

Guru Gobind Singh Indraprastha University

研究点 (1)

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