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临床试验/CTRI/2023/01/048986
CTRI/2023/01/048986已完成不适用

Comparison of Tracheal Intubation using Video-laryngoscopy versus Video-laryngoscope assisted Flexible Tracheoscopy in patients with simulated Manual In-Line Stabilization - A Randomized Control Trial.

JIPMER1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2023年1月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
JIPMER
入组人数
158
试验地点
1
主要终点
Time taken to intubate with Video-laryngoscopy Versus Video-laryngoscopy assisted Flexible Tracheoscope in patients with Manual In-Line Stabilization

研究概览

简要总结

After obtaining informed consent, patients presenting for elective or emergency surgery under general anaesthesia requiring tracheal intubation will be included in the study. Pre-anaesthetic and complete airway assessment will be done before surgery. After  administering pre-medication and attaching standard ASA monitors, patients will be randomized into two groups - VLS and VLF. Anaesthesia will be induced using 2 mcg/Kg Fentanyl, 2 mg/Kg propofol and 0.1 mg/Kg vecuronium. Face mask ventilation will be done for three minutes after which the pillow placed under the patient’s head will be removed. The patient’s head will be stabilized using MILS manouvre applied by an assistant standing on  the left side of  patient’s head. In group VLS,  intubation will be performed using C-Mac Video-laryngoscope. In group VLF, C- MAC video-laryngoscope will be inserted into the patient’s oral cavity by the primary anaesthesiologist which will the be handed over to an assisting anaesthesiologist after obtaining glottic view. The primary anaesthesiologist will then intubate using the flexible Tracheoscope ( aScope, Ambu Inc.,) which has been railroded with the Endotracheal tube. Time Taken to Intubate ( TTI) will be the time taken from the insertion of video-laryngoscope into the oral cavity until the appearance of 3 square capnogram waveforms. An attempt at intubation will be defined as the attempt to insert the video-laryngoscope blade into the oral cavity. Failed intubation will be defined as failure to intubate within 2 attempts

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • Patients scheduled for elective or emergency surgery requiring general anaesthesia with tracheal intubation 2) with ASA physical status classification 1 to 33 3) with modified Mallampati class 1 and 2.

排除标准

  • presence of predictors of difficult airway such as reduced mouth opening, restricted neck movements, BMI greater than 32 Kg/m2 and cervical spine pathology 2) patients requiring rapid sequence induction and intubation.

结局指标

主要结局

Time taken to intubate with Video-laryngoscopy Versus Video-laryngoscopy assisted Flexible Tracheoscope in patients with Manual In-Line Stabilization

时间窗: after induction of anaesthesia

次要结局

  • 1)Rate of first attempt successful intubation between the two groups(2) Incidence of complications such as desaturation, airway injury and bleeding and post-operative throat pain)

研究者

发起方
JIPMER
申办方类型
Research institution

研究点 (1)

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