跳至主要内容
临床试验/CTRI/2025/03/082319
CTRI/2025/03/082319尚未招募3 期

Comparing learning curve of McCoy laryngoscope and TAScope for endotracheal intubation by 2nd year anaesthesia residents in simulated difficult airway

Pt BD Sharma PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年3月25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
70
试验地点
1
主要终点
To evaluate the time required for modified Cormack-Lehane grading, Percentage of glottic opening (POGO) score and intubation difficulty score (IDS).

研究概览

简要总结

This present, prospective, comparative study will be conducted in Department of Anaesthesiology and Critical Care, Pt.BD. Sharma PGIMS, Rohtak.Fourteen 2nd year anaesthesia residents will be randomized into two groups, Group T and Group M of seven residents each using opaque sealed envelope. Seventy patients will be equally randomized into both the groups using computer generated random number sequence.  Each resident will perform 5 intubations each.The study will consist of three parts. Part 1 study will include a video demonstration of the tracheal intubation technique using TAScope or McCoy laryngoscope. Part 2 will consist of extensive manikin training (Laerdal Airway Management Trainer). Each resident will do minimum of 5 intubations with the allocated device. The manikin training will be considered complete when the resident will accomplish three successful intubations in a row. In part 3 resident will be allowed to perform intubation on the anaesthetized patient under the close supervision of the attending anaesthesiologist. Each participant will intubate five anaesthetized patients with allocated laryngoscope , and data related to intubation will be recorded by an independent observer.The primary end points will be time required for modified CL grading, POGO score and intubation difficulty score (IDS) for each device. The secondary end points to be checked will be intubation time and successful placement of the tracheal tube. The additional end points will include the incidence of dental trauma, number of optimization maneuvers required for intubation, arterial oxygen saturation during or after attempts, other minor complications (trauma to lip or oral mucosa and presence of blood on blade).   .

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 55.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 18 to 55 years, belonging to American Society of Anaesthesiologists physical status I-II, Mallampati grade 1 or 2, thyromental distance more than 6cm, interincisor distance more than 3.5cm and who are scheduled for elective surgery under general anaesthesia and tracheal intubation will be included in the study.

排除标准

  • Patients with Mallampati grade 3 or 4, thyromental distance less than 6cm, interincisor distance less than 3.5cm, restricted neck movement, receding mandible, facial abnormalities, risk of regurgitation and aspiration (For example intestinal obstruction, hernia, intestinal perforation etc), chest wall deformity, anticipated difficult airway, known advanced cardiovascular diseases, obstructive sleep apnea and refusal to participate in the study.

结局指标

主要结局

To evaluate the time required for modified Cormack-Lehane grading, Percentage of glottic opening (POGO) score and intubation difficulty score (IDS).

时间窗: At the time of laryngoscopy.

次要结局

  • Intubation time & successful placement of the tracheal tube.(Time from insertion of blade in the oral cavity till the appearance of capnography.)

研究者

发起方
Pt BD Sharma PGIMS Rohtak
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Kirti Kshetrapal

Department of anesthesiology and critical care, Pt. B.D. Sharma PGIMS Rohtak

研究点 (1)

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