跳至主要内容
临床试验/CTRI/2023/09/057251
CTRI/2023/09/057251尚未招募不适用

A randomised control study to compare glottic view between Macintosh laryngoscope and King Vision Video laryngoscope in patients requiring endotracheal intubation in intensive care unit

M S Ramaiah Medical College1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年11月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
76
试验地点
1
主要终点
To compare the glottic view

研究概览

简要总结

Endotracheal intubation is the first step in any resuscitation to maintain patency of airway and if it is not secured well all the other lifesaving manoeuvres can fail. Direct laryngoscopy has been the standard technique for tracheal intubation for almost a century which requires aligning the pharyngeal, laryngeal and oral axes to achieve a line of sight.

Airway management problems constitute 17% of anaesthesia closed claims, with difficult intubation being the most common at a rate of 5%. According to the American Society of Anaesthesiologists, the incidence of difficult intubation in the operating room is 1.2–3.8%; however, in emergency conditions, this rate is higher and reaches even 5.3%. Approximately 6% to 10% of patients undergoing surgical intervention are considered difficult laryngoscopy patients. The lack of first-pass success (FPS) in intubation has been associated with increased adverse events. Problems like delayed intubation, misplaced tracheal tube, or airway trauma are frequently encountered and can cause death or hypoxic brain damage.

However over the last decades, technological advances have enabled the development of different devices for airway management. One such device is King Vision Video Laryngoscope (KVVL) which is used for management of normal and difficult airway. It is an indirect laryngoscope that provides view of glottis without alignment of oral, pharyngeal and tracheal axes. Limited studies are available for comparing the efficacy of Macintosh Laryngoscope and King Vision Video Laryngoscope for intubation in intensive care unit.

Hence we aim at comparing the efficacy of Macintosh laryngoscope and King Vision Video laryngoscope for glottic view, first attempt success rate of intubation and time taken for intubation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • •Hemodynamically stable patients.

排除标准

  • •Patient refusal Pregnant woman Limited mouth opening Cervical spondylosis Malformation of face Airway tumors Midline neck swelling BMI >30kg/m2.

结局指标

主要结局

To compare the glottic view

时间窗: To assess glottic view in terms of Cormack Lehane grading | Grade 1- full view of glottis | Grade 2- Partial view of glottis or aretynoids | Grade 3- only epiglottis visible | Grade 4- Neither glottis nor epiglottis visible

次要结局

  • To compare first attempt success rate of intubation & time taken for intubation(To assess first attempt success rate of intubation in terms of yes or no & time taken for intubation in seconds)

研究者

申办方类型
Private medical college

研究点 (1)

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