Channelled Blade Versus Non-Channelled Videolaryngoscope
Comparative Study of the Channelled Blade Astra-Vue Videolaryngoscope and the Non-Channelled CMAC D-Blade Videolaryngoscope in Airway Management: A Randomized Controlled Trial
The goal of this clinical trial is to learn if performance of a channelled blade Astra-Vue videolaryngoscope compared to non channelled hyperangulated C-MAC D-blade videolaryngoscope(Karl Storz, Tuttlingen, Germany) in airway management among adults undergoing elective surgery under general anesthesia. The main primary outcomes measured is the overall time taken to intubation, secondary measures includes the first attempt success rate, ease with intubation and associated complication
Participants are of adults who planned for elective or semi emergency surgery under general anesthesia. They will be screened and recruited with informed and written consent. Intubation information will be collected
研究概览
地位
条件
详细说明
This randomized controlled trial aims to compare the performance of a channelled videolaryngoscope (AstraVue videolaryngoscope) with a non-channelled hyperangulated videolaryngoscope (C-MAC™ D-Blade videolaryngoscope, Karl Storz, Tuttlingen, Germany) in adult patients undergoing elective or semi-emergency surgery under general anaesthesia requiring endotracheal intubation.
Participants will be randomly assigned to intubation using either the channelled AstraVue videolaryngoscope or the non-channelled C-MAC D-Blade videolaryngoscope. Standard anaesthesia induction protocols will be followed.
The primary outcome is the total time to successful intubation. Secondary outcomes include time to glottic visualization, time from glottic visualization to intubation, first-attempt success rate, number of attempts, need for external laryngeal manipulation, haemodynamic responses, and intubation-related complications.
Data will be collected prospectively during the peri-intubation period. The study aims to evaluate whether the channelled design improves intubation efficiency and success compared to the non-channelled videolaryngoscope.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
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Kuala Lumpur
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Petaling Jaya、Kuala Lumpur、马来西亚、59100
- Universiti Malaya Medical Centre
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adult patients aged 18 to 70 years old requiring endotracheal intubation for elective or semi-emergency surgery under general anaesthesia
- ASA I, II and stable ASA III patients
- Patient with Mallampati Score Grade 1 to 3
Exclusion Criteria:
- Patients with known airway abnormalities or anticipated difficult intubation,
- Patients with desaturation before intubation,
- Patients with high risk for aspiration requiring rapid sequence induction
- Patient with known cervical pathology.
- Patient refuse to participate
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Channelled blade videolaryngoscope
Endotracheal intubation done with channelled blade videolaryngoscope
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Intubation with channelled blade videolaryngoscope
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有源比较器：Non channelled hyperangulated blade videolaryngoscope
Endotracheal intubation done with non channelled hyperangulated blade videolaryngoscope
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Intubation done by using Non channelled hyperangulated blade videolaryngoscope
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Time to intubation
大体时间：During the intubation procedure (within minutes after induction of general anaesthesia)
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time from insertion of laryngoscope blade through incisor teeth to visualization of Endotracheal tube into trachea, measured in seconds
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During the intubation procedure (within minutes after induction of general anaesthesia)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
First attempt success rate
大体时间：During the intubation procedure(within minutes after induction of general anaesthesia)
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Successful endotracheal intubation on the first attempt, measured as a proportion of total intubations(%)
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During the intubation procedure(within minutes after induction of general anaesthesia)
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|
Time to Glottic Visualization
大体时间：During the intubation procedure(within minutes after induction of general anaesthesia)
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time from insertion of laryngoscope blade to visualization of glottis, measured in seconds
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During the intubation procedure(within minutes after induction of general anaesthesia)
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Ease of intubation
大体时间：During the intubation procedure an immediate post-intubation period (within minutes after induction of general anaesthesia)
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Ease of intubation assessed using a modified Intubation Difficulty Scale (IDS), which includes parameters such as number of attempts, additional operators, alternative techniques, lifting force, external laryngeal pressure, vocal cord position, and intubation difficulty.
The total score ranges from 0 to ≥5, where a score of 0 classified as easy, 1 to 5 classified as slight difficulty, and >5 as moderate to major difficulty, generally higher score means increasing difficulty
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During the intubation procedure an immediate post-intubation period (within minutes after induction of general anaesthesia)
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Change in Mean Arterial Pressure from baseline
大体时间：Baseline taken during induction prior to intubation, second reading repeated at 1 minute after successful intubation
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Change in Mean arterial pressure measured at 1 minute after successful intubation, expressed as percentage change from baseline value
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Baseline taken during induction prior to intubation, second reading repeated at 1 minute after successful intubation
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Change in Heart rate from baseline
大体时间：Baseline measured prior to intubation, second reading repeat at 1 minute post intubation
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Change in heart rate measured at 1 minute after succesful intubation, expressed as percentage change from baseline value
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Baseline measured prior to intubation, second reading repeat at 1 minute post intubation
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合作者和调查者
调查人员
- 首席研究员：Wei Yen Yeoh、Universiti Malaya
出版物和有用的链接
一般刊物
- Shin KW, Lee SP, Kim T, Choi S, Kim YJ, Park HP, Oh H. Channelled versus nonchannelled Macintosh videolaryngoscope blades in patients with a cervical collar: a randomized controlled noninferiority trial. Can J Anaesth. 2024 Sep;71(9):1261-1271. doi: 10.1007/s12630-024-02769-3. Epub 2024 May 22.
- Chandy J, Pillai R, Mathew A, Philip AV, George SP, Sahajanandan R. A randomized clinical trial comparing the King Vision (channeled blade) and the CMAC (D blade) videolaryngoscopes in patients with cervical spine immobilization. J Anaesthesiol Clin Pharmacol. 2021 Oct-Dec;37(4):604-609. doi: 10.4103/joacp.JOACP_75_20. Epub 2022 Jan 6.
- Biro P, Schlaepfer M. Tracheal intubation with channeled vs. non-channeled videolaryngoscope blades. Rom J Anaesth Intensive Care. 2018 Oct;25(2):97-101. doi: 10.21454/rjaic.7518.252.sch.
- Hirabayashi Y, Hoshijima H, Kuratani N. [Channeled videolaryngoscope: A meta-analysis of randomized controlled trials]. Masui. 2013 Jul;62(7):886-93. Japanese.
- Decamps P, Grillot N, Le Thuaut A, Brule N, Lejus-Bourdeau C, Reignier J, Lascarrou JB. Comparison of four channelled videolaryngoscopes to Macintosh laryngoscope for simulated intubation of critically ill patients: the randomized MACMAN2 trial. Ann Intensive Care. 2021 Aug 16;11(1):126. doi: 10.1186/s13613-021-00916-3.
- Mendonca C, Ungureanu N, Nowicka A, Kumar P. A randomised clinical trial comparing the 'sniffing' and neutral position using channelled (KingVision(R) ) and non-channelled (C-MAC(R) ) videolaryngoscopes. Anaesthesia. 2018 Jul;73(7):847-855. doi: 10.1111/anae.14289. Epub 2018 Apr 16.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- RSCH ID-25-06670-TVG
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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