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临床试验/CTRI/2021/08/035986
CTRI/2021/08/035986已完成不适用

Comparison of first intubation success rate of C-MAC video laryngoscope and direct laryngoscope guided intubation by anesthesiology residents following rapid sequence induction : Randomized controlled trial

Jawaharlal institute of postgraduate medical education and research1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2021年1月9日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
172
试验地点
1
主要终点
To compare the first intubation success rates of video laryngoscope and direct laryngoscope

研究概览

简要总结

CMAC video laryngoscope has the design and technique of use similar to Macintosh direct laryngoscope and training required is also similar. By increasing the first intubation success rate it may reduce the complications associated with repeated and failed intubation. Currently the evidences to show the superiority of video laryngoscope over direct laryngoscope at operation rooms by anesthesiology trainee are limited CMAC video laryngoscope has the design and technique of use similar to Macintosh direct laryngoscope and training required is also similar. By increasing the first intubation success rate it may reduce the complications associated with repeated and failed intubation. Currently the evidences to show the superiority of video laryngoscope over direct laryngoscope at operation rooms by anesthesiology trainee are limited

In this project after taking informed consent and getting examined by the anaesthesiologist , pateints will be randomly divided into two groups , group one will be intubated with Macintosh direct laryngoscope and group two with C-MAC video based laryngoscope.

two groups will be divided by serially numbered sealed, opaque envelopes.  An anaesthesia trainee doctor will perform laryngoscopy (a procedure to see your voice box by inserting a laryngoscope) and subsequently insert an artificial tube through the voice box and into the airway tube. Once the position of the artificial tube is checked, artificial ventilation will be commenced by connecting the tube to the ventilator.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Participant 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

  • Patients 18-60 years of age requiring Rapid Sequence Induction for General Anaesthesia
  • American society of anaesthesiologists physical status classification of 1-3.

排除标准

  • Anticipated difficult airway
  • Cervical spine injury
  • Patient on preoperative oxygen therapy
  • Pregnant woman.

结局指标

主要结局

To compare the first intubation success rates of video laryngoscope and direct laryngoscope

时间窗: At the time of intubation

次要结局

  • Duration of first attempt of intubation between the two study groups(At the time of intubation)
  • Any need for adjustments of cricoid pressure between the two groups(During intubation)
  • Any need for external laryngeal manipulation to improve the laryngeal view between the two groups.(During intubation)
  • Any mucosal or dental injury(During intubation)
  • Any need to use intubation aids other than stylet between the two groups(During intubation)
  • Incidence of hypoxia (less than 92%) between the two groups.(During intubation)
  • Laryngoscopic view between the two groups.(During intubation)
  • Incidence of regurgitation or aspiration(During intubation)
  • Heart rate and blood pressure changes during and after intubation(Time from the start of intubation, every one minute till 10 minutes after intubation)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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