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临床试验/CTRI/2019/09/021279
CTRI/2019/09/021279已完成不适用

Comparision of endotracheal intubation between Smarttrach, C-MAC and Macintosh laryngoscopes;A randomized prospective clinical trial

Sanjay Gandhi Post Graduate Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2019年3月10日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
375
试验地点
1
主要终点
Primary:Compare the success rates and time for intubation (i.e the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram)

研究概览

简要总结

Macintosh laryngoscopes are commonly used for endo tracheal inubation. Video laryngoscopes are commonly used nowadays like CMAC and Smarttrach. We aim to compare the intubation characteristics of these three laryngoscopes in terms of their overall success rates, number of attempts, time taken, haemodnamic changes, need for external laryngeal manipulation and complications

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA I and II patients undergoing elective surgery.

排除标准

  • Patient refusal Anticipated Difficult Airway ( Mallampatti Class III and IV, thyromental distance <6 cm; and inter-incisor distance <3.5 cm) Obesity( BMI >35) Increased intracranial pressure or cervical spine diseases cardiovascular disease endocrine disease presence of risk factors for gastric aspiration e.g. pregnancy, diabetes, etc.

结局指标

主要结局

Primary:Compare the success rates and time for intubation (i.e the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram)

时间窗: ( the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram) | Secondary:1) CL grading, need of optimization maneuvers, no.of attempts for successful placement, haemodynamic responses, Intubation Difficulty Score (IDS) scale, subjective ease of intubation | 2) Complications like injury to the lips, teeth or tongue and any blood stain on the | device

Secondary:1) CL grading, need of optimization maneuvers, no.of attempts for successful placement, haemodynamic responses, Intubation Difficulty Score (IDS) scale, subjective ease of intubation

时间窗: ( the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram) | Secondary:1) CL grading, need of optimization maneuvers, no.of attempts for successful placement, haemodynamic responses, Intubation Difficulty Score (IDS) scale, subjective ease of intubation | 2) Complications like injury to the lips, teeth or tongue and any blood stain on the | device

2) Complications like injury to the lips, teeth or tongue and any blood stain on the

时间窗: ( the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram) | Secondary:1) CL grading, need of optimization maneuvers, no.of attempts for successful placement, haemodynamic responses, Intubation Difficulty Score (IDS) scale, subjective ease of intubation | 2) Complications like injury to the lips, teeth or tongue and any blood stain on the | device

device

时间窗: ( the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram) | Secondary:1) CL grading, need of optimization maneuvers, no.of attempts for successful placement, haemodynamic responses, Intubation Difficulty Score (IDS) scale, subjective ease of intubation | 2) Complications like injury to the lips, teeth or tongue and any blood stain on the | device

次要结局

  • 1) CL grading, need of optimization maneuvers, no.of attempts for successful ET placement, haemodynamic responses to laryngoscopy, Intubation Difficulty Score (IDS) scale, subjective ease of intubation (VAS)(2) Complications like injury to the lips, teeth or tongue and any blood stain on the)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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