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临床试验/CTRI/2018/05/014068
CTRI/2018/05/014068已完成1 期

Comparision of Two Video Laryngoscope: Guide Channel and Optical Laryngoscope in patients undergoing tracheal intubation with cervical spine immobilization

Artemis Health Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月8日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
IDS score was less in King Vision ® (1.63±1.25) as compared to Truview ®

研究概览

简要总结

Following parameters were observed:

  1. Parameters of  Intubation Difficulty Scale (IDS)

  2. Time taken for intubation

  3. Haemodynamic parameters

  4. Complications, if any

In patients with cervical spine immobilization, intubation with King Vision® videolaryngoscope required lesser time than using Truview®EVO2 laryngoscope. No significant difference was found in laryngoscopic view and IDS score with both the devices. There is no statistically significant difference in haemodynamic parameters while intubation and post-intubation in both groups. There is no major complication in any of the groups. To conclude both types of laryngoscopes are safe and efficient for intubation in patients with cervical spine immobilization considering high overall success rate and no significant trauma involved.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

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 ASA II Mallampati class I, II and III.

排除标准

  • Anticipated difficult airway (Mallampati class IV, thyromental distance <6 cm, interincisor gap <3.5 cm).
  • Presence of risk factor for gastric aspiration e.g. pregnancy.
  • Uncontrolled hypertension and diabetes mellitus, cardiac disease, hepatic and renal impairment.
  • Loose teeth and artificial dentures.
  • Oral pathology.
  • CNS disorder.

结局指标

主要结局

IDS score was less in King Vision ® (1.63±1.25) as compared to Truview ®

时间窗: During laryngoscopy and intubation

EVO2 (2.03±1.38). But the difference between King Vision and Truview ®

时间窗: During laryngoscopy and intubation

EVO2 groups were not statistically significant.

时间窗: During laryngoscopy and intubation

次要结局

  • Mean duration of intubation was significantly longer in Truview® EVO2 group as compared to King Vision®.(Haemodynamic parameters (HR, MAP, Spo2) were comparable in both groups with no statistical significant difference.)

研究者

发起方
Artemis Health Institute
申办方类型
Private hospital/clinic

研究点 (1)

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