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临床试验/NCT01023568
NCT01023568终止不适用

Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
134
试验地点
2
主要终点
Time to Successfully Intubate Patient.

研究概览

简要总结

The purpose of this study is to compare the effectiveness of two novel videolaryngoscope systems, the Glidescope and the Truview PCD against standard direct laryngoscopy (DL) in pediatric patients. The investigators primary hypothesis is that the use of videolaryngoscope devices, Glidescope and Truview provide better laryngeal views in pediatric patients as measured by Cormack and ehane (C&L) (1 to 4, 4 the worst), without increasing the time taken to intubate (TTI), compared with direct laryngoscopy (DL).

The investigators secondary hypotheses are that the use of Glidescope and Truview PCD provoke less hemodynamic response and fewer episodes of de-saturation in pediatric patients.

详细描述

Advances in airway management have led to development on videolaryngoscopy devices including the Glidescope® (Verathon Inc, Bothwell, USA), the AWD® (Pentax Corporation, Tokio, Japan) and most recently the Truview PCD (Truphatek International Ltd, Netanya, Israel). The use of videolaryngoscopy devices in adults have demonstrated some advantages including, minimal trauma on the airway and better view of the glottis.

The Glidescope is designed with a 60º angle and a camera on the inferior aspect just at the inflection point. The view is obtained anteriorly and the camera is located remote from the glottis providing a good visual field. The video image is displayed on a Liquid Crystal Display (LCD), with electronic recording available. Despite a good experience using Glidescope in adults, few studies have been published in pediatric patients. Kim et al. in a randomized study comparing the use of Glidescope with direct laryngoscopy in children, demonstrated better or equal laryngoscopic view with longer time for intubation using the Glidescope.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
— 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I-III
  • elective general surgical procedures
  • from 0-10 years-old

排除标准

  • increase intracranial pressure
  • history of severe gastrointestinal reflux
  • sore throat
  • upper respiratory airway infection
  • known or suspected difficult airway or coagulopathy

结局指标

主要结局

Time to Successfully Intubate Patient.

时间窗: from start of intubation to successfully intubated up to 5 minutes

次要结局

  • Mean Hemodynamic Response: Mean Arterial Blood Pressure(measured at 1 minute interval at induction time and from intubation for 10 minutes)
  • Cormack-Lehane Grade(immediately after intubation)
  • Number of Participants Who Experienced Desaturation(measured at 1 minute interval at induction time and from intubation for 10 minutes.)
  • Mean Hemodynamic Response: Heart Rate(measured at 1 minute interval at induction time and from intubation for 10 minutes.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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