跳至主要内容
临床试验/NCT00935636
NCT00935636已完成不适用

An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Time to intubation

研究概览

简要总结

The purpose of this study is to collect relevant airway data using the GlideScope Cobalt Video Baton 1 and 2 for intubation in a large cohort of neonates and infants weighing 10 kg or less.

详细描述

Neonates and infants requiring endotracheal intubation and in which the attending anesthesiologist decided to use the CGS-CVB will be included in this observational study. Data will be collected by one of the investigators or the research assistant/coordinator and recorded on a data sheet The data from these forms will be then entered by the investigator or research assistant/coordinator into a database maintained only for this study.

The decision of using the GS-CVB is at the discretion of the attending anesthesiologist. Consequently if consent would be required the anesthesiologist might feel compelled or biased to use the device against his will. This will also require that all possible patients's should be consented which will put a serious strain on the study personal.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates, infants and children scheduled for surgical procedures under general anesthesia and requiring endotracheal intubation
  • Patients age 0 - 2 years
  • Weight up to 10 kg
  • American Society of Anesthesiologists physical status I-III

排除标准

  • Patients at risk of pulmonary aspiration,
  • Increased intracranial pressure
  • Those with congenital cardiac diseases or
  • Those with hemodynamic instability

结局指标

主要结局

Time to intubation

时间窗: From the time the ETT enters the mouth until end-tidal carbon dioxide is detected on the monitor screen

次要结局

  • The time to laryngoscopic views, number of attempts, and the success rate(from the time the device enters the mouth until the best view is acknowledged.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Szmuk

Professor

University of Texas Southwestern Medical Center

研究点 (1)

Loading locations...

相似试验