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临床试验/NCT03992092
NCT03992092Unknown不适用

Comparison of Video Stylet to Flexible Bronchoscopy for Intubation of Patients With Potential Cervical Spine Injury

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Time to Intubation

研究概览

简要总结

Comparison of cervical spine movement during intubation with the C-MAC Video Stylet to Flexible Bronchoscopy

详细描述

Elective surgical patients who require intubation will be randomised to one of 2 groups:

  1. C-MAC Video Stylet
  2. Flexible Bronchoscopy During intubation, fluoroscopy will be recorded for later analysis to determine the amount of cervical spine movement during the intubation process.

The intubation will also be timed to determine the duration of the intubation process.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Participants will be blinded, as will Anesthesiologist providing care, but the investigator who performs the intubation will be aware of the intubation technique he used. Similarly, the Radiologist measuring the C-spine movement will be able to see the device on the fluoroscopic images.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Elective Surgery requiring oral intubation
  • •undergoing elective non-cardiac surgery
  • •American Society of Anesthesiologists physical status 1-3
  • •age 18-80 years

排除标准

  • •gastro-esophageal reflux disease
  • •body mass index > 35 kg/m2
  • •possibility of pregnancy
  • •previous neck surgery
  • •unstable C-spine
  • •known or predicted difficult airway.

研究组 & 干预措施

C-Mac VS

Experimental

Intubation using the C-MAC Video Stylet

干预措施: C-MAC VS (Device)

FB

Active Comparator

Intubation using the Flexible Bronchoscope

干预措施: Flexible Bronchoscopy (Device)

结局指标

主要结局

Time to Intubation

时间窗: Concurrent, during the intubation

Duration of Intubation

次要结局

  • Vocal Changes(24-48 hours post-op.)
  • Ease of Intubation(Concurrent, during the intubation)
  • C-Spine Movement(Concurrent, during the intubation)
  • Sore Throat(24-48 hours post-op.)

研究者

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

Timothy Turkstra

Associate Professor and Staff Anesthesiologist

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (1)

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