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临床试验/NCT05499273
NCT05499273已完成不适用

Pediatric Neck Rescue: Randomized Comparison of Two Emergency Approaches to the Trachea in an Advanced Simulated Rabbit Model

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Performance Time

研究概览

简要总结

Two recent studies explored the emergency tracheotomy technique and the scalpel-bougie-tracheostomy technique as a neck rescue access for newborns and infants on a rabbit cadaver. Both studies lacked a key feature of real surgical access - bleeding during a true emergency. The study's objective was to comparatively assess the two techniques in a simulated environment with simulated bleeding and decreasing vital signs from the monitor like in real emergencies.

详细描述

With ethical committee's approval the investigarors recruited for this cross-over trial pediatric anesthesiologists and intensivists. Emergency tracheotomy consists of four steps: vertical skin incision, strap muscles separation (2 Backhaus clamps), anterior luxation of the trachea with a 3rd clamp, and vertical puncture with tip-scissors of no more than 2 tracheal rings to insert the tube. The scalpel-bougie-tracheostomy involves separation of neck tissues to expose the trachea and tracheal incision both with a scalpel to insert the bougie to facilitate tracheal intubation. Participants were randomized to start either with emergency tracheotomy or scalpel-bougie-tracheostomy. They watched an instructional video and had four practicing attempts, followed by a fifth attempt which was assessed. Afterward, they crossed over to the other technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • board certified pediatric anesthesiologists or pediatric intensive care doctor
  • informed consent signed

排除标准

  • 未提供

结局指标

主要结局

Performance Time

时间窗: 2 min

performance time between the rapid sequence tracheotomy technique and the scalpel-bougie tracheostomy technique.

次要结局

  • rate of thyroid injuries(2 min)
  • rate of cricoid injuries(2 min)
  • Succes rate(2 min)
  • number of tracheal ring damaged(2 min)

研究者

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

Thomas Riva

PD Dr. med.

Insel Gruppe AG, University Hospital Bern

研究点 (2)

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