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临床试验/NCT05001607
NCT05001607Unknown不适用

A Novel Method of Lung Isolation Compared With Standard Methods in a Model of Massive Pulmonary Hemorrhage.

University of British Columbia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月16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
20
试验地点
1
主要终点
Total time to successful lung isolation.

研究概览

简要总结

Dr. Purdy has developed a novel bronchial blocker device that has multiple applications. In this project, a simulation model of massive pulmonary hemorrhage in an adolescent intubating manikin will be used to compare the novel method against 3 published methods of lung isolation.

详细描述

Purpose: To compare a novel airway device in a realistic adolescent airway model of massive pulmonary hemorrhage to three standard methods of lung isolation.

Hypothesis: The novel method will be as fast or faster than traditional methods.

Justification: Lung isolation in massive pulmonary hemorrhage is associated with mortality rates as high as 40%. Current methods of lung isolation are challenging and have a number of limitations. The development of this novel device was a response to the limitations of current solutions and could significantly increase the speed and ease of placing a bronchial blocker under these circumstances.

Objectives: (1) To determine the length of time required for successful lung isolation in each of the four methods trialed. (2) To determine the length of time required for intubation in each of the four methods trialed. (3) To describe challenges in each method within the scenario of massive pulmonary hemorrhage. (4) To assess the utility of the model of massive pulmonary hemorrhage in future simulations.

Research Design: We propose a within-subject randomized procedure evaluation study comparing the placement of a novel bronchial blocker with three standard methods of lung isolation in a massive pulmonary hemorrhage simulation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Practicing anesthesiologists
  • •Anesthesia fellows

排除标准

  • •Those who don't want to participate

研究组 & 干预措施

Study trial

Other

All participants will perform pulmonary blockade on an intubating manikin using 4 different methods: Endobronchial intubation with an endotracheal tube; Bronchial blocker attached to the outside of an endotracheal tube; Double lumen endotracheal tube; and Intraluminal placement of bronchial blocker.

干预措施: Bronchial Blocker (Device)

结局指标

主要结局

Total time to successful lung isolation.

时间窗: Within 10 minutes from start of direct laryngoscopy

Total time from start of direct laryngoscopy to establishment of lung isolation confirmed by one lung ventilation.

次要结局

  • Time to successful method placement(Within 10 minutes from successful intubation)
  • Model utility(At the end of the trial, within an hour of starting the first practice intubation.)
  • Time to successful intubation(Within 10 minutes from start of direct laryngoscopy)

研究者

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

F. Robert Purdy

Principle Investigator

University of British Columbia

研究点 (1)

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