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临床试验/NCT02694705
NCT02694705已完成不适用

Assessment of Preoxygenation Strategies in the Prehospital Environment

Queen Mary University of London2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年2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
30
试验地点
2
主要终点
Fractional Expired Oxygen Concentration

研究概览

简要总结

Comparison of the preoxygenation efficacy of tidal volume breathing using three different preoxygenation techniques which are available to providers in the prehospital environment.

详细描述

Prospective randomised interventional study.

Healthy volunteers will be positioned supine and undergo preoxygenation by tidal volume breathing for 3 minutes using each technique in turn. The sequence of techniques for each volunteer will be randomised in advance. Investigators will be instructed to ensure a good mask seal throughout the testing period. At the end of a 3 minute preoxygenation period, after a brief breath hold, the volunteer will exhale into reservoir tubing, allowing the fractional expired oxygen concentration (FeO2) to be determined (primary outcome) using a calibrated gas analyser.

The techniques being assessed have been chosen from methods of preoxygenation commonly available to clinicians in the prehospital environment:

  1. Continuous Positive Airway Pressure mode with fractional inspired oxygen concentration (FiO2) 100% using a portable ventilator.
  2. Bag-valve-mask device (BVM) with 15 l/min oxygen flow.
  3. Non-rebreather mask (NRM) device with 15 l/min oxygen flow.

Volunteers will also be asked to indicate the subjective ease of breathing for each technique (secondary outcome) using a visual analogue scale (VAS).

研究设计

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

入排标准

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

入选标准

  • Adult volunteers

排除标准

  • Pregnancy
  • Respiratory disease
  • Facial abnormality
  • Edentulous

结局指标

主要结局

Fractional Expired Oxygen Concentration

时间窗: 3 minutes

Measure of denitrogenation efficacy

次要结局

  • Ease of breathing assessment using a visual analogue scale(3 minutes)

研究者

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

Christopher Groombridge

Dr

Queen Mary University of London

研究点 (2)

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