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临床试验/NCT03093662
NCT03093662已完成不适用

Analysis of Preoxygenation Combining Nasal Cannula With Noninvasive Positive Pressure Ventilation: A Randomized Crossover Trial

Brooke Army Medical Center1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年3月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
End-tidal Oxygen

研究概览

简要总结

This is a prospective randomized cross over study of healthy volunteers comparing end-tidal oxygen concentration among subjects undergoing continuous positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal cannulas.

详细描述

Noninvasive positive pressure ventilation with the addition of a nasal cannula is a useful technique to pre-oxygenate and provide apneic oxygenation in hypoxic patients undergoing emergency airway management. This study aims to evaluate preoxygenation by quantifying end-tidal oxygen (etO2) concentration resulting from nasal cannula placement underneath a noninvasive positive pressure ventilation (NIPPV) mask. This is a prospective randomized cross over study of healthy volunteers undergoing continuous positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal cannulas. End-tidal oxygen concentration will be measured by an oxygen sensor following three minutes of NIPPV with and without the addition of a nasal cannula, with each subject serving as his or her own control.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Any healthy volunteer aged 18-65 years.

排除标准

  • •Previous inability to tolerate noninvasive positive pressure ventilation with addition of a nasal cannula.
  • •Known underlying cardiac or pulmonary disease.
  • •Active respiratory infections.

研究组 & 干预措施

Ventilation with nasal cannula

Experimental

Non-invasive positive pressure ventilation with nasal cannula.

干预措施: Ventilation with nasal cannula (Device)

Ventilation with nasal cannula

Experimental

Non-invasive positive pressure ventilation with nasal cannula.

干预措施: Ventilation without nasal cannula (Device)

Ventilation without nasal cannula

Active Comparator

Non-invasive positive pressure ventilation without nasal cannula.

干预措施: Ventilation with nasal cannula (Device)

Ventilation without nasal cannula

Active Comparator

Non-invasive positive pressure ventilation without nasal cannula.

干预措施: Ventilation without nasal cannula (Device)

结局指标

主要结局

End-tidal Oxygen

时间窗: 3 minutes after study start

Measured by exhalation into sensor (Maxtec Max-250E)

次要结局

未报告次要终点

研究者

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

Michael D. April

Assistant Program Director for Research, Emergency Medicine

Brooke Army Medical Center

研究点 (1)

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