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临床试验/NCT02743936
NCT02743936已完成4 期

Analysis of Face Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation: A Randomized Crossover Trial

Brooke Army Medical Center2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
64
试验地点
2
主要终点
Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine

研究概览

简要总结

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. Mask leak will be measured by the ventilator after 60 seconds of spontaneous resting ventilation, with each subject serving as his or her own control.

详细描述

This is a randomized cross over study. A convenience sample of staff and resident physicians and physician assistants from the San Antonio Military Medical Center (SAMMC) Department of Emergency Medicine will be used to assess NIPPV mask seal during CPAP administration with and without nasal cannula. Volunteers will be solicited via Grand Rounds and staff meetings at San Antonio Military Medical Center. Subjects will undergo permuted block randomization by random number generator to the order of intervention, mask alone or mask with nasal cannula at 15L/min of oxygen. An emergency medicine trained physician will place equipment and operate the ventilator. After placement of the NIPPV mask and prior to each study intervention period, appropriate adjustments to enhance mask seal will be made as would happen in a therapeutic setting and the volunteer will be allowed up to two minutes to acclimate to continuous noninvasive positive pressure ventilation. Mask leak will be measured by the ventilator unit and will be recorded after 60 seconds of spontaneous restful ventilation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

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

  • 18 years of age
  • Volunteer for study

排除标准

  • Known cardiac disease
  • Known pulmonary disease (to include respiratory infections)

结局指标

主要结局

Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine

时间窗: 2 minutes after mask placement

Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine

次要结局

  • Patient Discomfort (Verbal Numerical Rating Scale)(After study completion (approximately 2 minutes after study start))

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

Brooke Army Medical Center

研究点 (2)

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