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临床试验/NCT02792049
NCT02792049已完成不适用

Single Rescuer Ventilation Using a Bag Valve Mask With Integrated Internal Handle Versus Standard Bag Valve Mask in a Manikin Model: A Randomized Crossover Trial

Brooke Army Medical Center2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年7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
70
试验地点
2
主要终点
Mean Received Tidal Volume

研究概览

简要总结

Investigators compared tidal volumes for single rescuer ventilation using a modified bag valve mask with an integrated internal handle versus a conventional bag valve mask in a manikin model.

详细描述

This was a prospective, randomized, crossover study to assess the tidal volume delivered using a standard and modified bag valve mask (BVM) device in a manikin airway model. Data was collected from July 2015 through October 2015 at the San Antonio Military Medical Center. Emergency medicine providers (physicians, physician assistants, residents, nurses, medics) were randomized to device order. Prior to participation each participant filled out a survey indicating their job status, gender, years of medical experience, and experience level with BVM ventilation. Hand grip strength and size (length, width, span) were measured. Each participant was then asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters. After a 3 minute rest period, testing was repeated with the second device. After ventilation with each device, participants completed an anonymous questionnaire that used a Likert scale to assess perceived qualities of the modified device including ease of use, ability to provide a superior mask seal, willingness to use in an emergency situation, and overall preference between the two devices. Each participant served as his/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
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

  • Emergency Department healthy volunteers (physician assistants, residents, paramedics, nurses, medics, respiratory therapists.

排除标准

  • Not trained in basic life support

结局指标

主要结局

Mean Received Tidal Volume

时间窗: 3 minutes

Each participant was asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters

次要结局

  • Modified Bag Valve Mask (BVM) Better Seal Formation(Within 10 minutes of study completion)
  • Number of Participants Who Preferred the Modified Bag Valve Mask (BVM)(Within 10 minutes of study completion)
  • Modified Bag Valve Mask (BVM) Ease of Use(Within 10 minutes of study completion)
  • Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation(Within 10 minutes of study completion)

研究者

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

Michael D. April

Assistant Director for Research, Emergency Medicine Residency

Brooke Army Medical Center

研究点 (2)

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