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临床试验/NCT02800213
NCT02800213已完成不适用

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

Brooke Army Medical Center0 个研究点目标入组 70 人开始时间: 2016年5月最近更新:
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
70
主要终点
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 a supplemental external 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. The modified device comprised a standard bag valve mask with supplemental external bar. Data was collected during May 2016 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 (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

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

研究组 & 干预措施

Conventional Ambu Spur II bag mask first

Active Comparator

A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). Volunteer then repeats the procedures using a modified Ambu Spur II bag valve mask.

干预措施: Modified Ambu Spur II bag valve mask (Device)

Modified Ambu Spur II bag mask first

Experimental

A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). Volunteer then repeats the procedures using a conventional Ambu Spur II bag valve mask.

干预措施: Modified Ambu Spur II bag valve mask (Device)

Modified Ambu Spur II bag mask first

Experimental

A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). Volunteer then repeats the procedures using a conventional Ambu Spur II bag valve mask.

干预措施: Conventional Ambu Spur II bag valve mask (Device)

Conventional Ambu Spur II bag mask first

Active Comparator

A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). Volunteer then repeats the procedures using a modified Ambu Spur II bag valve mask.

干预措施: Conventional Ambu Spur II bag valve mask (Device)

结局指标

主要结局

Received Tidal Volume

时间窗: 3 minutes

Mean received tidal volume for 30 breaths delivered by the subjects over three minutes as measured via the RespiTrainer Advance manikin model monitor output.

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 Director for Research, Emergency Medicine Residency

Brooke Army Medical Center

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