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临床试验/NCT02768246
NCT02768246已完成不适用

Comparison of the Efficacy of a Bag-Valve-Guedel Adaptor to the Commonly Used Face Mask in Healthy Bearded Volunteers

Hebrew University of Jerusalem0 个研究点目标入组 25 人开始时间: 2016年6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
25
主要终点
End tidal CO2 levels (EtCO2)

研究概览

简要总结

Ventilation of a bearded patient with the commonly used face mask has low efficiency because of difficulties to achieve a tight seal around the mouth and nose.

The purpose of this study is to evaluate the efficacy of a novel bag valve guedel adaptor (BVGA) that enables the direct connection of a bag valve device to a guedel - eliminating the need for a face mask.

详细描述

Ventilating a patient using a bag valve and a face mask is not easy to perform, especially for a long period of time, and mandates experience and strength by the care giver. The need for a tight seal around the mouth and nose is a major challenge especially if the patient has a beard. Nevertheless, the face mask is the only approved respiratory support that medics and other basic care givers are allowed to use in the out-of-the-hospital setting, and only physicians and paramedics are allowed to use more advanced techniques, providing a definite airways. Thus, despite its lower effectiveness, the bag valve mask technique is the most commonly used in the field

The purpose of this study is to evaluate the efficacy of a novel bag valve guedel adaptor (BVGA) that enables the direct connection of a bag valve device to a guedel - eliminating the need for a face mask.

Study Design: Prospective, randomized, controlled. The volunteers will be asked randomly assigned to breathe through the BVGA/Face mask followed by the same protocol with the Face-mask/BVGA: 5 minutes room air, 5 minutes 100% oxygen, and 5 minutes room air again. The BVGAs/face masks well be connected to a standard operating room ventilation machines, and cardiopulmonary parameters will be monitored and documented.

研究设计

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

入排标准

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

入选标准

  • Healthy males more than 18 years of age.
  • 22 with beards, 3 without beards.

排除标准

  • Presence of facial fractures or injuries.
  • Claustrophobia.
  • Respiratory diseases.
  • Severe illness such as cardiac or neurological diseases.

结局指标

主要结局

End tidal CO2 levels (EtCO2)

时间窗: 30 minutes

EtCO2 will be monitored while the volunteer breathes through the BVGA or the face mask.

次要结局

  • End tidal O2 (EtO2)(30 minutes)

研究者

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

Lilach Gavish

Study Director

Hebrew University of Jerusalem

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