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Completed

NCT Number: NCT02768246

Comparison of Bag-Valve-Guedel Adaptor to Common Face Mask for the Ventilation of Bearded Men

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

BVGA

Device

The BVGA enables the direct connection of a bag valve device to a guedel, eliminating the need for a face mask during ventilation

Other names: Bag Valve Guedel Adaptor

face mask

Device

Classic face mask

Primary outcomes

  1. End tidal CO2 levels (EtCO2)

    Time frame: 30 minutes

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

Secondary outcomes

  1. End tidal O2 (EtO2)

    Time frame: 30 minutes

    EtO2 will be monitored while the volunteer breathes through the BVGA or the face mask.

Sponsors and collaborators

Lead sponsor

Hebrew University of Jerusalem

Other

Collaborators

  • Hadassah Medical Organization

Registry information

Official study title

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

Acronym: BVGA01

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 11, 2016
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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