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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02768246
Acronym
BVGA01
Enrollment
25
Registered
2016-05-11
Start date
2016-06-30
Completion date
2016-12-31
Last updated
2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-hospital Ventilation

Brief summary

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.

Detailed description

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.

Interventions

DEVICEBVGA

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

DEVICEFace Mask

Classic face mask

Sponsors

Hadassah Medical Organization
CollaboratorOTHER
Hebrew University of Jerusalem
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1. Healthy males more than 18 years of age. 2. 22 with beards, 3 without beards.

Exclusion criteria

1. Presence of facial fractures or injuries. 2. Claustrophobia. 3. Respiratory diseases. 4. Severe illness such as cardiac or neurological diseases.

Design outcomes

Primary

MeasureTime frameDescription
End tidal CO2 levels (EtCO2)30 minutesEtCO2 will be monitored while the volunteer breathes through the BVGA or the face mask.

Secondary

MeasureTime frameDescription
End tidal O2 (EtO2)30 minutesEtO2 will be monitored while the volunteer breathes through the BVGA or the face mask.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026