Comparison of Bag-Valve-Guedel Adaptor to Common Face Mask for the Ventilation of Bearded Men (BVGA01)

H

Hebrew University of Jerusalem

Status

Completed

Conditions

Pre-hospital Ventilation

Treatments

Device: Face Mask
Device: BVGA

Study type

Interventional

Funder types

Other

Identifiers

NCT02768246
0051-16-HMO

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

25 participants in 2 patient groups

Begin with BVGA
Active Comparator group
Description:
The volunteers will be asked to breathe 5 minutes of room air through the BVGA, followed by, 5 minutes 100% oxygen, and 5 minutes room air again. This will be followed by 5 minutes room air breathing without the BVGA. Then the same volunteers will be asked to repeat the protocol with the face mask.
Treatment:
Device: BVGA
Device: Face Mask
Begin with Face-mask
Active Comparator group
Description:
The volunteers will be asked to breathe 5 minutes of room air through the face mask, followed by, 5 minutes 100% oxygen, and 5 minutes room air again. This will be followed by 5 minutes room air breathing without the face mask. Then the same volunteers will be asked to repeat the protocol with the BVGA.
Treatment:
Device: BVGA
Device: Face Mask

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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