Clinical trial NCT02768246: Comparison of Bag-Valve-Guedel Adaptor to Common Face Mask for the Ventilation of Bearded Men
Official title: Comparison of the Efficacy of a Bag-Valve-Guedel Adaptor to the Commonly Used Face Mask in Healthy Bearded Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-hospital Ventilation
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
Collaborators: name: Hadassah Medical Organization
First posted: 2016-05-11
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: End tidal CO2 levels (EtCO2)
timeFrame: 30 minutes
Secondary outcomes:
measure: End tidal O2 (EtO2)
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Ruth Shaylor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebrew University of Jerusalem
name: Lilach Gavish, PhD
role: STUDY_DIRECTOR
References:
citation: Gavish L, Rittblat M, Gertz SD, Shaylor R, Weissman C, Eisenkraft A. Ventilating the Bearded: A Randomized Crossover Trial Comparing a Novel Bag-Valve-Guedel Adaptor to a Standard Mask. Mil Med. 2020 Aug 14;185(7-8):e1300-e1308. doi: 10.1093/milmed/usz378.