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

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

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.

Study Overview

• Status: Completed
• Conditions: Pre-hospital Ventilation
• Intervention / Treatment: Device: BVGA; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Begin with BVGA; 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.	Device: BVGA; 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; Device: Face Mask; Classic face mask
Active Comparator: Begin with Face-mask; 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.	Device: BVGA; 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; Device: Face Mask; Classic face mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End tidal CO2 levels (EtCO2)	EtCO2 will be monitored while the volunteer breathes through the BVGA or the face mask.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End tidal O2 (EtO2)	EtO2 will be monitored while the volunteer breathes through the BVGA or the face mask.	30 minutes

Collaborators and Investigators

• Sponsor: Hebrew University of Jerusalem
• Collaborators: Hadassah Medical Organization
• Investigators: Study Director: Lilach Gavish, PhD, Hebrew University of Jerusalem; Principal Investigator: Ruth Shaylor, MD, Hadassah Medical Organization

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 0051-16-HMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No