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

NCT02768246 | Completed

• 1 other identifier: 0051-16-HMO
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pre-hospital Ventilation

Outcome Measures

Primary Outcomes (1)

• End tidal CO2 levels (EtCO2)

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

  30 minutes

Secondary Outcomes (1)

• End tidal O2 (EtO2)

  30 minutes

Study Arms (2)

Begin with BVGA

ACTIVE COMPARATOR

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; Device: Face Mask

Begin with Face-mask

ACTIVE COMPARATOR

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; Device: Face Mask

Interventions

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

Also known as: Bag Valve Guedel Adaptor

Begin with BVGA; Begin with Face-mask

Face Mask DEVICE

Classic face mask

Begin with BVGA; Begin with Face-mask

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hebrew University of Jerusalem: lead
• Hadassah Medical Organization: collaborator

Related Publications (1)

• 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.

  PMID: 33444455 DERIVED

MeSH Terms

Interventions

Masks

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ruth Shaylor, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• Lilach Gavish, PhD

  Hebrew University of Jerusalem

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 11, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share