Bag-Valve-Guedel Adaptor Vs Common Face Mask for the Ventilation of Anesthetized Bearded Men

NCT04376918 | Completed

• 1 other identifier: 0172-20-HMO
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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 in anesthetized bearded men.

Conditions

Ventilation

Keywords

ventilation; airway management; intubation; emergency responders

Outcome Measures

Primary Outcomes (1)

• Tidal Volume

  Tidal volume will be monitored while the volunteer breathes through the BVGA or the face mask. The second minute of each of the interventions will be used for the data analysis.

  2 minutes

Secondary Outcomes (2)

• End tidal CO2 levels (EtCO2)

  2 minutes

• Ease of use

  30 minutes

Study Arms (2)

Begin with BVGA

ACTIVE COMPARATOR

After initial anesthesia induction, anesthetized volunteers will be ventilated through through the BVGA for 2 minutes and then through the face-mask for 2 minutes. The normal anesthesia procedures will then be resumed. The BVGA enables the direct connection of a bag valve device to a Guedel, eliminating the need for a face mask during ventilation The Mask is a classic face mask

Device: Begin with BVGA

Begin with Face-mask

ACTIVE COMPARATOR

After initial anesthesia induction, anesthetized volunteers will be ventilated through the face mask for 2 minutes and then through the BVGA for 2 minutes. The normal anesthesia procedures will then be resumed The BVGA enables the direct connection of a bag valve device to a Guedel, eliminating the need for a face mask during ventilation The Mask is a classic face mask

Device: Begin with Face-mask

Interventions

Begin with BVGA DEVICE

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

Begin with BVGA

Begin with Face-mask DEVICE

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

Begin with Face-mask

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Most volunteers are required to have a beard, therefore most volunteers will be men.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Beards men with different levels of beard fullness, men without beards, or women
• planned to undergo elective surgery with endotracheal intubation using non-depolarizing neuromuscular blocking agents
• ASA 1 or 2
• BMI ≤30

You may not qualify if:

• Pregnant women
• ASA\>2
• Presence of facial fractures or injuries.
• Expected to suffer from aspiration and requiring rapid sequence induction
• Edentulous or unstable teeth
• Morbid obesity
• Suspected difficult intubation
• Suspected difficult ventilation (except of the presence of beard)
• If an unexpected difficulty in ventilation will arise during induction, patient will be excluded from study.
• Worker from Hadassah Medical Center

Sponsors & Collaborators

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

Study Sites (1)

Haddasah Medical Center

Jerusalem, Israel

Location

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 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Masks

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• Shimon Firman, 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

Model Details: Prospective, randomized (sequence randomization), controlled (cross over)

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Study Start: April 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: July 31, 2023
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)