Bag-Valve-Guedel Adaptor vs Common Face Mask for the Ventilation of Anesthetized Bearded Men (BVGA02)

Evaluating the Safety and Efficacy of the Bag-Valve-Guedel Adaptor in Anesthetized Bearded Men in Comparison to the Standard Face Mask - A Prospective, Randomized Cross-over Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Ventilation
• Intervention / Treatment: Device: Begin with BVGA; Device: Begin with 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 airway. Thus, despite its lower effectiveness, the bag valve mask technique is the most commonly used in the field. We have shown previously that the BVGA provides significantly more efficient (less leak) ventilation compared to a facemask, in a randomized, cross-over (BVGA vs mask) controlled clinical trial (NCT02768246) with healthy bearded volunteers that were awake and breathed spontaneously.

The purpose of this study is to evaluate the safety and efficacy of the BVGA compared to a classic facemask in anesthetized bearded volunteers.

Study Design:

Prospective, randomized (sequence randomization), controlled (cross over). The study population will include ASA 1 or 2patients that are planned to undergo elective surgery under general anesthesia with non-depolarizing muscle relaxants. These will include 45 men with beards, and 14 men without beards or women

All subjects will sign an informed consent before participation and will be randomized by sequence (BVGA followed by Mask or Mask followed by BVGA). The physician will initiate anesthesia induction with a face mask according to normal procedures. Experimental phase: According to the sequence of devices determined in the randomization, the physician will then place the first device for 2 minutes, and then replace it with the second device for 2 minutes. The devices will be connected to the operating ventilation machines and physiological and respiratory parameters will be monitored continuously. During the experimental phase, a study assistant will note if the physician used 1 or 2 hands during the ventilation with the experimental devices (BVGA/mask).

The physician will then continue the anesthesia procedures as planned. The physician will complete a questionnaire related to the use of the BVGA in comparison to the standard mask.

• Study Type: Interventional
• Enrollment (Anticipated): 59
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lilach Gavish, PhD; Phone Number: +97226758623; Email: lilachg@ekmd.huji.ac.il

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Haddasah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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; 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; 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; 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; 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
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 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. The second minute of each of the interventions will be used for the data analysis.	2 minutes
Ease of use	The number of hands (1 or 2) the physician had to use during the ventilation procedure while using each device (mask or BVGA)	30 minutes

Collaborators and Investigators

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

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): April 1, 2021
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: ventilation; airway management; intubation; emergency responders
• Other Study ID Numbers: 0172-20-HMO

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No