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

Ventilation Clinical Trial

— BVGA02  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376918
• Other study ID #: 0172-20-HMO
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Hebrew University of Jerusalem
• Contact: Lilach Gavish, PhD
• Phone: +97226758623
• Email: lilachg[@]ekmd.huji.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: December 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ventilation

Intervention

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
• 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

Locations

Country	Name	City	State
Israel	Haddasah Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hebrew University of Jerusalem	Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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