Clinical trial NCT04376918: Bag-Valve-Guedel Adaptor Vs Common Face Mask for the Ventilation of Anesthetized Bearded Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation
Keywords: ventilation
airway management
intubation
emergency responders
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
Collaborators: name: Hadassah Medical Organization
First posted: 2020-05-06
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, randomized (sequence randomization), controlled (cross over)
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tidal Volume
timeFrame: 2 minutes
Secondary outcomes:
measure: End tidal CO2 levels (EtCO2)
timeFrame: 2 minutes
measure: Ease of use
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Haddasah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Shimon Firman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebrew University of Jerusalem
name: Lilach Gavish, PhD
role: STUDY_DIRECTOR
References:
citation: 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.