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
| Registry | NCT04376918, acronym BVGA02 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: none, supportive care |
| Enrollment | 101 (Actual) |
| Sponsor | Hebrew University of Jerusalem (Other); collaborators: Hadassah Medical Organization |
| Conditions | Ventilation |
| Interventions | Begin with BVGA, Begin with Face-mask (Device) |
| Dates | start 2021-04-01, primary completion 2023-01-31, completion 2023-07-31, first posted 2020-05-06, last updated 2025-03-12 |
| Locations | 1 site in Israel |
Related Papers Related Patents Related Grants Related Experts
All trials for Ventilation All trials of Begin with BVGA All trials of Begin with Face-mask
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Begin with BVGA | Active comparator | Device: 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 |
| Begin with Face-mask | Active comparator | Device: 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 |
Sex: All, ages: 18 Years to 70 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Haddasah Medical Center | Jerusalem | Israel |