VentilationBVGA02NCT04376918
Bag-Valve-Guedel Adaptor Vs Common Face Mask for the Ventilation of Anesthetized Bearded Men
A study testing Begin with BVGA and Begin with Face-mask in people with Ventilation, run by Hebrew University of Jerusalem at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ventilation
- What is being tested?
- Begin with BVGA and Begin with Face-mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Ventilation
- Being tested
- Begin with BVGA, Begin with Face-mask
- Keywords
- ventilation, airway management, intubation, emergency responders
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Begin with BVGADevice
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-maskDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Begin with Face-mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 minutes
Secondary outcomes (2)
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.
Measured: 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)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Apr 2021
- Primary completion31 Jan 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, randomized (sequence randomization), controlled (cross over)
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Principal investigator, Lilach Gavish, Hebrew University of Jerusalem
- Investigators
- Shimon Firman, MD, Principal investigator, Hadassah Medical OrganizationLilach Gavish, PhD, Study director, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376918
- Sponsor's protocol ID
- 0172-20-HMO
- Acronym
- BVGA02
- Status last verified
- Mar 2025
- First submitted
- 4 May 2020
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33444455
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04376918
- Acronym / sponsor ID
- BVGA02 / 0172-20-HMO
- Conditions
- Ventilation
- Keywords
- ventilation, airway management, intubation, emergency responders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Collaborators
- Hadassah Medical Organization
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized (sequence randomization), controlled (cross over)
| Arm | Type | Receives |
|---|---|---|
| Begin with BVGA | Active comparator | Device: Begin with BVGAAfter 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-maskAfter 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Pregnant women
- ASA>2
- Presence of facial fractures or injuries.
- Expected to suffer from aspiration and requiring rapid sequence induction
- Edentulous or unstable teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Begin with BVGADevice: 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 | Device | Begin with BVGA |
| Begin with Face-maskDevice: 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 | Device | Begin with Face-mask |
Primary outcome
Tidal Volume
Time frame: 2 minutes
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 secondary outcomes
End tidal CO2 levels (EtCO2)
Time frame: 2 minutes
Ease of use
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 33444455Gavish 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.
- Individual participant dataSharing planned: No
Related trials for Ventilation
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shimon Firman, MD principal investigator
Hadassah Medical Organization
Lilach Gavish, PhD study director
Hebrew University of Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Begin with BVGA and Begin with Face-mask in people with Ventilation, run by Hebrew University of Jerusalem at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal Volume (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04376918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.