Pre-hospital VentilationBVGA01NCT02768246
Comparison of Bag-Valve-Guedel Adaptor to Common Face Mask for the Ventilation of Bearded Men
A study testing BVGA and Face Mask in people with Pre-hospital Ventilation, run by Hebrew University of Jerusalem.
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 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-hospital Ventilation
- What is being tested?
- BVGA and Face Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2016
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males more than 18 years of age.
- 22 with beards, 3 without beards.
Who cannot join
- Presence of facial fractures or injuries.
- Claustrophobia.
- Respiratory diseases.
- Severe illness such as cardiac or neurological diseases.
About this study
Official title: Comparison of the Efficacy of a Bag-Valve-Guedel Adaptor to the Commonly Used Face Mask in Healthy Bearded Volunteers
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.
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 airways. Thus, despite its lower effectiveness, the bag valve mask technique is the most commonly used in the field
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.
Study Design: Prospective, randomized, controlled. The volunteers will be asked randomly assigned to breathe through the BVGA/Face mask followed by the same protocol with the Face-mask/BVGA: 5 minutes room air, 5 minutes 100% oxygen, and 5 minutes room air again. The BVGAs/face masks well be connected to a standard operating room ventilation machines, and cardiopulmonary parameters will be monitored and documented.
- Conditions
- Pre-hospital Ventilation
- Being tested
- BVGA, Face Mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVGADevice
Also called Bag Valve Guedel Adaptor
The BVGA enables the direct connection of a bag valve device to a guedel, eliminating the need for a face mask during ventilation
Face MaskDevice
Classic face mask
| Study group | Role | What they receive |
|---|---|---|
| Begin with BVGA | Active comparator | The volunteers will be asked to breathe 5 minutes of room air through the BVGA, followed by, 5 minutes 100% oxygen, and 5 minutes room air again. This will be followed by 5 minutes room air breathing without the BVGA. Then the same volunteers will be asked to repeat the protocol with the face mask. Receives: Device: BVGA; Device: Face Mask |
| Begin with Face-mask | Active comparator | The volunteers will be asked to breathe 5 minutes of room air through the face mask, followed by, 5 minutes 100% oxygen, and 5 minutes room air again. This will be followed by 5 minutes room air breathing without the face mask. Then the same volunteers will be asked to repeat the protocol with the BVGA. Receives: Device: BVGA; Device: Face Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
End tidal CO2 levels (EtCO2)
EtCO2 will be monitored while the volunteer breathes through the BVGA or the face mask.
Measured: 30 minutes
Secondary outcomes (1)
End tidal O2 (EtO2)
EtO2 will be monitored while the volunteer breathes through the BVGA or the face mask.
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 posted11 May 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2016
- Study completionDec 2016
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 Pre-hospital 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
- Masking
- None (open label)
- Enrolment
- 25 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
- Ruth Shaylor, MD, Principal investigator, Hadassah Medical OrganizationLilach Gavish, PhD, Study director, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768246
- Sponsor's protocol ID
- 0051-16-HMO
- Acronym
- BVGA01
- Status last verified
- Feb 2017
- First submitted
- 10 May 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- 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 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of a Bag-Valve-Guedel Adaptor to the Commonly Used Face Mask in Healthy Bearded Volunteers
- ClinicalTrials.gov ID
- NCT02768246
- Acronym / sponsor ID
- BVGA01 / 0051-16-HMO
- Conditions
- Pre-hospital Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Collaborators
- Hadassah Medical Organization
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 May 2016 (estimated)
- 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.
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 airways. Thus, despite its lower effectiveness, the bag valve mask technique is the most commonly used in the field
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.
Study Design: Prospective, randomized, controlled. The volunteers will be asked randomly assigned to breathe through the BVGA/Face mask followed by the same protocol with the Face-mask/BVGA: 5 minutes room air, 5 minutes 100% oxygen, and 5 minutes room air again. The BVGAs/face masks well be connected to a standard operating room ventilation machines, and cardiopulmonary parameters will be monitored and documented.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Begin with BVGA | Active comparator | Device: BVGA, Device: Face MaskThe volunteers will be asked to breathe 5 minutes of room air through the BVGA, followed by, 5 minutes 100% oxygen, and 5 minutes room air again. This will be followed by 5 minutes room air breathing without the BVGA. Then the same volunteers will be asked to repeat the protocol with the face mask. |
| Begin with Face-mask | Active comparator | Device: BVGA, Device: Face MaskThe volunteers will be asked to breathe 5 minutes of room air through the face mask, followed by, 5 minutes 100% oxygen, and 5 minutes room air again. This will be followed by 5 minutes room air breathing without the face mask. Then the same volunteers will be asked to repeat the protocol with the BVGA. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy males more than 18 years of age.
- 22 with beards, 3 without beards.
Key exclusion criteria (4 listed)
- Presence of facial fractures or injuries.
- Claustrophobia.
- Respiratory diseases.
- Severe illness such as cardiac or neurological diseases.
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 |
|---|---|---|
| BVGAAlso: Bag Valve Guedel AdaptorThe BVGA enables the direct connection of a bag valve device to a guedel, eliminating the need for a face mask during ventilation | Device | Begin with BVGA, Begin with Face-mask |
| Face MaskClassic face mask | Device | Begin with BVGA, Begin with Face-mask |
Primary outcome
End tidal CO2 levels (EtCO2)
Time frame: 30 minutes
EtCO2 will be monitored while the volunteer breathes through the BVGA or the face mask.
1 secondary outcome
End tidal O2 (EtO2)
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 3 Mar 2017.
- Derived from this study: 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 Pre-hospital Ventilation
Enrolling by invitationObservational study
Pre-hospital Ventilation Clinical Study
Altered Mental Status, Sepsis
Recruiting
A New Portable Device for Non-invasive Ventilatory Support
Healthy, Respiratory Disease
Not yet recruitingObservational study
Calibration Study PREDICT - Prehospital Triage for Suspected Acute Coronary Syndrome Without ST-segment Elevation
Acute Coronary Syndrome Without ST Elevation on Electrocardiogram
Enrolling by invitationObservational study
The Medical Management in Patients Exposed to Weapons of Mass Destruction
Chemical Injury, Chemicals; Intoxication
Not yet recruitingObservational study
Quality of Cardiopulmonary Resuscitation Pre- and Intra Hospital
Cardiac Death, Cardiac Arrest
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.
Ruth Shaylor, MD principal investigator
Hadassah Medical Organization
Lilach Gavish, PhD study director
Hebrew University of Jerusalem
Questions about this trial
What is this clinical trial studying?
A study testing BVGA and Face Mask in people with Pre-hospital Ventilation, run by Hebrew University of Jerusalem.
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 2 inclusion and 4 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
End tidal CO2 levels (EtCO2) (time frame: 30 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 NCT02768246, 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 3 Mar 2017.