ApneaNCT02792049
Ventilation Using a Bag Valve Mask With Integrated Internal Handle
A study testing Modified Ambu Spur II bag valve mask and Conventional Ambu Spur II bag valve mask in people with Apnea, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
Investigators compared tidal volumes for single rescuer ventilation using a modified bag valve mask with an integrated internal handle versus a conventional bag valve mask in a manikin model. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Apnea
- What is being tested?
- Modified Ambu Spur II bag valve mask and Conventional Ambu Spur II bag valve mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Emergency Department healthy volunteers (physician assistants, residents, paramedics, nurses, medics, respiratory therapists.
Who cannot join
- Not trained in basic life support
Trial locations and contacts
1 site in 1 country.
United States1 site
San Antonio Military Medical Center
San Antonio, Texas, 78234
About this study
Official title: Single Rescuer Ventilation Using a Bag Valve Mask With Integrated Internal Handle Versus Standard Bag Valve Mask in a Manikin Model: A Randomized Crossover Trial
Investigators compared tidal volumes for single rescuer ventilation using a modified bag valve mask with an integrated internal handle versus a conventional bag valve mask in a manikin model.
Read the detailed description
This was a prospective, randomized, crossover study to assess the tidal volume delivered using a standard and modified bag valve mask (BVM) device in a manikin airway model. Data was collected from July 2015 through October 2015 at the San Antonio Military Medical Center. Emergency medicine providers (physicians, physician assistants, residents, nurses, medics) were randomized to device order. Prior to participation each participant filled out a survey indicating their job status, gender, years of medical experience, and experience level with BVM ventilation. Hand grip strength and size (length, width, span) were measured. Each participant was then asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters. After a 3 minute rest period, testing was repeated with the second device. After ventilation with each device, participants completed an anonymous questionnaire that used a Likert scale to assess perceived qualities of the modified device including ease of use, ability to provide a superior mask seal, willingness to use in an emergency situation, and overall preference between the two devices. Each participant served as his/her own control.
- Conditions
- Apnea
- Being tested
- Modified Ambu Spur II bag valve mask, Conventional Ambu Spur II bag valve mask
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Ambu Spur II bag valve maskDevice
Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with integrated internal handle
Conventional Ambu Spur II bag valve maskDevice
Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask
| Study group | Role | What they receive |
|---|---|---|
| Modified Ambu Spur II bag valve mask | Experimental | A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). Receives: Device: Modified Ambu Spur II bag valve mask |
| Conventional Ambu Spur II bag valve mask | Active comparator | A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). Receives: Device: Conventional Ambu Spur II bag valve mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Received Tidal Volume
Each participant was asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters
Measured: 3 minutes
Secondary outcomes (4)
Modified Bag Valve Mask (BVM) Ease of Use
Likert scale measuring subject's perceived ease of use of the modified BVM device from not at all easy to use (1) to very easy to use (5).
Measured: Within 10 minutes of study completion
Modified Bag Valve Mask (BVM) Better Seal Formation
Subjects response using a Likert scale (1-5) regarding their perceptions of whether the modified BVM forms a better seal compared to a standard BVM: 1 (much worse seal formation) to 5 (much better seal formation).
Measured: Within 10 minutes of study completion
Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation
Subject reported willingness to use the modified BVM in a real life emergency situation as measured on a Likert scale ranging 1 (not at all willing to use) to 5 (very willing to use).
Measured: Within 10 minutes of study completion
Number of Participants Who Preferred the Modified Bag Valve Mask (BVM)
Each subject provides a binary response as to whether he/she overall prefers using the modified BVM instead of the conventional BVM.
Measured: Within 10 minutes of study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ApneaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Michael D. April, Brooke Army Medical Center
- Investigators
- Michael D April, MD, DPhil, Study director, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792049
- Sponsor's protocol ID
- C.2015.046e
- Status last verified
- Sep 2016
- First submitted
- 31 May 2016
- Last updated
- 25 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Davidovic L, LaCovey D, Pitetti RD. Comparison of 1- versus 2-person bag-valve-mask techniques for manikin ventilation of infants and children. Ann Emerg Med. 2005 Jul;46(1):37-42. doi: 10.1016/j.annemergmed.2005.02.005.
PubMed 15988424Braude DA, Tawil I, Gerstein NS, Carey MC, Petersen TR. Comparison of bag-valve-mask hand-sealing techniques in a simulated model. Ann Emerg Med. 2014 Jun;63(6):784-5. doi: 10.1016/j.annemergmed.2014.01.037. No abstract available.
PubMed 24841402Otten D, Liao MM, Wolken R, Douglas IS, Mishra R, Kao A, Barrett W, Drasler E, Byyny RL, Haukoos JS. Comparison of bag-valve-mask hand-sealing techniques in a simulated model. Ann Emerg Med. 2014 Jan;63(1):6-12.e3. doi: 10.1016/j.annemergmed.2013.07.014. Epub 2013 Aug 9.
PubMed 23937957Amack AJ, Barber GA, Ng PC, Smith TB, April MD. Comparison of Ventilation With One-Handed Mask Seal With an Intraoral Mask Versus Conventional Cuffed Face Mask in a Cadaver Model: A Randomized Crossover Trial. Ann Emerg Med. 2017 Jan;69(1):12-17. doi: 10.1016/j.annemergmed.2016.04.017. Epub 2016 May 27.
PubMed 27238825
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Rescuer Ventilation Using a Bag Valve Mask With Integrated Internal Handle Versus Standard Bag Valve Mask in a Manikin Model: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT02792049
- Acronym / sponsor ID
- C.2015.046e
- Conditions
- Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Posted 25 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators compared tidal volumes for single rescuer ventilation using a modified bag valve mask with an integrated internal handle versus a conventional bag valve mask in a manikin model.
Detailed description
This was a prospective, randomized, crossover study to assess the tidal volume delivered using a standard and modified bag valve mask (BVM) device in a manikin airway model. Data was collected from July 2015 through October 2015 at the San Antonio Military Medical Center. Emergency medicine providers (physicians, physician assistants, residents, nurses, medics) were randomized to device order. Prior to participation each participant filled out a survey indicating their job status, gender, years of medical experience, and experience level with BVM ventilation. Hand grip strength and size (length, width, span) were measured. Each participant was then asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters. After a 3 minute rest period, testing was repeated with the second device. After ventilation with each device, participants completed an anonymous questionnaire that used a Likert scale to assess perceived qualities of the modified device including ease of use, ability to provide a superior mask seal, willingness to use in an emergency situation, and overall preference between the two devices. Each participant served as his/her own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Ambu Spur II bag valve mask | Experimental | Device: Modified Ambu Spur II bag valve maskA health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). |
| Conventional Ambu Spur II bag valve mask | Active comparator | Device: Conventional Ambu Spur II bag valve maskA health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Emergency Department healthy volunteers (physician assistants, residents, paramedics, nurses, medics, respiratory therapists.
Key exclusion criteria (1 listed)
- Not trained in basic life support
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 |
|---|---|---|
| Modified Ambu Spur II bag valve maskSubjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with integrated internal handle | Device | Modified Ambu Spur II bag valve mask |
| Conventional Ambu Spur II bag valve maskSubjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask | Device | Conventional Ambu Spur II bag valve mask |
Primary outcome
Mean Received Tidal Volume
Time frame: 3 minutes
Each participant was asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters
4 secondary outcomes
Modified Bag Valve Mask (BVM) Ease of Use
Time frame: Within 10 minutes of study completion
Modified Bag Valve Mask (BVM) Better Seal Formation
Time frame: Within 10 minutes of study completion
Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation
Time frame: Within 10 minutes of study completion
Number of Participants Who Preferred the Modified Bag Valve Mask (BVM)
Time frame: Within 10 minutes of study completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15988424Davidovic L, LaCovey D, Pitetti RD. Comparison of 1- versus 2-person bag-valve-mask techniques for manikin ventilation of infants and children. Ann Emerg Med. 2005 Jul;46(1):37-42. doi: 10.1016/j.annemergmed.2005.02.005.
- Background: PubMed 24841402Braude DA, Tawil I, Gerstein NS, Carey MC, Petersen TR. Comparison of bag-valve-mask hand-sealing techniques in a simulated model. Ann Emerg Med. 2014 Jun;63(6):784-5. doi: 10.1016/j.annemergmed.2014.01.037. No abstract available.
- Background: PubMed 23937957Otten D, Liao MM, Wolken R, Douglas IS, Mishra R, Kao A, Barrett W, Drasler E, Byyny RL, Haukoos JS. Comparison of bag-valve-mask hand-sealing techniques in a simulated model. Ann Emerg Med. 2014 Jan;63(1):6-12.e3. doi: 10.1016/j.annemergmed.2013.07.014. Epub 2013 Aug 9.
- Background: PubMed 27238825Amack AJ, Barber GA, Ng PC, Smith TB, April MD. Comparison of Ventilation With One-Handed Mask Seal With an Intraoral Mask Versus Conventional Cuffed Face Mask in a Cadaver Model: A Randomized Crossover Trial. Ann Emerg Med. 2017 Jan;69(1):12-17. doi: 10.1016/j.annemergmed.2016.04.017. Epub 2016 May 27.
- Individual participant dataSharing planned: No
Related trials for Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Not yet recruiting
Comparing Two Types of Breathing Support in People With COPD, High Carbon Dioxide Levels, and Sleep Apnea
OSA COPD Overlap Syndrome
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
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.
Michael D April, MD, DPhil study director
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Ambu Spur II bag valve mask and Conventional Ambu Spur II bag valve mask in people with Apnea, run by Brooke Army Medical Center at 1 site in United States.
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 1 inclusion and 1 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 25 Oct 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Received Tidal Volume (time frame: 3 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 NCT02792049, which also lists 4 linked publications.
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 25 Oct 2016.