Manual VentilationNCT06805838
Prolonged Manual Ventilation Simulation
A study testing Sotair in people with Manual Ventilation, run by SafeBVM at 1 site in United States.
Trial summary
A pilot study on simulated lung scenarios using the standard manual resuscitator bag, flow limiting resuscitator bag, and an FDA approved flow rate limiting device paired with a standard manual resuscitator. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Manual Ventilation
- What is being tested?
- Sotair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years old or older
- Have a current basic life support (BLS) certification
- Be available for the entire 10 hours to complete the protocol
Who cannot join
- Any training in medical school or respiratory therapy school
- Not being available for the full 10 hours to complete the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brown Physicians, Inc
Providence, Rhode Island, 02903
About this study
A pilot study on simulated lung scenarios using the standard manual resuscitator bag, flow limiting resuscitator bag, and an FDA approved flow rate limiting device paired with a standard manual resuscitator.
- Conditions
- Manual Ventilation
- Being tested
- Sotair
- Keywords
- Prolonged manual ventilation simulation, BVM, Sotair, BLS certification, tidal volume, peak inspiratory pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotairDevice
The device is a durable plastic connector with a silicone flap inside it requiring no special handling. There are no patients involved, only a simulated lung that also requires no special handling. Adult Sotair® device has FDA clearance as a Class II device through the 510(k) pathway (K212905) for the intended use of "Flow-limiting, safe, and optimal manual ventilation to minimize gastric insufflation."
| Study group | Role | What they receive |
|---|---|---|
| Ambu + Normal lung compliance | No intervention | Manual ventilation with Ambu bag and normal lung compliance. |
| Ambu + Low lung compliance | No intervention | Manual ventilation with Ambu bag and low lung compliance. |
| Smart bag + Normal lung compliance | No intervention | Manual ventilation with smart bag and normal lung compliance. |
| Smart bag + Low lung compliance | No intervention | Manual ventilation with smart bag and low lung compliance. |
| Ambu + Sotair + Normal lung compliance | Active comparator | Manual ventilation with Ambu bag and Sotair device with normal lung compliance. Receives: Device: Sotair |
| Ambu + Sotair + Low compliance | Active comparator | Manual ventilation with Ambu bag and Sotair device with low lung compliance. Receives: Device: Sotair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minute ventilation while manually ventilating the simulated lung
The primary Ventilation endpoint is minute ventilation while manually ventilating the simulated lung over the course of 10 hours.
Measured: 10 hours of manual ventilation
Minute ventilation while manually ventilating the simulated lung
The major endpoints of the subjects response to performing the manual ventilation will be: Respiratory rate and heart rate; Samn-Perelli 7-point fatigue scale reported hourly; Modified Borg Rating of Perceived Exertion 10-point scale reported hourly.
Measured: 10 hours of manual ventilation
Secondary outcomes (1)
Secondary Outcome Measure
Secondary endpoints include: tidal volume, peak inspiratory pressure, respiratory rate, and estimated alveolar ventilation while ventilating the simulated lung.
Measured: 10 hours of manual ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start25 Jan 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manual 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SafeBVM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Mark Brady, MD, Principal investigator, Brown Physicians, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805838
- Sponsor's protocol ID
- DoD Ventilation Study
- Other IDs
- HT94252310316
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Decision has not been determined.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Manual Ventilation Simulation
- ClinicalTrials.gov ID
- NCT06805838
- Acronym / sponsor ID
- DoD Ventilation Study
- Conditions
- Manual Ventilation
- Keywords
- Prolonged manual ventilation simulation, BVM, Sotair, BLS certification, tidal volume, peak inspiratory pressure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- SafeBVMIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 3 Feb 2025 (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.
A pilot study on simulated lung scenarios using the standard manual resuscitator bag, flow limiting resuscitator bag, and an FDA approved flow rate limiting device paired with a standard manual resuscitator.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Ambu + Normal lung compliance | No intervention | –Manual ventilation with Ambu bag and normal lung compliance. |
| Ambu + Low lung compliance | No intervention | –Manual ventilation with Ambu bag and low lung compliance. |
| Smart bag + Normal lung compliance | No intervention | –Manual ventilation with smart bag and normal lung compliance. |
| Smart bag + Low lung compliance | No intervention | –Manual ventilation with smart bag and low lung compliance. |
| Ambu + Sotair + Normal lung compliance | Active comparator | Device: SotairManual ventilation with Ambu bag and Sotair device with normal lung compliance. |
| Ambu + Sotair + Low compliance | Active comparator | Device: SotairManual ventilation with Ambu bag and Sotair device with low lung compliance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or older
- Have a current basic life support (BLS) certification
- Be available for the entire 10 hours to complete the protocol
Key exclusion criteria (2 listed)
- Any training in medical school or respiratory therapy school
- Not being available for the full 10 hours to complete the protocol
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 |
|---|---|---|
| SotairThe device is a durable plastic connector with a silicone flap inside it requiring no special handling. There are no patients involved, only a simulated lung that also requires no special handling. Adult Sotair® device has FDA clearance as a Class II device through the 510(k) pathway (K212905) for the intended use of "Flow-limiting, safe, and optimal manual ventilation to minimize gastric insufflation." | Device | Ambu + Sotair + Low compliance, Ambu + Sotair + Normal lung compliance |
Primary outcome
Minute ventilation while manually ventilating the simulated lung
Time frame: 10 hours of manual ventilation
The primary Ventilation endpoint is minute ventilation while manually ventilating the simulated lung over the course of 10 hours.
Minute ventilation while manually ventilating the simulated lung
Time frame: 10 hours of manual ventilation
The major endpoints of the subjects response to performing the manual ventilation will be: Respiratory rate and heart rate; Samn-Perelli 7-point fatigue scale reported hourly; Modified Borg Rating of Perceived Exertion 10-point scale reported hourly.
1 secondary outcome
Secondary Outcome Measure
Time frame: 10 hours of manual ventilation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Undecided. Decision has not been determined.
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.
Mark Brady, MD principal investigator
Brown Physicians, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sotair in people with Manual Ventilation, run by SafeBVM 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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 28 Aug 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Minute ventilation while manually ventilating the simulated lung (time frame: 10 hours of manual ventilation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.