Trials / Enrolling By Invitation
Enrolling By InvitationNCT06805838
Prolonged Manual Ventilation Simulation
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- Sponsor
- SafeBVM · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sotair | 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." |
Timeline
- Start date
- 2025-01-25
- Primary completion
- 2026-01-31
- Completion
- 2026-07-31
- First posted
- 2025-02-03
- Last updated
- 2025-08-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06805838. Inclusion in this directory is not an endorsement.