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Prolonged Manual Ventilation Simulation
Sponsor: SafeBVM
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2025-01-25
Completion Date
2026-07-31
Last Updated
2025-08-28
Healthy Volunteers
Yes
Conditions
Interventions
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."
Locations (1)
Brown Physicians, Inc
Providence, Rhode Island, United States