Manual Ventilation
Conditions
Keywords
Prolonged manual ventilation simulation, BVM, Sotair, BLS certification, tidal volume, peak inspiratory pressure
Brief 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.
Interventions
DEVICESotair
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.
Sponsors
United States Department of Defense
SafeBVM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years old or older * Have a current basic life support (BLS) certification * Be available for the entire 10 hours to complete the protocol
Exclusion criteria
* Any training in medical school or respiratory therapy school * Not being available for the full 10 hours to complete the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minute ventilation while manually ventilating the simulated lung | 10 hours of manual ventilation | The primary Ventilation endpoint is minute ventilation while manually ventilating the simulated lung over the course of 10 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measure | 10 hours of manual ventilation | Secondary endpoints include: tidal volume, peak inspiratory pressure, respiratory rate, and estimated alveolar ventilation while ventilating the simulated lung. |
Countries
United States
Outcome results
None listed