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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
102
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."
Brown Physicians, Inc
Providence, Rhode Island, United States
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.
Time frame: 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.
Time frame: 10 hours of manual ventilation
Secondary Outcome Measure
Secondary endpoints include: tidal volume, peak inspiratory pressure, respiratory rate, and estimated alveolar ventilation while ventilating the simulated lung.
Time frame: 10 hours of manual ventilation
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