Enrolling by invitation NCT06805838
Prolonged Manual Ventilation Simulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sotair.
- Who it may be relevant to
- Registry conditions: Manual Ventilation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- 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."
Primary outcome measures
- Minute ventilation while manually ventilating the simulated lung [Time frame: 10 hours of manual ventilation]
- Minute ventilation while manually ventilating the simulated lung [Time frame: 10 hours of manual ventilation]
Secondary outcome measures (1)
- Secondary Outcome Measure [Time frame: 10 hours of manual ventilation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Brown Physicians, Inc — Providence
Identifiers
NCT: NCT06805838 · DoD Ventilation Study · HT94252310316