Could a simple valve make manual ventilation safer during surgery?
NCT ID NCT06261619
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This trial compares a disposable safety device called the Adult Sotair, which limits airflow, against standard manual ventilation in adults undergoing non-emergency surgery with general anesthesia. The goal is to see if the device helps keep airway pressures at safer levels. Thirty participants will be randomly assigned to receive both methods in a crossover design.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Adult Sotair device (a disposable flow-limiting valve attached to a manual resuscitator)
- What this could lead to
- If effective, the Sotair device could become a standard safety tool to prevent lung injury during manual ventilation in surgery.
- What could go wrong
- This is a small, early-stage trial with only 30 participants, so results may not apply broadly. The device may not show meaningful improvement over standard manual ventilation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
-
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
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