An interventional study of Adult Sotair Device in Airway Management and Respiration, Artificial, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Supportive care
Effective respiratory ventilation is achieved by moving the right amount of air to and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.
Poor manual ventilation technique is a well-documented problem which occurs irrespective of a provider's qualifications or experience. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery among providers. The device is attached to a manual resuscitator and employs a flow limiting valve mechanism to minimize excessive pressure in the airway system without venting air by capping peak flow rates at 55 L/min. For an average adult with normal lung compliance and resistance, this corresponds to a maximum airway pressure of approximately 20 cmH2O which minimizes air entry into the stomach. In this superiority study (margin 7.5 cm H20), the investigators will use a two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone with respect to airway pressure.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's enrollment of 30 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds.
Device: Adult Sotair Device
The anesthesia provider will manually bag ventilate for 3 minutes with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds.
Adult Sotair® device employs a flow limiting valve mechanism.
Also known as: Sotair, SafeBVM
Peak airway pressure
Mean of the maximum peak airway pressures expressed in cm H2O
Time frame: Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study
Tidal volume
The amount of air that moves to or out of the lungs with each respiratory cycle. Measured in mL. Mean of the maximum tidal volumes every 30 seconds.
Time frame: Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study
Airflow
Represents the volume of air moved per unit of time during inspiration and expiration. Measured (L/min)
Time frame: Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study
Plan to share: Yes — The IPD that underlie the results in a publication will be shared with other researchers.
Supporting information: Sap
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rhode Island Hospital