Sotair® Device for Airway Management During Non-Emergency Surgery
This study is testing a new disposable device called Adult Sotair® that attaches to a manual resuscitator (a bag used to help someone breathe). The goal is to see if this device can deliver air to the lungs as safely and effectively as a mechanical ventilator, by keeping airway pressures at a safe level. We are looking for adults aged 18 to 80 who are having non-emergency surgery with general anesthesia at Rhode Island Hospital and are in good health (ASA physical status 1 or 2). The main thing we'll be looking at is the peak airway pressure (how much pressure is in your lungs when air is pushed in) for three minutes during the study. The current status of this study is unclear.
- Study design
- This study will involve about 310 participants. It uses a "pre-post" design, meaning each participant will be compared to themselves, using both the Sotair® device and mechanical ventilation.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, peak airway pressure, is measured for a 3-minute duration for each arm of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mark Kendall, MD · PRINCIPAL_INVESTIGATOR · Rhode Island Hospital
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Peak airway pressureRecorded for 3 minute duration for each arm of the study
mean peak airway pressure expressed in cm H20