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.

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NCT06117683

Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation

Recruiting
NAAges 18–80InterventionalSupportive care
Rhode Island Hospital
~310 participants
Updated 2025-07-11 on ClinicalTrials.gov
What's tested:ADULT Sotair Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak airway pressure
Measured over Recorded for 3 minute duration for each arm of the study
Airway Management
Respiration, Artificial
1 sites across 1 states
Rhode Island1
  • Mark Kendall, MD · PRINCIPAL_INVESTIGATOR · Rhode Island Hospital

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Eligibility criteria

Inclusion

Adult patients who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital.
American Society of Anesthesiologists physical status 1 and 2

Exclusion

ASA PS \>3 (e.g., respiratory disease)
Oropharyngeal or facial pathology
  • Peak airway pressureRecorded for 3 minute duration for each arm of the study

    mean peak airway pressure expressed in cm H20