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

Non-inferiority Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation in Patients Undergoing Non-emergent Surgery With General Anesthesia

Who can join

Ages 18 to 80 · All sexes

Inclusion Criteria:

* 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 Criteria:

* ASA PS \>3 (e.g., respiratory disease)
* Oropharyngeal or facial pathology

About the study

Effective respiratory ventilation is achieved by moving the right amount of air in 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 non-inferiority study, we will perform a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation.

What is being tested

• ADULT Sotair Device (device)

Sponsor: Rhode Island Hospital · Participants: 310 · Started: Dec 20, 2023

Contact the study team

• Stephanie Farias · Phone: 401-444-5172

Official record on ClinicalTrials.gov — NCT06117683

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.