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

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.

NCT Number	NCT06117683
Lead Sponsor	Rhode Island Hospital
Conditions	Airway Management, Respiration, Artificial
Enrollment	310 participants
Start Date	2023-12-20
Primary Completion	2025-06-30 (estimated)
Study Completion	2025-07 (estimated)
Updated on ClinicalTrials.gov	2025-07-11