Clinical Research Directory
Browse clinical research sites, groups, and studies.
Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
Sponsor: Rhode Island Hospital
Summary
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.
Official title: Non-inferiority Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation in Patients Undergoing Non-emergent Surgery With General Anesthesia
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2023-12-20
Completion Date
2025-07
Last Updated
2025-07-11
Healthy Volunteers
No
Conditions
Interventions
ADULT Sotair Device
Sotair® device employs a flow limiting and pressure control valve mechanism.
Locations (1)
Rhode Island Hospital
Providence, Rhode Island, United States