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Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone
Sponsor: Rhode Island Hospital
Summary
Effective respiratory ventilation is achieved by moving the right amount of air to 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 superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.
Official title: A Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Manual Ventilation Alone in Patients Undergoing Non-emergent Surgery With General Anesthesia: A Prospective Randomized Cross-over Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-05-09
Completion Date
2025-03-18
Last Updated
2026-07-21
Healthy Volunteers
No
Conditions
Interventions
Adult Sotair Device
Adult Sotair® device employs a flow limiting valve mechanism.
Locations (1)
Rhode Island Hospital
Providence, Rhode Island, United States