Status:
RECRUITING
Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
Lead Sponsor:
Rhode Island Hospital
Conditions:
Airway Management
Respiration, Artificial
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 crea...
Detailed Description
Poor manual ventilation technique is a well-documented problem which occurs irrespective of a provider's qualifications or experience. A disposable safety device, Adult Sotair®, was created to improve...
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
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT06117683
Start Date
December 20 2023
End Date
July 1 2025
Last Update
July 11 2025
Active Locations (1)
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1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903