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Completed
NCT06117683
Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
Conditions: Airway Management, Respiration, Artificial
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 334
Sponsor: Rhode Island Hospital
Location: Rhode Island Hospital Providence Rhode Island
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06117683). StuddyBuddy aggregates publicly available trial information.