Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRhode Island Hospital
About this trial
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
Qualifiers
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
Disqualifiers
ASA PS >3 (e.g., respiratory disease)
Oropharyngeal or facial pathology
Trial design
Treatments tested in this trial
- ADULT Sotair Device
Treatment groups
310 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov