Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
Recruiting
N/A
Interventional Study
Airway Management
Respiration, Artificial
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 310 (estimated)
- Sponsor
- Rhode Island Hospital · Other
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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 Sota…
Trial Locations
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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
Contacts