NCT06117683 Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
| NCT ID | NCT06117683 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rhode Island Hospital |
| Condition | Airway Management |
| Study Type | INTERVENTIONAL |
| Enrollment | 310 participants |
| Start Date | 2023-12-20 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 310 participants in total. It began in 2023-12-20 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Mark Kendall, MD
PRINCIPAL INVESTIGATOR
Rhode Island Hospital
Frequently Asked Questions
Who can join the NCT06117683 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Airway Management. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06117683 currently recruiting?
Yes, NCT06117683 is actively recruiting participants. Contact the research team at stephanie.farias@lifespan.org for enrollment information.
Where is the NCT06117683 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT06117683 clinical trial?
NCT06117683 is sponsored by Rhode Island Hospital. The principal investigator is Mark Kendall, MD at Rhode Island Hospital. The trial plans to enroll 310 participants.