Comparing a new device for manual ventilation to traditional mechanical ventilation
Non-inferiority Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation in Patients Undergoing Non-emergent Surgery With General Anesthesia
This study tests if a new device for manual ventilation during surgery is just as safe and effective as traditional mechanical ventilation for adult patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Rhode Island Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06117683 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Adult Sotair® device, designed to enhance manual ventilation during general anesthesia, compared to standard mechanical ventilation. It employs a pre-post study design, where participants will be assessed before and after using the device to determine its non-inferiority in maintaining safe airway pressures. The device features a flow limiting valve to prevent excessive airway pressure, aiming to improve patient safety during ventilation. The study will involve adult patients scheduled for non-emergency surgeries at Rhode Island Hospital.
Who should consider this trial
Good fit: Ideal candidates are adult patients scheduled for non-emergency surgery with ASA physical status 1 or 2.
Not a fit: Patients with ASA physical status greater than 3 or those with oropharyngeal or facial pathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could improve manual ventilation techniques, enhancing patient safety during anesthesia.
How similar studies have performed: While the approach is innovative, similar studies have not been widely reported, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Providence, Rhode Island
- Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Mark Kendall, MD — Rhode Island Hospital
- Study coordinator: Stephanie Farias
- Email: stephanie.farias@lifespan.org
- Phone: 401-444-5172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.