Comparing a new device for better manual ventilation during surgery
A Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Manual Ventilation Alone in Patients Undergoing Non-emergent Surgery with General Anesthesia: a Prospective Randomized Cross-over Clinical Trial
NA · Rhode Island Hospital · NCT06261619
This study is testing a new device that helps doctors provide better breathing support during surgery to see if it works better than the usual method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Rhode Island Hospital (other) |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06261619 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Adult Sotair® device, which is designed to enhance manual ventilation during general anesthesia. The study employs a two-group crossover randomized design to compare the performance of the Sotair® device attached to a manual resuscitator against standard manual ventilation alone. By limiting excessive airway pressure, the device aims to improve patient safety and ventilation outcomes. The trial will involve adult patients undergoing non-emergency surgery at Rhode Island Hospital.
Who should consider this trial
Good fit: Ideal candidates are adult patients scheduled for non-emergency surgery with general anesthesia and classified as American Society of Anesthesiologists Physical Status 1 or 2.
Not a fit: Patients with American Society of Anesthesiologists 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 significantly improve the safety and effectiveness of manual ventilation during surgeries.
How similar studies have performed: While the approach of using a device to enhance manual ventilation is innovative, similar studies have not been widely reported, making this a potentially novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients who are scheduled for non-emergency surgery with general anesthesia (w/artificial airway) at Rhode Island Hospital. * American Society Of Anesthesiologists Physical Status 1 and 2 Exclusion Criteria: * American Society of Anesthesiologists Physical Status \>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: Mark Kendall, MD
- Email: mark.kendall@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.
Conditions: Airway Management, Respiration, Artificial, Mechanical Ventilation, General Anesthesia, Bag Mask Ventilation, Adult Sotair Device