Sotair® Device for Artificial Respiration
What You Need to Know Before You Apply
What is the purpose of 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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How is the Sotair Device treatment different from other treatments for artificial respiration?
The Sotair Device for artificial respiration is unique because it is a mechanical device specifically designed to assist with breathing, unlike traditional drug-based treatments. This device may offer a novel approach by providing a physical means to support or enhance respiratory function, which is different from medications that typically target underlying causes or symptoms.12345
What data supports the effectiveness of the Sotair® Device for Artificial Respiration treatment?
The research mentions the use of positive end-expiratory pressure (PEEP) in artificial ventilation, which is a component of the Sotair Device. PEEP is considered essential for treating critically ill patients in intensive care, suggesting that the Sotair Device may be effective in providing necessary respiratory support.678910
Who Is on the Research Team?
Mark Kendall, MD
Principal Investigator
Rhode Island Hospital
Are You a Good Fit for This Trial?
This trial is for adults in good or fair health (ASA physical status 1 and 2) who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital. They must not have a high risk of difficult mask ventilation, severe respiratory diseases, or any facial pathologies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo ventilation using either the Sotair® device or mechanical ventilation for 3 minutes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ADULT Sotair Device
ADULT Sotair Device is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rhode Island Hospital
Lead Sponsor