Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation

Launched by RHODE ISLAND HOSPITAL · Oct 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Adult Sotair®, which is designed to help with manual breathing support during surgery. The goal is to see if this device works just as well as traditional mechanical ventilation, which is a machine that helps patients breathe when they are under anesthesia. The trial will involve patients who are having non-emergency surgeries at Rhode Island Hospital and are generally healthy.

To participate, patients need to be between the ages of 18 and 75 and must be in good physical health (classified as American Society of Anesthesiologists status 1 or 2). Those with serious respiratory issues or certain facial conditions will not be eligible. Participants in the study can expect to use the Sotair® device during their procedure and will help researchers understand if it is a safe and effective alternative to mechanical ventilation. Overall, this trial aims to improve how we manage breathing support for patients during surgery.

Gender

ALL

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