Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone

Launched by RHODE ISLAND HOSPITAL · Feb 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Adult Sotair® to see if it can improve breathing support during surgery compared to traditional manual ventilation. The trial will involve two groups of participants, where one group will use the Sotair® device attached to a manual breathing bag, while the other group will use manual ventilation alone. Researchers want to find out if using the Sotair® device provides better and safer breathing support for patients undergoing non-emergency surgeries with general anesthesia.

To be eligible for this trial, participants should be adults aged 18 to 80 who are scheduled for non-emergency surgery and are in good health (classified as Physical Status 1 or 2 by the American Society of Anesthesiologists). Those with certain health issues, particularly serious respiratory problems or facial conditions, will not be able to participate. If you join the study, you'll have the chance to help researchers understand how this new device can enhance patient care during surgery, while being monitored closely to ensure your safety throughout the process.

Gender

ALL

Eligibility 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