Non-inferiority Comparative Trial Between Sotair4 Device Attached to Manual Resuscitator Versus Mechanical Ventilation in Patients Undergoing Non-emergent Surgery With General Anesthesia

What this Trial Is About

Researchers are studying the use of the Adult Sotair4 device, a disposable safety device designed to improve manual ventilation during surgery. The study aims to test whether this device is not inferior to mechanical ventilation in terms of airway pressure management in adult patients undergoing non-emergency surgery with general anesthesia. The study focuses on achieving effective ventilation by controlling airflow and pressure to reduce risks such as air entering the stomach. Participants will receive two types of ventilation in sequence. First, anesthesia providers will manually ventilate using the Adult Sotair4 device attached to a bag valve mask for 3 minutes. Then, mechanical ventilation will be applied for another 3 minutes while pressure and flow are recorded. The device limits peak flow rates and airway pressure to enhance safety during manual ventilation. During the study, researchers will monitor several respiratory and cardiovascular parameters including peak airway pressure, tidal volume, airflow, respiratory rate, oxygen saturation, end tidal CO2, blood pressure, and heart rate for 3 minutes under each ventilation method. The entire process involves continuous recording of these measurements to compare the performance of the device versus mechanical ventilation. Participants will be followed during their scheduled non-emergency surgery and monitored closely throughout the ventilation periods.

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