NCT07275801

Respiratory Monitoring in Supraglottic Airway Anesthesia

Not yet recruiting Last updated 10 December 2025

What this trial tests

trial testing Standard Airmod Respiratory Monitoring in Anesthesia, Intravenous in 60 participants. Not yet recruiting.

Timeline

2 January 2026

Primary endpoint
31 July 2026

31 August 2026

Quick facts

Lead sponsor	National Taiwan University Hospital
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	60
Start date	2 January 2026
Primary completion	31 July 2026
Estimated completion	31 August 2026

Drugs / interventions tested

• Standard Airmod Respiratory Monitoring

Conditions studied

• Anesthesia, Intravenous — all drugs for Anesthesia, Intravenous →
• Spontaneous Breathing — all drugs for Spontaneous Breathing →

Sponsor

National Taiwan University Hospital

Who can join

Adults 18 to 70, any sex, with Anesthesia, Intravenous or Spontaneous Breathing. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This prospective observational study evaluates the feasibility and clinical utility of AI-enhanced continuous respiratory sound monitoring during intravenous anesthesia with supraglottic airway placement. With the increasing volume of surgical procedures requiring anesthesia, continuous respiratory monitoring has become essential. While standard monitors track anesthetic depth, end-tidal CO₂, oxygen saturation, and respiratory rate, real-time respiratory sound analysis offers additional clinical value. This study aims to verify whether continuous respiratory sound monitoring using the Airmod electronic stethoscope can detect respiratory depression and airway obstruction before hypoxemia develops, thereby improving the safety of supraglottic airway anesthesia. The protocol involves collecting 60 patients undergoing elective breast surgery with supraglottic airway anesthesia (inclusion criteria: age ≥18 years, BMI \<35; exclusion criteria: emergency cases, anticipated difficult airways, age \<18, BMI \>35). During surgery, an electronic stethoscope patch provides continuous respiratory sound recording, converted to spectral data and analyzed by artificial intelligence, while standard anesthetic monitoring includes blood pressure, heart rate, bispectral index (BIS), SpO₂, and EtCO₂. Researchers document specific intraoperative events including airway positioning, oxygen flow adjustments, ventilation parameter changes, oxygen desaturation episodes, and abnormalities detected via auscultation. Anesthetic records, surgical notes, and recovery records are compiled in Excel format integrated with electronic medical records, with statistical analysis performed using SigmaPlot software. This research builds upon the Airmod electronic stethoscope approved for marketing in February 2025, aiming to establish device-specific respiratory monitoring protocols while enhancing patient safety during non-intubated anesthesia procedures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.