Respiratory Monitoring in Supraglottic Airway Anesthesia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled to undergo elective breast surgery

with anesthetic plan of intravenous anesthesia with supraglottic airway and spontaneous breathing

Disqualifiers

Emergency surgical cases

with known or predicted difficult airways

Trial population

Adult patients scheduled for elective breast surgery under total intravenous anesthesia with supraglottic airway at National Taiwan University Hospital, Taipei, Taiwan

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard Airmod Respiratory Monitoring

    Device

    An AI-powered respiratory monitoring device that continuously analyzes auscultated tracheal sounds to estimate respiratory rate and alert on apnea. The device's acoustic sensor is attached to the pretracheal region of a subject using a double-sided sticker, and the attachment is secured with 3M tape.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: respiratory monitoring group1 intervention

Trial outcomes

Primary outcomes

1

Time interval from respiratory event to oxygen desaturation

Time interval (in seconds) between respiratory events (apnea and partial airway obstruction) indicated by Airmod and oxygen desaturation (SpO2 ≥3% decrease from baseline) detected by pulse oximetry.

Time frame
Intraoperative period (from sedation induction to the end of procedure)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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