Respiratory Monitoring in Supraglottic Airway Anesthesia

Continuous Breath Sound Monitoring Applied to Intravenous Anesthesia and Laryngeal Mask Airway Respiratory Monitoring: A Clinical Outcome Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia, Intravenous; Spontaneous Breathing
• Intervention / Treatment: Device: Standard Airmod Respiratory Monitoring

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Yajung Cheng, PhD; Phone Number: +886223123456; Email: chengyj@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Scheduled to undergo elective breast surgery
2. with anesthetic plan of intravenous anesthesia with supraglottic airway and spontaneous breathing

Exclusion Criteria:

1. Emergency surgical cases
2. with known or predicted difficult airways

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
respiratory monitoring group; Patients receiving intravenous anesthesia with supraglottic airways	Device: Standard Airmod Respiratory Monitoring; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative period (from sedation induction to the end of procedure)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: respiration, monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Aspiration
• Other Study ID Numbers: 202503042DINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No