Respiratory Monitoring in Supraglottic Airway Anesthesia

NCT ID: NCT07275801

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2026-08-31

Brief Summary

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.

Conditions

Anesthesia, Intravenous; Spontaneous Breathing

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

respiratory monitoring group

Patients receiving intravenous anesthesia with supraglottic airways

Standard Airmod Respiratory Monitoring

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yajung Cheng, PhD

Role: CONTACT

chengyj@ntu.edu.tw

+886223123456

Other Identifiers

202503042DINC

Identifier Type: -

Identifier Source: org_study_id