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临床试验/NCT07275801
NCT07275801尚未招募不适用

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

National Taiwan University Hospital0 个研究点目标入组 60 人开始时间: 2026年1月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Time interval from respiratory event to oxygen desaturation

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Emergency surgical cases
  • with known or predicted difficult airways

结局指标

主要结局

Time interval from respiratory event to oxygen desaturation

时间窗: Intraoperative period (from sedation induction to the end of procedure)

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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