跳至主要内容
临床试验/NCT07280546
NCT07280546招募中不适用

Analysis of Breath Sounds During Surgery

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月3日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Accuracy of electronic breath sound monitoring during surgery

研究概览

简要总结

This study aims to analyze breath sounds during surgery by using electronic stethoscope sensors attached to patients under general anesthesia. The study will evaluate whether breath sound monitoring can provide useful information for respiratory management, assist anesthesiologists in early detection of abnormal breathing events, and support safer perioperative care. A total of 30 adult patients undergoing elective surgery under general anesthesia will be enrolled.

详细描述

Continuous breath sound monitoring has the potential to provide anesthesiologists with real-time physiological information that is not captured by standard perioperative monitors. During general anesthesia, subtle changes in airflow or airway patency may precede clinically apparent respiratory compromise. Traditional auscultation is intermittent, subjective, and dependent on the operator's experience. Recent advances in electronic stethoscope technology enable continuous, high-fidelity acquisition of breath sound signals, allowing quantitative analysis and automated detection of abnormal respiratory patterns.

In this prospective observational study, adult patients undergoing elective surgery under general anesthesia will have electronic stethoscope sensors placed on the anterior chest wall prior to induction. Breath sound signals will be continuously recorded throughout anesthesia and surgery. Signal acquisition parameters (sampling rate, filtering, and sensor placement) will be standardized across participants. All breath sound recordings will be synchronized with standard intraoperative monitoring data, including respiratory rate, tidal volume, capnography, pulse oximetry, and hemodynamic parameters. The synchronized dataset will allow temporal correlation between acoustic features and clinically documented respiratory events.

Collected signals will undergo post-processing to extract quantitative acoustic features such as amplitude, frequency distribution, airflow-related patterns, and event-associated spectral changes. Episodes suggestive of abnormal respiration-such as diminished breath sounds, irregular airflow patterns, obstruction-like signatures, or apnea-like silent periods-will be identified and compared with clinical observations recorded by anesthesia providers. The study will also evaluate the feasibility of integrating continuous breath sound information into perioperative workflows, including the practicality of sensor placement, stability of recordings during surgical manipulation, and compatibility with existing monitoring systems.

The overall goal of the study is to generate foundational evidence on the technical feasibility and clinical relevance of continuous breath sound monitoring under general anesthesia. Findings from this study may support future development of automated respiratory event detection tools and may contribute to safer perioperative respiratory management.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 20 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective surgery under general anesthesia
  • Provided written informed consent

排除标准

  • History of respiratory disease (e.g., COPD, severe asthma)
  • Previous airway surgery or anatomical abnormalities that interfere with breath sound assessment
  • Refusal to participate or inability to comply with study procedures

结局指标

主要结局

Accuracy of electronic breath sound monitoring during surgery

时间窗: During surgery (from induction of anesthesia until emergence)

Assessment will be based on the proportion of intraoperative respiratory events correctly identified by the electronic breath sound monitoring system compared with standard clinical assessment.

次要结局

  • Incidence of respiratory events detected by the device(Intraoperative period.)
  • Correlation between electronic breath sound monitoring and clinical observation(Intraoperative period.)
  • User feasibility and device performance(Immediately after surgery (postoperative evaluation).)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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