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NCT Number: NCT07280546

Analysis of Breath Sounds During Surgery

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Electronic stethoscope monitoring

Other

Application of electronic stethoscope patches on the patient's chest during surgery to record breath sounds for subsequent analysis. No therapeutic intervention is given; this is a monitoring/observational tool.

Primary outcomes

  1. Accuracy of electronic breath sound monitoring during surgery

    Time frame: 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.

Secondary outcomes

  1. Incidence of respiratory events detected by the device

    Time frame: Intraoperative period.

    Number of intraoperative respiratory events (e.g., hypoventilation, airway obstruction, disconnection) identified by the monitoring system.

  2. Correlation between electronic breath sound monitoring and clinical observation

    Time frame: Intraoperative period.

    Correlation (r-value) between device output and anesthesiologist-documented respiratory findings.

  3. User feasibility and device performance

    Time frame: Immediately after surgery (postoperative evaluation).

    Feasibility will be assessed by reporting the proportion of cases in which continuous breath sound monitoring was successfully completed without interruption, including documentation of signal quality issues and workflow interference if present. (No rating scale will be used.)

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Hsuan Ke, MD

CONTACT

[email protected]

-886-939-196-809

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Acronym: BREATHSOUND

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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