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Analysis of Breath Sounds During Surgery

Analysis of Breath Sounds During Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07280546
Acronym
BREATHSOUND
Enrollment
30
Registered
2025-12-12
Start date
2025-09-03
Completion date
2026-09-30
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia, Intraoperative Monitoring, Respiratory Sounds

Keywords

Breath sounds, Perioperative care, Airway monitoring, Respiratory complications, Double-lumen endotracheal tube (DLT)

Brief summary

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.

Detailed description

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.

Interventions

OTHERElectronic stethoscope monitoring

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.

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of electronic breath sound monitoring during surgeryDuring 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

MeasureTime frameDescription
Incidence of respiratory events detected by the deviceIntraoperative period.Number of intraoperative respiratory events (e.g., hypoventilation, airway obstruction, disconnection) identified by the monitoring system.
Correlation between electronic breath sound monitoring and clinical observationIntraoperative period.Correlation (r-value) between device output and anesthesiologist-documented respiratory findings.
User feasibility and device performanceImmediately 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.)

Countries

Taiwan

Contacts

Primary ContactHui-Hsuan Ke, MD
kehuihsuan0221@gmail.com-886-939-196-809

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026