Analysis of Breath Sounds During Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-03

Study Completion Date

2026-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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General Anesthesia Intraoperative Monitoring Respiratory Sounds

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation Group

Patients undergoing elective surgery under general anesthesia with endotracheal intubation. Electronic stethoscope patches will be placed to record and analyze intraoperative breath sounds. Target enrollment: 30 participants.

Electronic stethoscope monitoring

Intervention Type 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.

Interventions

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Electronic 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hui-Hsuan Ke, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

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Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hui-Hsuan Ke, MD

Role: CONTACT

[email protected]

-886-939-196-809

References

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Manecke GR Jr, Dilger JP, Kutner LJ, Poppers PJ. Auscultation revisited: the waveform and spectral characteristics of breath sounds during general anesthesia. Int J Clin Monit Comput. 1997 Nov;14(4):231-40. doi: 10.1007/BF03356568.

Reference Type BACKGROUND

PMID: 9451573 (View on PubMed)

Mansy HA, O'Connor CJ, Balk RA, Sandler RH. Breath sound changes associated with malpositioned endotracheal tubes. Med Biol Eng Comput. 2005 Mar;43(2):206-11. doi: 10.1007/BF02345956.

Reference Type BACKGROUND

PMID: 15865129 (View on PubMed)

Wei TJ, Hsiung PY, Liu JH, Lin TC, Kuo FT, Wu CY. Use of Electronic Auscultation in Full Personal Protective Equipment to Detect Ventilation Status in Selective Lung Ventilation: A Randomized Controlled Trial. Front Med (Lausanne). 2022 Feb 21;9:851395. doi: 10.3389/fmed.2022.851395. eCollection 2022.

Reference Type BACKGROUND

PMID: 35265648 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: Full Protocol and SAP (Version 1.0)_1206

View Document

Study Documents

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Document Type: Study Protocol

The study protocol describing the methodology of electronic auscultation of breath sounds during anesthesia will be available. De-identified respiratory sound data and related analysis scripts may be shared upon reasonable request to the principal investigator.

View Document