Analysis of Breath Sounds During Surgery

NCT07280546 | Recruiting

• 1 other identifier: 2022-09-002AC
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia; Intraoperative Monitoring; Respiratory Sounds

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Accuracy of electronic breath sound monitoring during surgery

  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.

  During surgery (from induction of anesthesia until emergence)

Secondary Outcomes (3)

• 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).

Study Arms (1)

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.

Other: Electronic stethoscope monitoring

Interventions

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.

Observation Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult surgical patients (aged 20 years or older) scheduled for elective surgery under general anesthesia at Taipei Veterans General Hospital, Taiwan. Eligible patients are ASA I-III and willing to provide informed consent. Patients with significant respiratory disease or airway abnormalities will be excluded.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Related Publications (3)

• 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.

  PMID: 9451573 BACKGROUND

• 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.

  PMID: 15865129 BACKGROUND

• 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.

  PMID: 35265648 BACKGROUND

Related Links

• Institutional Review Board of Taipei Veterans General Hospital
• Frontiers in Medicine - Electronic Auscultation Trial

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hui-Hsuan Ke, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Hsuan Ke, MD

CONTACT

-886-939-196-809; kehuihsuan0221@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: December 12, 2025
• Study Start: September 3, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available starting 6 months after study completion and for up to 5 years.
• Access Criteria: Qualified researchers who provide a methodologically sound research proposal and obtain approval from an independent ethics committee/IRB may request access to de-identified individual participant data (IPD). Requests should be directed to the Institutional Review Board (IRB) of Taipei Veterans General Hospital, Taiwan. Data will be shared through secure platforms to ensure confidentiality and compliance with ethical regulations.

Locations

TW (1)