Analysis of Breath Sounds During Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorTaipei Veterans General Hospital, Taiwan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 20 years
American Society of Anesthesiologists (ASA) physical status I-III
Scheduled for elective surgery under general anesthesia
Provided written informed consent
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Electronic stethoscope monitoring
Other interventionApplication 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Observation Group1 intervention
Trial outcomes
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.
Time frame
During surgery (from induction of anesthesia until emergence)Secondary outcomes
1
Incidence of respiratory events detected by the device
Number of intraoperative respiratory events (e.g., hypoventilation, airway obstruction, disconnection) identified by the monitoring system.
Time frame
Intraoperative period.2
Correlation between electronic breath sound monitoring and clinical observation
Correlation (r-value) between device output and anesthesiologist-documented respiratory findings.
Time frame
Intraoperative period.3
User feasibility and device performance
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.)
Time frame
Immediately after surgery (postoperative evaluation).Sponsors and contacts
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Source ClinicalTrials.gov