Analysis of Breath Sound During Thoracic Surgery

• Conditions: Thoracic Surgery
• Interventions: Device: electronic stethoscope

• Registration Number: NCT05250635
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

In modern thoracic surgery, double-lumen endobronchial tube (DLET) is the first choice for intubation. One lung ventilation can be perfectly performed by DLET, with the benefit of maintaining adequate gas exchange and establishing great surgical field. Traditionally, we use stethoscope and fiberscope for DLET site evaluation. However, there are some concerns over traditional methods. Stethoscope evaluation can be subjective from person to person; fiberscope, on the other hand, can cause additional bronchial injury as it is an invasive procedure. We hope to utilize patches, also known as electronic stethoscope, which provide non-invasive and visualized spectrum information, to assist anesthesiologists evaluate DLET insertion site more precisely in patients undergo thoracic surgery.

Detailed Description

This is an observational study. We use electronic stethoscope, which stick on patient's anterior chest, to record breath sound after intubation. The soundtrack will then be transformed to visualized waveform, enabling us to analyze and compare with actual result confirmed by fiberscope.

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-02
• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-21
• Last Update Submitted: 2022-02-21
• Study First Posted: 2022-02-22
• Last Update Posted: 2022-02-22
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients undergo thoracic surgery and general anesthesia using DLET

Exclusion Criteria

• patients have no will to participate
• vulnerable groups, including physically disabled and mental diseased patients
• patients with abnormal breath sound, pulmonary disease or history of cardiothoracic surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients underwent thoracic surgery	electronic stethoscope	Patients underwent thoracic surgery and general anesthesia with usage of DLET are included. Those patients with abnormal breath sound, pulmonary disease or history of cardiothoracic surgery are excluded.

Primary Outcome Measures

Name	Time	Method
Accuracy of DLET intubation	Intraoperative (Start record the first breath sound after intubation when supine. After changing patient's position to lateral decubitus, the second breath sound is recorded. The electronic stethoscope is retrieved before the operation starts.)	By using electronic stethoscope to record breath sound, we can analyze visualized waveform and spectrum to predict probable site and depth of DLET. Then we use fiberscope for actual result. By comparing records of electronic stethoscope and fiberscope, we hope to find correlation between these two methods of evaluating appropriate intubation of DLET.

Secondary Outcome Measures

Name	Time	Method
Correlation of breath sound and airway pressure	Intraoperative (Start record the first breath sound after intubation when supine. After changing patient's position to lateral decubitus, the second breath sound is recorded. The electronic stethoscope is retrieved before the operation starts.)	During collection of breath sound, we also record airway pressure showed on ventilator at the same time. Theoretically, elevated airway pressure can be seen if airway obstruction or inappropriate intubation is happening. We hope to find correlation between airway pressure and breath sound collected by electronic stethoscope, for possible earlier detection, diagnosis and treatment.

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan