Analysis of Breath Sound During Thoracic Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Surgery
• Intervention / Treatment: Device: electronic stethoscope

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Che Chen; Phone Number: +886910665621; Email: freddychentw@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Che Chen; Phone Number: +886910665621; Email: freddychentw@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients undergo thoracic surgery and general anesthesia using DLET

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients underwent thoracic surgery; 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.	Device: electronic stethoscope; It includes main machine and auscultation patch, which can stick on patient's body to collect and amplify breath sound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of DLET intubation	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.	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.)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of breath sound and airway pressure	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.	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.)

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Study Chair: Chien-Kun Ting, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: electronic stethoscope; double lumen endobronchial tube; stethoscope; fiberscope
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds
• Other Study ID Numbers: 2021-11-006BC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No