Analysis of Breath Sound During Thoracic Surgery

NCT05250635 | Unknown

• 1 other identifier: 2021-11-006BC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery

Keywords

double lumen endobronchial tube; stethoscope; fiberscope; electronic stethoscope

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.)

Study Arms (1)

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

Interventions

electronic stethoscope DEVICE

It includes main machine and auscultation patch, which can stick on patient's body to collect and amplify breath sound.

Patients underwent thoracic surgery

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

patients undergo thoracic surgery and general anesthesia using DLET

You may qualify if:

• patients undergo thoracic surgery and general anesthesia using DLET

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Chien-Kun Ting

  Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

Central Study Contacts

Che Chen

CONTACT

+886910665621; freddychentw@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 22, 2022
• Study Start: February 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)