Analysis of Breath Sound During Thoracic Surgery

Thoracic Surgery Clinical Trial

Official title:

Analysis of Breath Sound During Thoracic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250635
• Other study ID #: 2021-11-006BC
• Status: Recruiting
• Start date: February 2022
• Est. completion date: February 2023

Study information

• Verified date: February 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Che Chen
• Phone: +886910665621
• Email: freddychentw[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Sounds
• Thoracic Surgery

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.)