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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03061695
Other study ID # 201611044RINA
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 1, 2017
Last updated February 19, 2017
Start date February 28, 2017
Est. completion date December 31, 2017

Study information

Verified date January 2017
Source National Taiwan University Hospital
Contact Hui-Hsun Huang, MD, PhD
Phone +886-927-651-602
Email huihsunhuang@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observation study is to evaluate the application of the spectral analysis and characteristic parameters of digitized respiratory sounds in the confirmation of the position of the balloon of endobronchial blockers


Description:

This is an observational study. We will recruit 30 patients who are scheduled for thoracic surgery under general anesthesia with tracheal intubation and need endobronchial blocker for unilateral lung ventilation during the operation. The standard procedures for confirming the position of the balloon of the endobronchial blocker, including the stethoscopic inspection and the fiberoptic examination, will be performed as routine practice. But in our study, besides the above routine practice, a microphone will be connected to the distal end of the stethoscope (the microphone will not contact directly with the patients) during the checking procedure to record the breathing sound into a digital computer as electronic files. These breathing sound files will be analyzed in a later time with spectral transformation and the characteristics are extracted. These digital signal processing results will be compared with the results of fibroptic exmination and the stethoscopic auscultation in the correct rate of diagnosing the position of the endobronchial balloon. The aim of this study is to examine the usefulness of the spectral parameters of the digitalized breathing sound in confirming the position of the endobronchial blocker balloon.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Thoracic disease patients who are scheduled for thoracic surgery and lung isolation requiring endobronchial blocker placement during the surgery

- Adult patients (no younger than 20 years old)

Exclusion Criteria:

- Patients with significant thoracic diseases which result in abnormal respiratory sounds

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Position of the endobronchial blocker Position of the ballon of the endobronchial blocker (cm) 1 day
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