Application of Digitized Respiratory Sounds for Confirmation of the Position of the Balloon of Endobronchial Blockers

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 - an Observational Study

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

Study Overview

• Status: Unknown
• Conditions: Respiratory Sounds

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Hui-Hsun Huang, MD, PhD; Phone Number: +886-927-651-602; Email: huihsunhuang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Thoracic patients scheduled for thoracic surgery and lung isolation during the surgery

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Position of the endobronchial blocker	Position of the ballon of the endobronchial blocker (cm)	1 day

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Hui-Hsun Huang, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 28, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 19, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds
• Other Study ID Numbers: 201611044RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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