Lung Ultrasonography vs Fiberoptic Bronchoscopy for Aiding Lung Collapse in Patient Using Double Lumen Tube

Study Overview
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Brief Summary
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The study contains the result from a comparison of diagnostic outcomes about lung collapse by using lung ultrasonography as a new diagnostic test compares to fiberoptic bronchoscopy as the standard test.

Detailed Description
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The study contains the result from a comparison of diagnostic outcomes about lung collapse by using lung ultrasonography as a new diagnostic test compares to fiberoptic bronchoscopy as a standard test. Both of them detect lung collapse reported as surgical grading lung collapse by the thoracic surgeons. The protocol was performed in a randomized controlled trial whether the subject was allocated to the ultrasonography group or the fiberoptic bronchoscopy group.

Official Title
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A Randomized Controlled Study Compare Lung Ultrasonography to Fiberoptic Bronchoscopy Confirming Double Lumen Tube Positioning for Thoracic Surgery.

Conditions
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Lung Diseases, Ultrasonography, Fiberoptic Bronchoscopy, One Lung Ventilation, Thoracic Surgery, Lung Collapse

Intervention / Treatment
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* Diagnostic Test: Lung ultrasonography by experienced anaesthesiologist
* Diagnostic Test: Fiberoptic bronchoscopy for double lumen tube's position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, age ≥18 years old American Society of Anesthesiologists(ASA) physical status classification I - III Scheduled for elective thoracic surgery which requires One lung ventilation(OLV) with Left-sided double lumen tube Exclusion Criteria: Anticipated difficult intubation or with the tracheostomy tube Patient with pneumothorax, pleural effusion, emphysema or past history of pleurodesis Patient with deranges pulmonary function test (out of forced expiration volume in 1 s, total lung capacity, forced vital capacity <50% of the predicted values) The patient refuses to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Compare lung collapse of lung ultrasonography to fiberoptic bronchoscopy.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasonography<br>Patients in this group receive lung ultrasonography to detect lung collapse after insert double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering pleural cavity. | Diagnostic Test: Lung ultrasonography by experienced anaesthesiologist<br>* Use ultrasound image of lung at upper and lower lobe to detect lung collapse and compare grading of lung collapse by surgeon as gold standard<br>|
| Active Comparator: Fiberoptic bronchoscopy<br>Patients in this group receive fiberoptic bronchoscope to detect lung collapse after inserting a double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering the pleural cavity. | Diagnostic Test: Fiberoptic bronchoscopy for double lumen tube's position<br>* Use fiberoptic bronchoscope via double lumen tube to detect optimum position of double lumen tube and record grading of lung collapse by surgeon as gold standard<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy | Compare number of patients with lung collapse detected by ultrasonography and fiberoptic bronchoscopy in patient with double lumen tube by report as specificity and sensitivity of detection of lung collapse by compare to visual grading of lung collapse by surgeon | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing to Detect Lung Collapse | Time point from evaluation of lung collapse by each test to time point of grading lung collapse by gold standard( visual grading of lung collapse by surgeon) | 30 minutes | 
| Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow | Accuracy of detection of lung collapse in thoracic patient with lung ultrasonography in cardiac anaesthesiologist after training lung ultrasonography | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracic anaesthesia, lung ultrasound, Lung ultrasonography, Lung collapse, fiberoptic bronchoscopy, double lumen tube, compare, one lung ventilation, thoracic surgery