- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465510
Ultrasound vs. Auscultation and Fiberoptic Bronchoscopy for Double-Lumen Tube Placement
Ultrasonographic Confirmation of Double-Lumen Endobronchial Tube Placement Compared With Auscultation and Fiberoptic Bronchoscopy in Thoracic Surgery: A Prospective Observational Study
One-lung ventilation is frequently required in thoracic surgery and is most commonly achieved using double-lumen endobronchial tubes (DLTs). Correct positioning of the DLT is crucial for effective lung isolation and patient safety. Fiberoptic bronchoscopy (FOB) is considered the gold standard for confirming DLT placement; however, it may not always be immediately available and requires specific expertise.
Lung ultrasonography is a rapid, noninvasive, and bedside imaging method increasingly used in anesthesiology and critical care. This prospective observational study aims to evaluate the diagnostic performance of lung ultrasound in confirming the correct position of double-lumen endobronchial tubes in patients undergoing thoracic surgery.
The results obtained from lung ultrasound will be compared with auscultation findings and fiberoptic bronchoscopy results. Fiberoptic bronchoscopy will be considered the reference standard. The sensitivity, specificity, positive predictive value, and negative predictive value of lung ultrasound and auscultation will be calculated.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Cansu Katkay, M.D.
- Phone Number: +905423847269
- Email: cansu-katkay07@hotmail.com
Study Locations
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İzmir
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Izmir, İzmir, Turkey (Türkiye), 35150
- Recruiting
- İzmir City Hospital
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Contact:
- Cansu Katkay, M.D.
- Phone Number: +905423847269
- Email: cansu-katkay07@hotmail.com
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Contact:
- Derya Arslan Yurtlu, M.D.
- Phone Number: +905058764132
- Email: darslanyurtlu@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 and 65 years
- Scheduled for elective thoracic surgery
- Planned one-lung ventilation
- Use of double-lumen endobronchial tube
- ASA physical status I-III
- Written informed consent obtained
Exclusion Criteria:
- Known airway anomalies
- Previous lung resection surgery
- Tracheostomy
- Coagulopathy
- Pleural effusion or pleural pathology that may interfere with lung ultrasound evaluation
- Chest wall deformity
- Emergency surgery
- Patients who decline participation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Thoracic surgery patients undergoing one-lung ventilation with double-lumen tube
Adult patients undergoing elective thoracic surgery requiring one-lung ventilation with a double-lumen endobronchial tube.
Tube position will be evaluated using auscultation and lung ultrasound, and confirmed by fiberoptic bronchoscopy as the reference standard.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy of lung ultrasound for confirmation of double-lumen tube placement
Time Frame: Intraoperative (immediately after DLT placement)
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Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of lung ultrasound in confirming correct double-lumen endobronchial tube placement compared with fiberoptic bronchoscopy as the reference standard.
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Intraoperative (immediately after DLT placement)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement between methods
Time Frame: Intraoperative
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Agreement between lung ultrasound, auscultation, and fiberoptic bronchoscopy in confirming DLT position will be evaluated using Cohen's kappa coefficient.
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Intraoperative
|
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Diagnostic accuracy of auscultation for confirmation of double-lumen tube placement
Time Frame: Intraoperative
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Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of auscultation for confirming correct double-lumen tube placement compared with fiberoptic bronchoscopy.
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Intraoperative
|
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Time required to confirm correct double-lumen tube placement
Time Frame: Immediately after tube placement
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Time required to confirm correct double-lumen endobronchial tube position using lung ultrasound, auscultation and fiberoptic bronchoskopy.
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Immediately after tube placement
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Effect of right- versus left-sided double-lumen endobronchial tubes on diagnostic performance
Time Frame: ıntraoperative (immediately after DLT placement)
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Comparison of the diagnostic performance of lung ultrasound and auscultation for confirming correct double-lumen endobronchial tube position in right-sided versus left-sided double-lumen tubes, using fiberoptic bronchoscopy as the reference standard.
Measures will include sensitivity, specificity, PPV, NPV, and overall accuracy within each DLT type.
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ıntraoperative (immediately after DLT placement)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
- Lung isolation in thoracic anesthesia, state of the art
- A prospective randomized controlled double-blind study comparing auscultation and lung ultrasonography in the assessment of double lumen tube position in elective thoracic surgeries involving one lung ventilation at a tertiary care cancer institute
- Lung ultrasound is non-inferior to bronchoscopy for confirmation of double-lumen endotracheal tube positioning: a randomized controlled noninferiority study
- Role of Lung Ultrasound in Confirmation of Double Lumen Endotracheal Tube Placement for Thoracic Surgeries: A Prospective Diagnostic Accuracy Study
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- İŞH- AD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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