Ultrasound vs. Auscultation and Fiberoptic Bronchoscopy for Double-Lumen Tube Placement

NCT07465510 | Recruiting

• 1 other identifier: İŞH- AD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracic Surgery With One-lung Ventilation

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of lung ultrasound for confirmation of double-lumen tube placement

  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.

  Intraoperative (immediately after DLT placement)

Secondary Outcomes (4)

• Agreement between methods

  Intraoperative

• Diagnostic accuracy of auscultation for confirmation of double-lumen tube placement

  Intraoperative

• Time required to confirm correct double-lumen tube placement

  Immediately after tube placement

• Effect of right- versus left-sided double-lumen endobronchial tubes on diagnostic performance

  ıntraoperative (immediately after DLT placement)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18-65 years undergoing elective thoracic surgery requiring one-lung ventilation with a double-lumen endobronchial tube at Izmir City Hospital will be included in this study. Patients will be recruited consecutively after providing written informed consent. The position of the double-lumen tube will be evaluated using auscultation and lung ultrasonography and confirmed by fiberoptic bronchoscopy as part of routine clinical practice.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir City Hospital: lead

Study Sites (1)

Izmir City Hospital

Izmir, İzmir, 35150, Turkey (Türkiye)

RECRUITING

Related 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

Central Study Contacts

Cansu KATKAY, M.D.

CONTACT

+905423847269; cansu-katkay07@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: January 25, 2026
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)