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NCT Number: NCT07465510

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

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.

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Key information

Conditions

Thoracic Surgery With One-lung Ventilation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Intraoperative (immediately after DLT 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.

Secondary outcomes

  1. Agreement between methods

    Time frame: Intraoperative

    Agreement between lung ultrasound, auscultation, and fiberoptic bronchoscopy in confirming DLT position will be evaluated using Cohen's kappa coefficient.

  2. Diagnostic accuracy of auscultation for confirmation of double-lumen tube placement

    Time frame: Intraoperative

    Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of auscultation for confirming correct double-lumen tube placement compared with fiberoptic bronchoscopy.

  3. Time required to confirm correct double-lumen tube placement

    Time frame: Immediately after tube placement

    Time required to confirm correct double-lumen endobronchial tube position using lung ultrasound, auscultation and fiberoptic bronchoskopy.

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

    Time frame: ıntraoperative (immediately after DLT placement)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cansu KATKAY, M.D.

CONTACT

[email protected]

+905423847269

Sponsors and collaborators

Lead sponsor

Izmir City Hospital

Other Gov

Registry information

Official study title

Ultrasonographic Confirmation of Double-Lumen Endobronchial Tube Placement Compared With Auscultation and Fiberoptic Bronchoscopy in Thoracic Surgery: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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