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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07465510
Enrollment
100
Registered
2026-03-12
Start date
2026-01-25
Completion date
2026-06-15
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Surgery With One-lung Ventilation

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.

Interventions

None listed

Sponsors

Izmir City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of lung ultrasound for confirmation of double-lumen tube placementIntraoperative (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

MeasureTime frameDescription
Agreement between methodsIntraoperativeAgreement between lung ultrasound, auscultation, and fiberoptic bronchoscopy in confirming DLT position will be evaluated using Cohen's kappa coefficient.
Diagnostic accuracy of auscultation for confirmation of double-lumen tube placementIntraoperativeSensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of auscultation for confirming correct double-lumen tube placement compared with fiberoptic bronchoscopy.
Time required to confirm correct double-lumen tube placementImmediately after tube placementTime required to confirm correct double-lumen endobronchial tube position using lung ultrasound, auscultation and fiberoptic bronchoskopy.
Effect of right- versus left-sided double-lumen endobronchial tubes on diagnostic performanceıntraoperative (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.

Countries

Turkey (Türkiye)

Contacts

CONTACTCansu KATKAY, M.D.
cansu-katkay07@hotmail.com+905423847269

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026