ClinicalTrials.gg
RecruitingNCT07465510Updated Mar 12, 2026

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

An observational study in Thoracic Surgery With One-lung Ventilation, sponsored by Izmir City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Izmir City Hospital · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Thoracic Surgery With One-lung Ventilation
03

In context

Lead sponsor

Izmir City Hospital is the lead sponsor of 25 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18 and 65 years
  • Scheduled for elective thoracic surgery
  • Planned one-lung ventilation
  • Use of double-lumen endobronchial tube
  • I-III
  • Written obtained

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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 researchers measure

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.

    Time frame: Intraoperative (immediately after DLT placement)

Secondary outcomes

  1. Agreement between methods

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

    Time frame: Intraoperative

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

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

    Time frame: Intraoperative

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

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

    Time frame: Immediately after tube placement

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

    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.

    Time frame: ıntraoperative (immediately after DLT placement)

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Study locations

1 of 1 sites recruiting
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References and documents

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2026 (actual). Primary completion is estimated for May 2026, 4 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2026
First posted
Mar 12, 2026
StartActual
Jan 25, 2026
Primary completionEst.
May 25, 2026
CompletionEst.
Jun 15, 2026
Last update
Mar 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07465510
Lead sponsor
Izmir City Hospital
Responsible party
Derya Arslan Yurtlu (Professor Doctor, Izmir City Hospital) — Principal investigator
First posted
Mar 12, 2026
Start date
Jan 25, 2026
Primary completion
May 25, 2026 (estimated)
Completion
Jun 15, 2026 (estimated)
Last update
Mar 12, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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