Thoracic Surgery With One-lung VentilationNCT07465510
Ultrasound vs. Auscultation and Fiberoptic Bronchoscopy for Double-Lumen Tube Placement
An observational study of Thoracic Surgery With One-lung Ventilation, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Surgery With One-lung Ventilation
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2026to 15 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir City Hospital
Izmir, İzmir, 35150
Derya Arslan Yurtlu, M.D., +905058764132, darslanyurtlu@yahoo.com
Cansu Katkay, M.D., +905423847269, cansu-katkay07@hotmail.com
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative (immediately after DLT placement)
Secondary outcomes (4)
Agreement between methods
Agreement between lung ultrasound, auscultation, and fiberoptic bronchoscopy in confirming DLT position will be evaluated using Cohen's kappa coefficient.
Measured: Intraoperative
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.
Measured: Intraoperative
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.
Measured: Immediately after tube placement
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.
Measured: ıntraoperative (immediately after DLT placement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start25 Jan 2026
- Primary completion25 May 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Surgery With One-lung VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Derya Arslan Yurtlu, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465510
- Sponsor's protocol ID
- İŞH- AD
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Confirmation of Double-Lumen Endobronchial Tube Placement Compared With Auscultation and Fiberoptic Bronchoscopy in Thoracic Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07465510
- Acronym / sponsor ID
- İŞH- AD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 25 Jan 2026 (actual)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Known airway anomalies
- Previous lung resection surgery
- Tracheostomy
- Coagulopathy
- Pleural effusion or pleural pathology that may interfere with lung ultrasound evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Agreement between methods
Time frame: Intraoperative
Diagnostic accuracy of auscultation for confirmation of double-lumen tube placement
Time frame: Intraoperative
Time required to confirm correct double-lumen tube placement
Time frame: Immediately after tube placement
Effect of right- versus left-sided double-lumen endobronchial tubes on diagnostic performance
Time frame: ıntraoperative (immediately after DLT placement)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Lung isolation in thoracic anesthesia, state of the artLink provided by the sponsor.
- 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 instituteLink provided by the sponsor.
- Lung ultrasound is non-inferior to bronchoscopy for confirmation of double-lumen endotracheal tube positioning: a randomized controlled noninferiority studyLink provided by the sponsor.
- Role of Lung Ultrasound in Confirmation of Double Lumen Endotracheal Tube Placement for Thoracic Surgeries: A Prospective Diagnostic Accuracy StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery With One-lung Ventilation, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cansu KATKAY, M.D. (+905423847269, cansu-katkay07@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of lung ultrasound for confirmation of double-lumen tube placement (time frame: Intraoperative (immediately after DLT placement)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.