Lung CancerNCT07107893
Comparison of Double Lumen Tube Location Verification Techniques in Single Lung Ventilation
An observational study of Lung Cancer and Lung Diseases, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare auscultation, fiberoptic bronchoscopy (FOB) and video double lumen tube (VDLT) double lumen tube (DLT) location confirmation techniques in terms of intraoperative tube location confirmation time, number of tube dislocations, correction time of dislocations, FOB usage rates, lung… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Lung Cancer, Lung Diseases
- What is being tested?
- double lumen tube with video
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jan 2025to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 84 years
- All sexes
- Adult, Older adult
Study population: Ninety-three patients who would undergo thoracic surgery with single-lung ventilation at the Health Sciences University Kayseri City Training and Research Hospital Anesthesiology and Reanimation Clinic were evaluated for suitability.
Who may be able to join
- Patients who will undergo TAV and be placed in the lateral position.
- Patients with ASA scores of I-III.
- Patients aged 18-84.
Who cannot join
- Patients undergoing emergency surgery
- Patients with American Society of Anesthesiology (ASA) IV and above
- Patients with anticipated difficult intubation
- Patients requiring intubation with a right thoracic duct (CLT)
- Patients with more than three intubation attempts
- Patients who refuse to participate in the study
Show all 12Show fewer
- Patients who will undergo TAV but will not be placed in the lateral position (sympathectomy)
- Patients with uncontrolled metabolic disease
- Mentally retarded patients
- Patients under 18 or over 84
- Patients with tracheal or airway abnormalities
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri Şehir Hastanesi
Kayseri, Kocasinan, 38080
About this study
Official title: Comparison of Double Lumen Tube Location Verification Techniques in Single Lung Ventilation: Auscultation, Fiberoptic Bronchoscopy, and Video Double Lumen Tube
The aim of this study was to compare auscultation, fiberoptic bronchoscopy (FOB) and video double lumen tube (VDLT) double lumen tube (DLT) location confirmation techniques in terms of intraoperative tube location confirmation time, number of tube dislocations, correction time of dislocations, FOB usage rates, lung deflation quality, postoperative sore throat, presence of hoarseness and cost in thoracic surgery patients undergoing one lung ventilation (OLV).
Read the detailed description
The single-center, prospective and observational study included 93 patients aged 18-84 years, American Society of Anesthesiology (ASA) I-III, who were to undergo one-lung ventilation in the lateral decubitus position by thoracic surgery under elective conditions. Patients were randomized into Group I: Group with confirmed tube location by auscultation, Group II: Group with confirmed tube location by FOB and Group III: The group in which double lumen tube with video was used. Demographic data of the patients, intubation times, tube site confirmation times, number of type dislocation, dislocation correction time, number and duration of FOB use, quality of lung deflation, presence of postoperative sore throat and hoarseness were recorded. The three groups were compared in terms of cost.
- Conditions
- Lung Cancer, Lung Diseases
- Being tested
- double lumen tube with video
- Keywords
- Double lumen tube with video, Single lung ventilation
- Medical subject headings
- Lung Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double lumen tube with videoDevice
Also called fiberoptic bronchoscope
Methods used to confirm tube placement in one-lung ventilation: auscultation, fiberoptic bronchoscopy, and video to evaluate double-lumen tube use
| Study group | Role | What they receive |
|---|---|---|
| grup I | Group with confirmed tube location by auscultation | |
| Grup II | Group with confirmed tube location by fiberoptic bronchoscope | |
| Grup III | The group in which double lumen tube with video was used Receives: Device: double lumen tube with video |
What is being measured
The primary outcome is the main question the study is designed to answer.
verification of tube location
The primary endpoint is the identification of a method that allows the quickest confirmation of double-lumen tube location after intubation and possible intraoperative location changes.
Measured: during surgery
Secondary outcomes (1)
evaluation of complications
The secondary endpoint was to determine the superiority of three methods over each other in preventing complications that may occur due to inadequate tube location confirmation.
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start16 Jan 2025
- Primary completion15 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Arzu Fırat Durbilmez, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107893
- Sponsor's protocol ID
- 2024-KEAK-01
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Double Lumen Tube Location Verification Techniques in Single Lung Ventilation: Auscultation, Fiberoptic Bronchoscopy, and Video Double Lumen Tube
- ClinicalTrials.gov ID
- NCT07107893
- Acronym / sponsor ID
- 2024-KEAK-01
- Conditions
- Lung Cancer, Lung Diseases
- Keywords
- Double lumen tube with video, Single lung ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 6 Aug 2025 (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.
The aim of this study was to compare auscultation, fiberoptic bronchoscopy (FOB) and video double lumen tube (VDLT) double lumen tube (DLT) location confirmation techniques in terms of intraoperative tube location confirmation time, number of tube dislocations, correction time of dislocations, FOB usage rates, lung deflation quality, postoperative sore throat, presence of hoarseness and cost in thoracic surgery patients undergoing one lung ventilation (OLV).
Detailed description
The single-center, prospective and observational study included 93 patients aged 18-84 years, American Society of Anesthesiology (ASA) I-III, who were to undergo one-lung ventilation in the lateral decubitus position by thoracic surgery under elective conditions. Patients were randomized into Group I: Group with confirmed tube location by auscultation, Group II: Group with confirmed tube location by FOB and Group III: The group in which double lumen tube with video was used. Demographic data of the patients, intubation times, tube site confirmation times, number of type dislocation, dislocation correction time, number and duration of FOB use, quality of lung deflation, presence of postoperative sore throat and hoarseness were recorded. The three groups were compared in terms of cost.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| grup I | – | –Group with confirmed tube location by auscultation |
| Grup II | – | –Group with confirmed tube location by fiberoptic bronchoscope |
| Grup III | – | Device: double lumen tube with videoThe group in which double lumen tube with video was used |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Ninety-three patients who would undergo thoracic surgery with single-lung ventilation at the Health Sciences University Kayseri City Training and Research Hospital Anesthesiology and Reanimation Clinic were evaluated for suitability.
Key inclusion criteria (3 listed)
- Patients who will undergo TAV and be placed in the lateral position.
- Patients with ASA scores of I-III.
- Patients aged 18-84.
Key exclusion criteria (12 listed)
- Patients undergoing emergency surgery
- Patients with American Society of Anesthesiology (ASA) IV and above
- Patients with anticipated difficult intubation
- Patients requiring intubation with a right thoracic duct (CLT)
- Patients with more than three intubation attempts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| double lumen tube with videoAlso: fiberoptic bronchoscopeMethods used to confirm tube placement in one-lung ventilation: auscultation, fiberoptic bronchoscopy, and video to evaluate double-lumen tube use | Device | Grup III |
Primary outcome
verification of tube location
Time frame: during surgery
The primary endpoint is the identification of a method that allows the quickest confirmation of double-lumen tube location after intubation and possible intraoperative location changes.
1 secondary outcome
evaluation of complications
Time frame: during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer and Lung Diseases, run by Kayseri 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 6 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
verification of tube location (time frame: during surgery). 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 6 Aug 2025.