- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07107893
- Original Trial
Comparison of Double Lumen Tube Location Verification Techniques in Single Lung Ventilation
August 3, 2025 updated by: Arzu Fırat Durbilmez, Kayseri City Hospital
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
93
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kocasinan
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Kayseri, Kocasinan, Turkey, 38080
- Kayseri Şehir Hastanesi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- Patients who will undergo TAV and be placed in the lateral position.
- Patients with ASA scores of I-III.
- Patients aged 18-84.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Methods used to confirm tube placement in one-lung ventilation: auscultation, fiberoptic bronchoscopy, and video to evaluate double-lumen tube use
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
during surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluation of complications
Time Frame: during surgery
|
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.
|
during surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cost effectiveness
Time Frame: during surgery
|
The other endpoint is to determine the superiority of the three methods over each other in terms of reducing costs.
|
during surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 16, 2025
Primary Completion (Actual)
April 15, 2025
Study Completion (Actual)
April 30, 2025
Study Registration Dates
First Submitted
July 17, 2025
First Submitted That Met QC Criteria
August 3, 2025
First Posted (Actual)
August 6, 2025
Study Record Updates
Last Update Posted (Actual)
August 6, 2025
Last Update Submitted That Met QC Criteria
August 3, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-KEAK-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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