Double-Lumen TubeNCT05133401
Can Imaging Techniques Contribute to the Proper Insertion of Double-lumen Tubes?
An observational study of Double-Lumen Tube and Ultrasonography, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In thoracic surgery, one-lung ventilation using a double-lumen tube (DLT) is often performed to protect dependent lung and provide comfortable surgical conditions. However, serious complications and adverse events can be encountered during DLT placement. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Double-Lumen Tube, Ultrasonography, Computed Tomography
- What is being tested?
- Ultrasound-guided tracheal width measurement
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 30 Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 100 patients with a body mass index between18-35 kg/m2 in the ASA I-II-III risk group, aged 18-80, who will undergo elective thoracic surgery, require intubation with a double-lumen tube will be included in the study.
Who may be able to join
- Patients who will undergo elective thoracotomy or video-assisted thoracic surgery with general anesthesia with DLT intubation
- BMI 18 - 35 kg/m2
- Age 18 - 80 years old
Who cannot join
- Mallampati score 3 and 4
- History of tracheostomy, tracheal deviation, or distortion
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
Keçiören, Ankara, 06000
About this study
Official title: The Role of Imaging Techniques in Predicting Double-Lumen Tube Size and Positioning. Prospective Observational Study.
In thoracic surgery, one-lung ventilation using a double-lumen tube (DLT) is often performed to protect dependent lung and provide comfortable surgical conditions. However, serious complications and adverse events can be encountered during DLT placement. One of the most important steps to avoid these drawbacks is to choose the appropriate size of DLT. The width of the trachea can be measured by using different imaging methods such as computed tomography (CT) and ultrasonography (US) to predict the appropriate DLT size. CT can also contribute to the proper placement of DLT by giving us the length of the trachea and main bronchi. In this study, we hypothesized that the size of the DLT can be determined more accurately by measuring the trachea diameter by using US and CT before DLT intubation. At the same time, we aimed to determine whether the evaluation of tracheobronchial anatomy with CT would contribute to the placement of DLT at a more appropriate level.
- Conditions
- Double-Lumen Tube, Ultrasonography, Computed Tomography
- Being tested
- Ultrasound-guided tracheal width measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided tracheal width measurementDevice
Ultrasound measurements will be made with a 5-10 MegaHertz linear probe positioned in the horizontal plane at the midline of the anterior neck. After identifying the vocal cords as paired hyperechoic linear structures, the probe was moved caudally to visualize the cricoid arch. The transverse air column diameter was measured at the lower border of the cricoid cartilage.
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of the trachea diameter with ultrasound determines the size of the double-lumen tube to be used.
After measuring the diameter of the trachea with ultrasound, the doctor will determine the double-lumen tube to be used according to the ultrasound measurement. Another experienced anesthesiologist, unaware of this result, will insert the double-lumen tube that he has determined with the conventional method.
Measured: 1 hour
The measurement of the trachea diameter by computerized tomography determines the size of the double-lumen tube is used.
After measuring the diameter of the trachea with computerized tomography, the doctor will determine the double-lumen tube to be used according to the computerized tomography measurement. Another experienced anesthesiologist, unaware of this result, will insert the double-lumen tube that he has determined with the conventional method.
Measured: 1 hour
The measurement of the tracheal and main bronchi length and main bronchi diameter by computerized tomography in determining the size of the double-lumen tube and proper positioning of the double-lumen tube.
The correlation of predicted and used DLT size. In addition, the correlation between DLT malposition rate and trachea and main bronchi length and main bronchi diameter measured by imaging methods.
Measured: 1 hour
Secondary outcomes (1)
Complications related to double-lumen tube intubation
Evaluation of trauma, bleeding, sore throat and hoarseness in the airways due to double-lumen tube intubation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Jun 2021
- Primary completion30 Nov 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double-Lumen TubeStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Alagoz, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Investigators
- Ali Alagoz, Assoc Prof, Principal investigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133401
- Sponsor's protocol ID
- 2012-KAEK-15/2231
- Status last verified
- Jan 2022
- First submitted
- 4 Nov 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Imaging Techniques in Predicting Double-Lumen Tube Size and Positioning. Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05133401
- Acronym / sponsor ID
- 2012-KAEK-15/2231
- Conditions
- Double-Lumen Tube, Ultrasonography, Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 24 Nov 2021 (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.
In thoracic surgery, one-lung ventilation using a double-lumen tube (DLT) is often performed to protect dependent lung and provide comfortable surgical conditions. However, serious complications and adverse events can be encountered during DLT placement. One of the most important steps to avoid these drawbacks is to choose the appropriate size of DLT. The width of the trachea can be measured by using different imaging methods such as computed tomography (CT) and ultrasonography (US) to predict the appropriate DLT size. CT can also contribute to the proper placement of DLT by giving us the length of the trachea and main bronchi. In this study, we hypothesized that the size of the DLT can be determined more accurately by measuring the trachea diameter by using US and CT before DLT intubation. At the same time, we aimed to determine whether the evaluation of tracheobronchial anatomy with CT would contribute to the placement of DLT at a more appropriate level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 100 patients with a body mass index between18-35 kg/m2 in the ASA I-II-III risk group, aged 18-80, who will undergo elective thoracic surgery, require intubation with a double-lumen tube will be included in the study.
Key inclusion criteria (3 listed)
- Patients who will undergo elective thoracotomy or video-assisted thoracic surgery with general anesthesia with DLT intubation
- BMI 18 - 35 kg/m2
- Age 18 - 80 years old
Key exclusion criteria (3 listed)
- Mallampati score 3 and 4
- History of tracheostomy, tracheal deviation, or distortion
- Emergency surgery
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 |
|---|---|---|
| Ultrasound-guided tracheal width measurementUltrasound measurements will be made with a 5-10 MegaHertz linear probe positioned in the horizontal plane at the midline of the anterior neck. After identifying the vocal cords as paired hyperechoic linear structures, the probe was moved caudally to visualize the cricoid arch. The transverse air column diameter was measured at the lower border of the cricoid cartilage. | Device | – |
Primary outcome
The measurement of the trachea diameter with ultrasound determines the size of the double-lumen tube to be used.
Time frame: 1 hour
After measuring the diameter of the trachea with ultrasound, the doctor will determine the double-lumen tube to be used according to the ultrasound measurement. Another experienced anesthesiologist, unaware of this result, will insert the double-lumen tube that he has determined with the conventional method.
The measurement of the trachea diameter by computerized tomography determines the size of the double-lumen tube is used.
Time frame: 1 hour
After measuring the diameter of the trachea with computerized tomography, the doctor will determine the double-lumen tube to be used according to the computerized tomography measurement. Another experienced anesthesiologist, unaware of this result, will insert the double-lumen tube that he has determined with the conventional method.
The measurement of the tracheal and main bronchi length and main bronchi diameter by computerized tomography in determining the size of the double-lumen tube and proper positioning of the double-lumen tube.
Time frame: 1 hour
The correlation of predicted and used DLT size. In addition, the correlation between DLT malposition rate and trachea and main bronchi length and main bronchi diameter measured by imaging methods.
1 secondary outcome
Complications related to double-lumen tube intubation
Time frame: 1 day
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 24 Jan 2022.
Related trials for Double-Lumen Tube
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Not yet recruiting
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
Not yet recruiting
Video-guided Versus Conventional Right-sided Double-lumen Tube Placement for Thoracoscopic Surgery
Right-sided Double-lumen Tube Positioning, Lung Isolation During Thoracoscopic Surgery
Recruiting
A Randomized Controlled Trial of 3D Airway Reconstruction for Precise Double-Lumen Bronchial Intubation
Pulmonary Nodules
Recruiting
Video-guided Versus Conventional Right-sided Double-Lumen Tubes for One-Lung Ventilation in Thoracoscopic Surgery
Thoracoscopic Surgery, Double Lumen Tube Intubation
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.
Ali Alagoz, Assoc Prof principal investigator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
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 Double-Lumen Tube and Ultrasonography, run by Atatürk Chest Diseases and Chest Surgery Training and Research 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 3 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 24 Jan 2022. 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?
The measurement of the trachea diameter with ultrasound determines the size of the double-lumen tube to be used. (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 24 Jan 2022.