Double-lumen TubeNCT07191002
The Role of Existing Formulas in the Double-lumen Tube in Thoracic Surgery Anesthesia
An observational study of Double-lumen Tube and One-lung Ventilation (OLV), run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In most clinical scenarios, left DLT is preferred for one-lung ventilation because of its anatomical ease of placement; these tubes allow separate ventilation of both lungs. If the DLT is not placed in the proper size and depth, it may result in repeated intubation attempts, airway and dental trauma, failed lung… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Double-lumen Tube, One-lung Ventilation (OLV), Thoracic Anesthesia
- What is being tested?
- placement depth of the double lumen tube
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 1 Feb 2026
- 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: The study will begin prospectively after obtaining approval from the ethics committee and will be completed once the target number of patients has been reached. The study population will consist of patients aged 18-80 years who will undergo thoracic surgery at the operating rooms of the Department of Anesthesiology and Reanimation, Ankara Atatürk Sanatorium Training and Research Hospital.
Who may be able to join
- Patients older than 18 and younger than 80 years
- Patients who will undergo surgery under general anesthesia and be intubated with a left DLT
- Patients with an American Society of Anesthesiologists (ASA) score of I-II-III
- Patients with a body mass index (BMI) between 18-40 kg/m²
- Patients who provide informed consent
Who cannot join
- Patients requiring right DLT placement
- Patients with ASA score IV and above
- Patients intubated with a single-lumen tube
- Patients in whom lung isolation will be achieved with a method other than DLT
- Emergency cases
- Patients younger than 18 or older than 80 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Ataturk Sanatorium Training and Research Hospital, Ankara, 06280
Ankara
About this study
Official title: The Role of Existing Formulas and Airway Measurements in Determining the Appropriate Placement Depth of the Double-lumen Tube in Thoracic Surgery Anesthesia: a Prospective Observational Study
In most clinical scenarios, left DLT is preferred for one-lung ventilation because of its anatomical ease of placement; these tubes allow separate ventilation of both lungs. If the DLT is not placed in the proper size and depth, it may result in repeated intubation attempts, airway and dental trauma, failed lung isolation, tube dislodgement, and various unwanted events such as hypoxemia.
The first and most common method for correct placement of a DLT is the conventional technique, blindly advanced into the left main bronchus, and then confirmed with fiberoptic bronchoscopy (FOB). In this method, the depth at which the tube should be left before performing FOB is left to the clinician's experience. Generally, the DLT is advanced in the trachea until a slight resistance is felt. This may lead to excessive advancement of the DLT into the left main bronchus or premature resistance due to the tube tip touching the carina, causing the clinician to stop before entering the left main bronchus. Therefore, just as selecting the correct size of the DLT is crucial, correctly estimating the appropriate depth is also of great importance. For this reason, different formulas have been proposed in the literature, and new formulas are still being investigated.
Read more
The patient's gender and height are determinant in selecting the appropriate size of the DLT. However, studies in the literature indicate that the accuracy of these formulas may be limited in Asian populations. Therefore, it is important to evaluate the applicability of these formulas in different populations and, if necessary, develop new formulas. In the Turkish population as well, verifying the accuracy of these formulas for determining the proper size and depth of DLT-and if needed, developing new recommendations and formulas-holds clinical importance.
In this study, conducted at Ankara Atatürk Sanatorium Training and Research Hospital, the aim is to evaluate the accuracy of six different formulas available in the literature for predicting DLT depth in patients undergoing thoracic surgery. Additionally, the correlations between DLT depth and demographic parameters as well as external airway measurements (mouth opening, sternomental distance, thyromental distance, distance between the mentum and manubrio-sternal angle, distance between tragus and manubrio-sternal angle, distance between sternal angle and xiphoid process) will be analyzed. Furthermore, challenges during DLT application, malposition rates and types, and complications will be assessed.
The primary objective of this study is to evaluate, in patients undergoing thoracic surgery at Ankara Atatürk Sanatorium Training and Research Hospital, how accurate and applicable six different formulas defined in the literature are for predicting the placement depth of the DLT. If the existing formulas are insufficient, the aim is to develop a new formula.
Read the detailed description
Hypothesis H0 (Null Hypothesis): The formulas defined in the literature accurately predict the placement depth of the left double-lumen tube (DLT) in the Turkish population; therefore, no additional measurement methods are required.
H1 (Alternative Hypothesis): The formulas defined in the literature do not accurately predict the placement depth of the left double-lumen tube (DLT) in the Turkish population; therefore, DLT placement depth can be predicted more accurately using external anatomical parameters and population-specific measurement methods, and additional measurement methods are required.
Study Design The study has been designed as a single-center, prospective observational study.
Study Setting/ Location The study will be conducted at Ankara Atatürk Sanatorium Training and Research Hospital, in the Department of Anesthesiology and Reanimation, Thoracic Surgery operating room.
Study Population The study will begin prospectively after obtaining approval from the ethics committee and will be completed once the target number of patients has been reached. The study population will consist of patients aged 18-80 years who will undergo thoracic surgery at the operating rooms of the Department of Anesthesiology and Reanimation, Ankara Atatürk Sanatorium Training and Research Hospital.
Inclusion Criteria:
- Patients older than 18 and younger than 80 years
- Patients who will undergo surgery under general anesthesia and be intubated with a left DLT
- Patients with an American Society of Anesthesiologists (ASA) score of I-II-III
- Patients with a body mass index (BMI) between 18-40 kg/m²
- Patients who provide informed consent
Exclusion Criteria:
- Patients requiring right DLT placement
- Patients with ASA score IV and above
- Patients intubated with a single-lumen tube
- Patients in whom lung isolation will be achieved with a method other than DLT
- Emergency cases
- Patients younger than 18 or older than 80 years Primary and Secondary Outcome
Primary Outcome:
The primary outcome of the study is the consistency between the DLT depths calculated using six different formulas defined in the literature and the actual placement depth confirmed by fiberoptic bronchoscopy (FOB).
Secondary Outcomes:
- The relationship between external anatomical measurements (mouth opening, sternomental distance, thyromental distance, distance between mentum and manubrio-sternal angle, distance between tragus and manubrio-sternal angle, distance between sternal angle and xiphoid process) and DLT depth.
- The correlation between patients' demographic characteristics (height, weight, sex, body mass index) and DLT placement depth.
- The frequency of technical difficulties encountered during DLT placement (e.g., difficulty in intubation, intubation time, need for maneuvers, requirement for repositioning).
- Distribution of malposition rates and types (early, late; proximal and distal positioning, etc.).
- Frequency and types of complications (e.g., hypoxemia, airway trauma, dental injury, tube dislodgement, etc.).
- If existing formulas are found to be inconsistent, development of a new formula specifically for the Turkish population.
This thesis study will be conducted in accordance with the Declaration of Helsinki and, after obtaining approval from the relevant units and the ethics committee, will be carried out at Ankara Atatürk Sanatorium Training and Research Hospital.
Patients aged 18-80 years who will undergo thoracic surgery and agree to participate in the study by signing the informed consent form will be prospectively enrolled. A total of 30 patients will be included in the study. All patients will be informed about the study process, and informed consent will be obtained.
Inclusion criteria: patients over 18 and under 80 years of age, intubated with a left DLT, American Society of Anesthesiologists (ASA) score I-II-III, body mass index (BMI) between 18-40 kg/m², and undergoing surgery under general anesthesia.
Exclusion criteria: patients requiring right DLT placement, patients with ASA IV and above, patients intubated with a single-lumen tube, patients in whom lung isolation is achieved by a method other than DLT.
During routine preoperative anesthesia evaluation, demographic data such as age, height, body weight, body mass index (BMI), sex, comorbidities, prior surgeries, ASA score, Mallampati classification, mouth opening, sternomental distance, thyromental distance, distance between mentum and manubrio-sternal angle, distance between tragus and manubrio-sternal angle, and distance between sternal angle and xiphoid process will be recorded.
No additional procedures specific to this study will be performed. After anesthesia induction, the anesthesiologist will select the appropriate DLT size and placement depth entirely at their discretion, as per routine practice, and confirm both using fiberoptic bronchoscopy (FOB). If malposition occurs, it will be corrected under FOB guidance, and the tube will be secured in the correct position. No intervention or guidance will be given to the anesthesiologist during this process.
After DLT placement, the insertion depth will be measured at the corner of the mouth. During DLT application, any difficulties encountered, malposition rates and types, complications, and perioperative or postoperative events related to DLT use (such as hoarseness, sore throat, dental injury, lip or oral trauma, cough) will be recorded. Hemodynamic parameters (systolic arterial pressure [SAP], diastolic arterial pressure [DAP], mean arterial pressure [MAP], heart rate, oxygen saturation) will be recorded at the following time points: before induction, after induction, immediately after intubation, just before extubation, and immediately after extubation.
The study is planned to be completed within 3-6 months after obtaining ethics committee approval. It will be terminated once the target study population is achieved.
- Being tested
- placement depth of the double lumen tube
- Keywords
- Double-Lumen Tube, Fiberoptic Bronchoscopy, Airway Measurements, One-Lung Ventilation, Tube Placement Depth, Thoracic Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placement depth of the double lumen tubeOther
the anesthesiologist will select the appropriate DLT size and placement depth entirely at their discretion, as per routine practice, and confirm both using fiberoptic bronchoscopy (FOB). If malposition occurs, it will be corrected under FOB guidance, and the tube will be secured in the correct position
| Study group | Role | What they receive |
|---|---|---|
| intubated with a left DLT | Patients who will undergo surgery under general anesthesia and be intubated with a left DLT Receives: Other: placement depth of the double lumen tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
consistency between the DLT depths calculated using six different formulas
The primary outcome of the study is the consistency between the DLT depths calculated using six different formulas defined in the literature and the actual placement depth confirmed by fiberoptic bronchoscopy (FOB).
Measured: during perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start15 Sep 2025
- Primary completion1 Jan 2026
- Study completion1 Feb 2026
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ramazan Baldemir, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- ELİF DURMUŞ, Principal investigator, ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191002
- Sponsor's protocol ID
- 2024-BÇEK/344
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 3 Nov 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Existing Formulas and Airway Measurements in Determining the Appropriate Placement Depth of the Double-lumen Tube in Thoracic Surgery Anesthesia: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07191002
- Acronym / sponsor ID
- 2024-BÇEK/344
- Keywords
- Double-Lumen Tube, Fiberoptic Bronchoscopy, Airway Measurements, One-Lung Ventilation, Tube Placement Depth, Thoracic Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 24 Sep 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.
In most clinical scenarios, left DLT is preferred for one-lung ventilation because of its anatomical ease of placement; these tubes allow separate ventilation of both lungs. If the DLT is not placed in the proper size and depth, it may result in repeated intubation attempts, airway and dental trauma, failed lung isolation, tube dislodgement, and various unwanted events such as hypoxemia.
The first and most common method for correct placement of a DLT is the conventional technique, blindly advanced into the left main bronchus, and then confirmed with fiberoptic bronchoscopy (FOB). In this method, the depth at which the tube should be left before performing FOB is left to the clinician's experience. Generally, the DLT is advanced in the trachea until a slight resistance is felt. This may lead to excessive advancement of the DLT into the left main bronchus or premature resistance due to the tube tip touching the carina, causing the clinician to stop before entering the left main bronchus. Therefore, just as selecting the correct size of the DLT is crucial, correctly estimating the appropriate depth is also of great importance. For this reason, different formulas have been proposed in the literature, and new formulas are still being investigated.
The patient's gender and height are determinant in selecting the appropriate size of the DLT. However, studies in the literature indicate that the accuracy of these formulas may be limited in Asian populations. Therefore, it is important to evaluate the applicability of these formulas in different populations and, if necessary, develop new formulas. In the Turkish population as well, verifying the accuracy of these formulas for determining the proper size and depth of DLT-and if needed, developing new recommendations and formulas-holds clinical importance.
In this study, conducted at Ankara Atatürk Sanatorium Training and Research Hospital, the aim is to evaluate the accuracy of six different formulas available in the literature for predicting DLT depth in patients undergoing thoracic surgery. Additionally, the correlations between DLT depth and demographic parameters as well as external airway measurements (mouth opening, sternomental distance, thyromental distance, distance between the mentum and manubrio-sternal angle, distance between tragus and manubrio-sternal angle, distance between sternal angle and xiphoid process) will be analyzed. Furthermore, challenges during DLT application, malposition rates and types, and complications will be assessed.
The primary objective of this study is to evaluate, in patients undergoing thoracic surgery at Ankara Atatürk Sanatorium Training and Research Hospital, how accurate and applicable six different formulas defined in the literature are for predicting the placement depth of the DLT. If the existing formulas are insufficient, the aim is to develop a new formula.
Detailed description
Hypothesis H0 (Null Hypothesis): The formulas defined in the literature accurately predict the placement depth of the left double-lumen tube (DLT) in the Turkish population; therefore, no additional measurement methods are required.
H1 (Alternative Hypothesis): The formulas defined in the literature do not accurately predict the placement depth of the left double-lumen tube (DLT) in the Turkish population; therefore, DLT placement depth can be predicted more accurately using external anatomical parameters and population-specific measurement methods, and additional measurement methods are required.
Study Design The study has been designed as a single-center, prospective observational study.
Study Setting/ Location The study will be conducted at Ankara Atatürk Sanatorium Training and Research Hospital, in the Department of Anesthesiology and Reanimation, Thoracic Surgery operating room.
Study Population The study will begin prospectively after obtaining approval from the ethics committee and will be completed once the target number of patients has been reached. The study population will consist of patients aged 18-80 years who will undergo thoracic surgery at the operating rooms of the Department of Anesthesiology and Reanimation, Ankara Atatürk Sanatorium Training and Research Hospital.
Inclusion Criteria:
- Patients older than 18 and younger than 80 years
- Patients who will undergo surgery under general anesthesia and be intubated with a left DLT
- Patients with an American Society of Anesthesiologists (ASA) score of I-II-III
- Patients with a body mass index (BMI) between 18-40 kg/m²
- Patients who provide informed consent
Exclusion Criteria:
- Patients requiring right DLT placement
- Patients with ASA score IV and above
- Patients intubated with a single-lumen tube
- Patients in whom lung isolation will be achieved with a method other than DLT
- Emergency cases
- Patients younger than 18 or older than 80 years Primary and Secondary Outcome
Primary Outcome:
The primary outcome of the study is the consistency between the DLT depths calculated using six different formulas defined in the literature and the actual placement depth confirmed by fiberoptic bronchoscopy (FOB).
Secondary Outcomes:
- The relationship between external anatomical measurements (mouth opening, sternomental distance, thyromental distance, distance between mentum and manubrio-sternal angle, distance between tragus and manubrio-sternal angle, distance between sternal angle and xiphoid process) and DLT depth.
- The correlation between patients' demographic characteristics (height, weight, sex, body mass index) and DLT placement depth.
- The frequency of technical difficulties encountered during DLT placement (e.g., difficulty in intubation, intubation time, need for maneuvers, requirement for repositioning).
- Distribution of malposition rates and types (early, late; proximal and distal positioning, etc.).
- Frequency and types of complications (e.g., hypoxemia, airway trauma, dental injury, tube dislodgement, etc.).
- If existing formulas are found to be inconsistent, development of a new formula specifically for the Turkish population.
This thesis study will be conducted in accordance with the Declaration of Helsinki and, after obtaining approval from the relevant units and the ethics committee, will be carried out at Ankara Atatürk Sanatorium Training and Research Hospital.
Patients aged 18-80 years who will undergo thoracic surgery and agree to participate in the study by signing the informed consent form will be prospectively enrolled. A total of 30 patients will be included in the study. All patients will be informed about the study process, and informed consent will be obtained.
Inclusion criteria: patients over 18 and under 80 years of age, intubated with a left DLT, American Society of Anesthesiologists (ASA) score I-II-III, body mass index (BMI) between 18-40 kg/m², and undergoing surgery under general anesthesia.
Exclusion criteria: patients requiring right DLT placement, patients with ASA IV and above, patients intubated with a single-lumen tube, patients in whom lung isolation is achieved by a method other than DLT.
During routine preoperative anesthesia evaluation, demographic data such as age, height, body weight, body mass index (BMI), sex, comorbidities, prior surgeries, ASA score, Mallampati classification, mouth opening, sternomental distance, thyromental distance, distance between mentum and manubrio-sternal angle, distance between tragus and manubrio-sternal angle, and distance between sternal angle and xiphoid process will be recorded.
No additional procedures specific to this study will be performed. After anesthesia induction, the anesthesiologist will select the appropriate DLT size and placement depth entirely at their discretion, as per routine practice, and confirm both using fiberoptic bronchoscopy (FOB). If malposition occurs, it will be corrected under FOB guidance, and the tube will be secured in the correct position. No intervention or guidance will be given to the anesthesiologist during this process.
After DLT placement, the insertion depth will be measured at the corner of the mouth. During DLT application, any difficulties encountered, malposition rates and types, complications, and perioperative or postoperative events related to DLT use (such as hoarseness, sore throat, dental injury, lip or oral trauma, cough) will be recorded. Hemodynamic parameters (systolic arterial pressure [SAP], diastolic arterial pressure [DAP], mean arterial pressure [MAP], heart rate, oxygen saturation) will be recorded at the following time points: before induction, after induction, immediately after intubation, just before extubation, and immediately after extubation.
The study is planned to be completed within 3-6 months after obtaining ethics committee approval. It will be terminated once the target study population is achieved.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intubated with a left DLT | – | Other: placement depth of the double lumen tubePatients who will undergo surgery under general anesthesia and be intubated with a left DLT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will begin prospectively after obtaining approval from the ethics committee and will be completed once the target number of patients has been reached. The study population will consist of patients aged 18-80 years who will undergo thoracic surgery at the operating rooms of the Department of Anesthesiology and Reanimation, Ankara Atatürk Sanatorium Training and Research Hospital.
Key inclusion criteria (5 listed)
- Patients older than 18 and younger than 80 years
- Patients who will undergo surgery under general anesthesia and be intubated with a left DLT
- Patients with an American Society of Anesthesiologists (ASA) score of I-II-III
- Patients with a body mass index (BMI) between 18-40 kg/m²
- Patients who provide informed consent
Key exclusion criteria (6 listed)
- Patients requiring right DLT placement
- Patients with ASA score IV and above
- Patients intubated with a single-lumen tube
- Patients in whom lung isolation will be achieved with a method other than DLT
- Emergency cases
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 |
|---|---|---|
| placement depth of the double lumen tubethe anesthesiologist will select the appropriate DLT size and placement depth entirely at their discretion, as per routine practice, and confirm both using fiberoptic bronchoscopy (FOB). If malposition occurs, it will be corrected under FOB guidance, and the tube will be secured in the correct position | Other | intubated with a left DLT |
Primary outcome
consistency between the DLT depths calculated using six different formulas
Time frame: during perioperative
The primary outcome of the study is the consistency between the DLT depths calculated using six different formulas defined in the literature and the actual placement depth confirmed by fiberoptic bronchoscopy (FOB).
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 3 Nov 2026.
- 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. This study is not recruiting at the moment.
ELİF DURMUŞ principal investigator
ANKARA ATATURK SANATORİUM TRAİNİNG 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 One-lung Ventilation (OLV), run by Ankara Ataturk Sanatorium 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 5 inclusion and 6 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 3 Nov 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?
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?
consistency between the DLT depths calculated using six different formulas (time frame: during perioperative). 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 3 Nov 2026.