Thoracic NeoplasmsNCT06731517

Comparison of Ultrasound, CT, and Classical Methods for Selecting Sizes and Placement of Left-Sided Double-Lumen Tubes

An observational study of Thoracic Neoplasms, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Investigators aimed to compare anatomical measurements obtained using ultrasound and computed tomography with classical methods to select the appropriate size of double-lumen tubes more quickly and easily and to determine the optimal depth of placement. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Thoracic Neoplasms
What is being tested?: intubation
Type of treatment: Surgery or procedure
How many people: 150 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 20 Oct 2023to 25 Mar 2024
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
Healthy volunteers accepted
Adult, Older adult

Study population: "A total of 150 patients aged 18-80 years, requiring lung isolation in thoracic surgery, with an American Society of Anesthesiologists (ASA) risk score of 1-2-3, who were literate and able to provide informed consent, were included in the study."

Who may be able to join

Requiring lung isolation in thoracic surgery,
American Society of Anesthesiologists (ASA) risk score of 1-2-3,
Patients who are literate and able to provide informed consent

Who cannot join

Patients with an ASA score of 4 or higher,
Criteria for difficult intubation,
Difficulty in mouth opening, small jaw deformities,
Abnormal cricoid cartilage appearance,
A history of laryngeal or neck surgery,
Preoperative throat pain and hoarseness,
Tumors and deformities in the main airway

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ankara Bilkent City Hospital
Ankara, ÇANKAYA, 06530

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Ultrasound and CT-Based Anatomical Measurements with Classical Methods for Predicting Size and Optimal Placement Depth of Left-Sided Double-Lumen Endobronchial Tubes in Thoracic Surgery

Read the detailed description

In modern thoracic anesthesia, one-lung ventilation (OLV) is essential for managing surgeries, and double-lumen tubes (DLTs) have been a key advancement. DLTs allow separate lung ventilation, facilitating lung deflation and preventing material transfer to the healthy lung. However, improper DLT placement can compromise these functions, emphasizing the importance of correct sizing and positioning.

Choosing the right DLT size depends heavily on patient-specific factors. Undersized DLTs can cause airway injuries, increased resistance, and displacement, while oversized DLTs are linked to postoperative issues like sore throat and difficult intubation. Despite this, no universal criterion exists for DLT size selection. Traditional methods rely on height and gender, but weak correlations with airway size often lead to improper choices, especially in shorter individuals.

Imaging techniques like chest X-rays, Computed Tomography (CT), and ultrasonography (USG) offer a more precise approach to airway measurements for DLT selection. USG is especially advantageous due to its accessibility, speed, and ease of use in operating rooms and emergencies. To improve the accuracy and ease of DLT size selection and placement, investigators aimed to compare anatomical measurements from USG and CT with traditional methods.

Conditions: Thoracic Neoplasms
Being tested: intubation
Keywords: double lumen tube, size, depth, malposition, ultrasonography, computed tomography, fiber optic bronchoscopy
Medical subject headings: Thoracic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intubationProcedure or surgery
Double-Lumen Tube Intubation

Study groups in NCT06731517
Study group	Role	What they receive
Classical group		In the classical group, Double Lumen Tube selection was based on gender and height. For males, a 41 F tube was chosen if height >170 cm, and a 39 F tube if height ≤170 cm. For females, a 37 F tube was used if height >160 cm, and a 35 F tube if height ≤160 cm. The depth was determined using the formula: 12 + (patient height/10). The calculated depth was marked on the DLT, and after intubation, the mark was positioned at the level of the upper teeth. Receives: Procedure: intubation
Ultrasonography group		In the Ultrasonography (USG) group, Double Lumen Tube selection was based on the transverse cricoid cartilage diameter measured preoperatively using ultrasound. A 41 F tube was selected if the cricoid diameter was ≥18 mm, 39 F for 16-17.9 mm, 37 F for 15-15.9 mm, 35 F for 13-14.9 mm, and 32 F for <13 mm (Table 5) (5). To determine placement depth, the distance between the vocal cords and the Louis angle was measured (the Louis angle was used as a guide as it anatomically aligns with the carina). The position of the vocal cords was identified using USG. The measured length was marked starting from the bronchial cuff line, and this mark was positioned at the level of the vocal cords during intubation. Receives: Procedure: intubation
Computed Tomography		In the Computed Tomography (CT) group, Double Lumen Tube selection was based on CT measurements. Radiologists measured the cricoid diameter and the distance between the carina and the vocal cords. A 41 F tube was selected if the cricoid diameter was ≥18 mm, 39 F for 16-17.9 mm, 37 F for 15-15.9 mm, 35 F for 13-14.9 mm, and 32 F for <13 mm (Table 5) (5). The calculated depth was marked starting from the bronchial cuff line, and this mark was positioned at the level of the vocal cords during intubation. Receives: Procedure: intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

malposition
After intubation in all three groups;
1. The upper teeth level was checked and the cm was recorded. It was checked whether both lungs were equally ventilated with the inspection and auscultation method. First, the tube lumens were clamped on the left side; it was checked whether the right lung was ventilated, then the same procedure was repeated for the right side and noted. Then, both lungs were ventilated with 6-8 ml/kg tidal volume and the airway pressure was recorded. With the help of the clamp, the left side was clamped first, the right lung was ventilated with 4-6 ml/kg tidal volume and the airway pressure was checked. The same procedure was repeated for the other side. It was determined whether there was sufficient isolation according to the difference between the airway pressures and recorded.
Isolation criteria:
Satisfactory isolation: If the respiratory sounds are clearly heard on the opposite side when one lung is isolated and the airway pressure on the other side increa
Measured: 10 minutes
Appropriateness of the Selected DLT Size
The selected tube was evaluated to see if it was of appropriate size.
Appropriate size: If the double-lumen tube tip entered the left main bronchus and no obvious resistance was encountered and there was no airway leakage and isolation was achieved when the bronchial cuff was inflated with 1-3 ml and the tracheal cuff with 2-6 ml of air, it was accepted that the double-lumen tube was selected in an appropriate size.
Large tube: If the double-lumen tube tip could not enter the left main bronchus or was placed in the left main bronchus, but when the bronchial cuff was inflated with less than 1 ml and the tracheal cuff with less than 2 ml of air, pulmonary isolation was achieved and there was no air leakage, it was accepted that it was a large-sized double-lumen tube.
Small tube: If the bronchial cuff was inflated with more than 3 ml and the tracheal cuff with more than 6 ml of air, pulmonary isolation was achieved and there was no air leakage, it was accepted that it was a small-size
Measured: 10 minutes
Appropriateness of Double-Lumen Tube Placement
While the patient was in the supine position, the location of the tube was checked with fiber optic bronchoscopy. It was noted whether the tube was in its optimum location. If not, how many cm it should be advanced or retracted for its optimum location.
Measured: 10 minutes

Secondary outcomes (4)

Subglottic resistance
Subglottic resistance was assessed and recorded as none, mild, moderate, or severe based on the level of resistance.
Measured: 10 minutes
Petechiae
It was noted with FOB whether there were petechiae in the trachea, bronchi, or both.
Measured: 10 minutes
Hoarseness
Hoarseness was assessed as follows.
0: No hoarseness
1. Hoarseness noticed by the patient
2. Hoarseness noticed by the observer
3. Aphonia
Measured: 24 hours
Throat Pain
Throat pain was assessed and recorded 24 hours postoperatively.
Sore throat; evaluated as follows.
0: No sore throat
1. Mild pain with swallowing
2. Constant pain that increases with swallowing
3. Severe pain that prevents eating and requires analgesia
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 202325 Mar 2024

First posted12 Dec 2024
Study start20 Oct 2023
Primary completion20 Mar 2024
Study completion25 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Thoracic NeoplasmsStudies of the same condition, open and under way.
More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
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: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06731517
Sponsor's protocol ID: ANKCHBILKENT-ANES-SO-01
Status last verified: Dec 2024
First submitted: 2 Dec 2024
Last updated: 12 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhang X, Wang DX, Wei JQ, Liu H, Hu SP. Recent advances in double-lumen tube malposition in thoracic surgery: A bibliometric analysis and narrative literature review. Front Med (Lausanne). 2022 Dec 14;9:1071254. doi: 10.3389/fmed.2022.1071254. eCollection 2022.
PubMed 36590949
Chang TR, Yuan MK, Pan SF, Chuang CC, So EC. Double-Lumen Endotracheal Tube-Predicting Insertion Depth and Tube Size Based on Patient's Chest X-ray Image Data and 4 Other Body Parameters. Diagnostics (Basel). 2022 Dec 14;12(12):3162. doi: 10.3390/diagnostics12123162.
PubMed 36553170
Woo JH, Cho S, Kim YJ, Kim DY, Choi Y, Lee JW. Depth of double-lumen endobronchial tube: a comparison between real practice and clinical recommendations using height-based formulae. Anesth Pain Med (Seoul). 2023 Jan;18(1):37-45. doi: 10.17085/apm.22214. Epub 2023 Jan 10.
PubMed 36746900
Shiqing L, Wenxu Q, Yuqiang M, Youjing D. Predicting the Size of a Left Double-Lumen Tube for Asian Women Based on the Combination of the Diameters of the Cricoid Ring and Left Main Bronchus: A Randomized, Prospective, Controlled Trial. Anesth Analg. 2020 Mar;130(3):762-768. doi: 10.1213/ANE.0000000000003839.
PubMed 30286004
Brodsky JB, Macario A, Mark JB. Tracheal diameter predicts double-lumen tube size: a method for selecting left double-lumen tubes. Anesth Analg. 1996 Apr;82(4):861-4. doi: 10.1097/00000539-199604000-00032. No abstract available.
PubMed 8615510
Eldawlatly AA. Double lumen tube: Size and insertion depth. Saudi J Anaesth. 2021 Jul-Sep;15(3):280-282. doi: 10.4103/sja.sja_192_21. Epub 2021 Jun 19.
PubMed 34764835
Liu Z, Zhao L, Jia Q, Yang X, Liang SJ, He W. Chest Computed Tomography Image for Accurately Predicting the Optimal Insertion Depth of Left-Sided Double-Lumen Tube. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):855-859. doi: 10.1053/j.jvca.2017.09.025. Epub 2017 Sep 20.
PubMed 29221981
Zhang C, Qin X, Zhou W, He S, Liu A, Zhang Y, Dai Z, Yin J. Prediction of Left Double-Lumen Tube Size by Measurement of Cricoid Cartilage Transverse Diameter by Ultrasound and CT Multi-Planar Reconstruction. Front Med (Lausanne). 2021 Jun 16;8:657612. doi: 10.3389/fmed.2021.657612. eCollection 2021.
PubMed 34222278

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Ultrasound and CT-Based Anatomical Measurements with Classical Methods for Predicting Size and Optimal Placement Depth of Left-Sided Double-Lumen Endobronchial Tubes in Thoracic Surgery
ClinicalTrials.gov ID: NCT06731517
Acronym / sponsor ID: ANKCHBILKENT-ANES-SO-01
Conditions: Thoracic Neoplasms
Keywords: double lumen tube, size, depth, malposition, ultrasonography, computed tomography, fiber optic bronchoscopy
Study type: Observational
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Ankara City Hospital BilkentUniversity, hospital or other
Study start: 20 Oct 2023 (actual)
Primary completion: 20 Mar 2024 (actual)
Study completion: 25 Mar 2024 (actual)
First posted: 12 Dec 2024 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Classical group	–	Procedure: intubationIn the classical group, Double Lumen Tube selection was based on gender and height. For males, a 41 F tube was chosen if height >170 cm, and a 39 F tube if height ≤170 cm. For females, a 37 F tube was used if height >160 cm, and a 35 F tube if height ≤160 cm. The depth was determined using the formula: 12 + (patient height/10). The calculated depth was marked on the DLT, and after intubation, the mark was positioned at the level of the upper teeth.
Ultrasonography group	–	Procedure: intubationIn the Ultrasonography (USG) group, Double Lumen Tube selection was based on the transverse cricoid cartilage diameter measured preoperatively using ultrasound. A 41 F tube was selected if the cricoid diameter was ≥18 mm, 39 F for 16-17.9 mm, 37 F for 15-15.9 mm, 35 F for 13-14.9 mm, and 32 F for <13 mm (Table 5) (5). To determine placement depth, the distance between the vocal cords and the Louis angle was measured (the Louis angle was used as a guide as it anatomically aligns with the carina). The position of the vocal cords was identified using USG. The measured length was marked starting from the bronchial cuff line, and this mark was positioned at the level of the vocal cords during intubation.
Computed Tomography	–	Procedure: intubationIn the Computed Tomography (CT) group, Double Lumen Tube selection was based on CT measurements. Radiologists measured the cricoid diameter and the distance between the carina and the vocal cords. A 41 F tube was selected if the cricoid diameter was ≥18 mm, 39 F for 16-17.9 mm, 37 F for 15-15.9 mm, 35 F for 13-14.9 mm, and 32 F for <13 mm (Table 5) (5). The calculated depth was marked starting from the bronchial cuff line, and this mark was positioned at the level of the vocal cords during intubation.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: "A total of 150 patients aged 18-80 years, requiring lung isolation in thoracic surgery, with an American Society of Anesthesiologists (ASA) risk score of 1-2-3, who were literate and able to provide informed consent, were included in the study."

Key inclusion criteria (3 listed)

Requiring lung isolation in thoracic surgery,
American Society of Anesthesiologists (ASA) risk score of 1-2-3,
Patients who are literate and able to provide informed consent

Key exclusion criteria (7 listed)

Patients with an ASA score of 4 or higher,
Criteria for difficult intubation,
Difficulty in mouth opening, small jaw deformities,
Abnormal cricoid cartilage appearance,
A history of laryngeal or neck 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
intubationDouble-Lumen Tube Intubation	Procedure or surgery	Classical group, Computed Tomography, Ultrasonography group

Primary outcome

malposition
Time frame: 10 minutes
After intubation in all three groups; 1. The upper teeth level was checked and the cm was recorded. It was checked whether both lungs were equally ventilated with the inspection and auscultation method. First, the tube lumens were clamped on the left side; it was checked whether the right lung was ventilated, then the same procedure was repeated for the right side and noted. Then, both lungs were ventilated with 6-8 ml/kg tidal volume and the airway pressure was recorded. With the help of the clamp, the left side was clamped first, the right lung was ventilated with 4-6 ml/kg tidal volume and the airway pressure was checked. The same procedure was repeated for the other side. It was determined whether there was sufficient isolation according to the difference between the airway pressures and recorded. Isolation criteria: Satisfactory isolation: If the respiratory sounds are clearly heard on the opposite side when one lung is isolated and the airway pressure on the other side increa
Appropriateness of the Selected DLT Size
Time frame: 10 minutes
The selected tube was evaluated to see if it was of appropriate size. Appropriate size: If the double-lumen tube tip entered the left main bronchus and no obvious resistance was encountered and there was no airway leakage and isolation was achieved when the bronchial cuff was inflated with 1-3 ml and the tracheal cuff with 2-6 ml of air, it was accepted that the double-lumen tube was selected in an appropriate size. Large tube: If the double-lumen tube tip could not enter the left main bronchus or was placed in the left main bronchus, but when the bronchial cuff was inflated with less than 1 ml and the tracheal cuff with less than 2 ml of air, pulmonary isolation was achieved and there was no air leakage, it was accepted that it was a large-sized double-lumen tube. Small tube: If the bronchial cuff was inflated with more than 3 ml and the tracheal cuff with more than 6 ml of air, pulmonary isolation was achieved and there was no air leakage, it was accepted that it was a small-size
Appropriateness of Double-Lumen Tube Placement
Time frame: 10 minutes
While the patient was in the supine position, the location of the tube was checked with fiber optic bronchoscopy. It was noted whether the tube was in its optimum location. If not, how many cm it should be advanced or retracted for its optimum location.

4 secondary outcomes

Subglottic resistance
Time frame: 10 minutes
Petechiae
Time frame: 10 minutes
Hoarseness
Time frame: 24 hours
Throat Pain
Time frame: 24 hours

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 12 Dec 2024.
Background: PubMed 36590949Zhang X, Wang DX, Wei JQ, Liu H, Hu SP. Recent advances in double-lumen tube malposition in thoracic surgery: A bibliometric analysis and narrative literature review. Front Med (Lausanne). 2022 Dec 14;9:1071254. doi: 10.3389/fmed.2022.1071254. eCollection 2022.
Background: PubMed 36553170Chang TR, Yuan MK, Pan SF, Chuang CC, So EC. Double-Lumen Endotracheal Tube-Predicting Insertion Depth and Tube Size Based on Patient's Chest X-ray Image Data and 4 Other Body Parameters. Diagnostics (Basel). 2022 Dec 14;12(12):3162. doi: 10.3390/diagnostics12123162.
Background: PubMed 36746900Woo JH, Cho S, Kim YJ, Kim DY, Choi Y, Lee JW. Depth of double-lumen endobronchial tube: a comparison between real practice and clinical recommendations using height-based formulae. Anesth Pain Med (Seoul). 2023 Jan;18(1):37-45. doi: 10.17085/apm.22214. Epub 2023 Jan 10.
Background: PubMed 30286004Shiqing L, Wenxu Q, Yuqiang M, Youjing D. Predicting the Size of a Left Double-Lumen Tube for Asian Women Based on the Combination of the Diameters of the Cricoid Ring and Left Main Bronchus: A Randomized, Prospective, Controlled Trial. Anesth Analg. 2020 Mar;130(3):762-768. doi: 10.1213/ANE.0000000000003839.
Background: PubMed 8615510Brodsky JB, Macario A, Mark JB. Tracheal diameter predicts double-lumen tube size: a method for selecting left double-lumen tubes. Anesth Analg. 1996 Apr;82(4):861-4. doi: 10.1097/00000539-199604000-00032. No abstract available.
Background: PubMed 34764835Eldawlatly AA. Double lumen tube: Size and insertion depth. Saudi J Anaesth. 2021 Jul-Sep;15(3):280-282. doi: 10.4103/sja.sja_192_21. Epub 2021 Jun 19.
Background: PubMed 29221981Liu Z, Zhao L, Jia Q, Yang X, Liang SJ, He W. Chest Computed Tomography Image for Accurately Predicting the Optimal Insertion Depth of Left-Sided Double-Lumen Tube. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):855-859. doi: 10.1053/j.jvca.2017.09.025. Epub 2017 Sep 20.
Background: PubMed 34222278Zhang C, Qin X, Zhou W, He S, Liu A, Zhang Y, Dai Z, Yin J. Prediction of Left Double-Lumen Tube Size by Measurement of Cricoid Cartilage Transverse Diameter by Ultrasound and CT Multi-Planar Reconstruction. Front Med (Lausanne). 2021 Jun 16;8:657612. doi: 10.3389/fmed.2021.657612. eCollection 2021.
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.

SUMRU ŞEKERCİ, PROF principal investigator

Ankara City Hospital Bilkent

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 Neoplasms, run by Ankara City Hospital Bilkent 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 7 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 12 Dec 2024. 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?

malposition (time frame: 10 minutes). 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?

On the ClinicalTrials.gov record for NCT06731517, which also lists 8 linked publications.

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 Dec 2024.