NCT06731517

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 2, 2024

Last Update Submit

December 9, 2024

Conditions

Keywords

double lumen tubesizedepthmalpositionultrasonographycomputed tomographyfiber optic bronchoscopy

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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.

    10 minutes

Secondary Outcomes (4)

  • Subglottic resistance

    10 minutes

  • Petechiae

    10 minutes

  • Hoarseness

    24 hours

  • Throat Pain

    24 hours

Study Arms (3)

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.

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.

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.

Procedure: intubation

Interventions

intubationPROCEDURE

Double-Lumen Tube Intubation

Classical groupComputed TomographyUltrasonography group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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."

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, ÇANKAYA, 06530, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 36590949BACKGROUND
  • 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.

    PMID: 36553170BACKGROUND
  • 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.

    PMID: 36746900BACKGROUND
  • 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.

    PMID: 30286004BACKGROUND
  • 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.

    PMID: 8615510BACKGROUND
  • 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.

    PMID: 34764835BACKGROUND
  • 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.

    PMID: 29221981BACKGROUND
  • 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.

    PMID: 34222278BACKGROUND

MeSH Terms

Conditions

Thoracic Neoplasms

Interventions

Intubation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • SUMRU ŞEKERCİ, PROF

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 12, 2024

Study Start

October 20, 2023

Primary Completion

March 20, 2024

Study Completion

March 25, 2024

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations