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

December 9, 2024 updated by: Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

150

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

    • Çankaya
      • Ankara, Çankaya, Turkey, 06530
        • Ankara Bilkent City Hospital

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

Yes

Sampling Method

Probability 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."

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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
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.
Double-Lumen Tube 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.
Double-Lumen Tube 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.
Double-Lumen Tube Intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

10 minutes
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

10 minutes
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.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subglottic resistance
Time Frame: 10 minutes
Subglottic resistance was assessed and recorded as none, mild, moderate, or severe based on the level of resistance.
10 minutes
Petechiae
Time Frame: 10 minutes
It was noted with FOB whether there were petechiae in the trachea, bronchi, or both.
10 minutes
Hoarseness
Time Frame: 24 hours

Hoarseness was assessed as follows.

0: No hoarseness

  1. Hoarseness noticed by the patient
  2. Hoarseness noticed by the observer
  3. Aphonia
24 hours
Throat Pain
Time Frame: 24 hours

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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: SUMRU ŞEKERCİ, PROF, Ankara Bilkent City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 20, 2023

Primary Completion (Actual)

March 20, 2024

Study Completion (Actual)

March 25, 2024

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Estimated)

December 12, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANKCHBILKENT-ANES-SO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Subscribe