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Clinical Trials/NCT06731517
NCT06731517
Completed
Not Applicable

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

Ankara City Hospital Bilkent1 site in 1 country150 target enrollmentOctober 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thoracic Neoplasms
Sponsor
Ankara City Hospital Bilkent
Enrollment
150
Locations
1
Primary Endpoint
malposition
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2023
End Date
March 25, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Subglottic resistance(10 minutes)
  • Petechiae(10 minutes)
  • Hoarseness(24 hours)
  • Throat Pain(24 hours)

Study Sites (1)

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