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

Completed

• Conditions: Thoracic Neoplasms

• Registration Number: NCT06731517
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Study Start: 2023-10-20
• Primary Completion: 2024-03-20
• Study Completion: 2024-03-25
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
malposition	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	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	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 Outcome Measures

Name	Time	Method
Subglottic resistance	10 minutes	Subglottic resistance was assessed and recorded as none, mild, moderate, or severe based on the level of resistance.
Petechiae	10 minutes	It was noted with FOB whether there were petechiae in the trachea, bronchi, or both.
Hoarseness	24 hours	Hoarseness was assessed as follows.; 0: No hoarseness; 1. Hoarseness noticed by the patient; 2. Hoarseness noticed by the observer; 3. Aphonia
Throat Pain	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

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Çankaya, Turkey