Can Imaging Techniques Contribute to the Proper Insertion of Double-lumen Tubes?

Ultrasonography Clinical Trial

Official title:

The Role of Imaging Techniques in Predicting Double-Lumen Tube Size and Positioning. Prospective Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05133401
• Other study ID #: 2012-KAEK-15/2231
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2022
• Source: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In thoracic surgery, one-lung ventilation using a double-lumen tube (DLT) is often performed to protect dependent lung and provide comfortable surgical conditions. However, serious complications and adverse events can be encountered during DLT placement. One of the most important steps to avoid these drawbacks is to choose the appropriate size of DLT. The width of the trachea can be measured by using different imaging methods such as computed tomography (CT) and ultrasonography (US) to predict the appropriate DLT size. CT can also contribute to the proper placement of DLT by giving us the length of the trachea and main bronchi. In this study, we hypothesized that the size of the DLT can be determined more accurately by measuring the trachea diameter by using US and CT before DLT intubation. At the same time, we aimed to determine whether the evaluation of tracheobronchial anatomy with CT would contribute to the placement of DLT at a more appropriate level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who will undergo elective thoracotomy or video-assisted thoracic surgery with general anesthesia with DLT intubation

• BMI 18 - 35 kg/m2

• Age 18 - 80 years old

Exclusion Criteria:

• Mallampati score 3 and 4

• History of tracheostomy, tracheal deviation, or distortion

• Emergency surgery

Related Conditions & MeSH terms

• Computed Tomography
• Double-Lumen Tube
• Ultrasonography

Intervention

Device:
• Ultrasound-guided tracheal width measurement
Ultrasound measurements will be made with a 5-10 MegaHertz linear probe positioned in the horizontal plane at the midline of the anterior neck. After identifying the vocal cords as paired hyperechoic linear structures, the probe was moved caudally to visualize the cricoid arch. The transverse air column diameter was measured at the lower border of the cricoid cartilage.

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital	Keçiören	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measurement of the trachea diameter with ultrasound determines the size of the double-lumen tube to be used.	After measuring the diameter of the trachea with ultrasound, the doctor will determine the double-lumen tube to be used according to the ultrasound measurement. Another experienced anesthesiologist, unaware of this result, will insert the double-lumen tube that he has determined with the conventional method.	1 hour
Primary	The measurement of the trachea diameter by computerized tomography determines the size of the double-lumen tube is used.	After measuring the diameter of the trachea with computerized tomography, the doctor will determine the double-lumen tube to be used according to the computerized tomography measurement. Another experienced anesthesiologist, unaware of this result, will insert the double-lumen tube that he has determined with the conventional method.	1 hour
Primary	The measurement of the tracheal and main bronchi length and main bronchi diameter by computerized tomography in determining the size of the double-lumen tube and proper positioning of the double-lumen tube.	The correlation of predicted and used DLT size. In addition, the correlation between DLT malposition rate and trachea and main bronchi length and main bronchi diameter measured by imaging methods.	1 hour
Secondary	Complications related to double-lumen tube intubation	Evaluation of trauma, bleeding, sore throat and hoarseness in the airways due to double-lumen tube intubation.	1 day