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

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

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.

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Computed Tomography; Double-Lumen Tube
• Intervention / Treatment: Device: Ultrasound-guided tracheal width measurement

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Keçiören, Ankara, Turkey, 06000
      • University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 100 patients with a body mass index between18-35 kg/m2 in the ASA I-II-III risk group, aged 18-80, who will undergo elective thoracic surgery, require intubation with a double-lumen tube will be included in the study.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
• Investigators: Principal Investigator: Ali Alagoz, Assoc Prof, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2021
• Primary Completion (ACTUAL): November 30, 2021
• Study Completion (ACTUAL): December 30, 2021

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (ACTUAL): November 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2012-KAEK-15/2231

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No