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Completed

NCT Number: NCT05133401

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital

Keçiören, Ankara, 06000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided tracheal width measurement

Device

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.

Primary outcomes

  1. The measurement of the trachea diameter with ultrasound determines the size of the double-lumen tube to be used.

    Time frame: 1 hour

    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.

  2. The measurement of the trachea diameter by computerized tomography determines the size of the double-lumen tube is used.

    Time frame: 1 hour

    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.

  3. 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.

    Time frame: 1 hour

    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.

Secondary outcomes

  1. Complications related to double-lumen tube intubation

    Time frame: 1 day

    Evaluation of trauma, bleeding, sore throat and hoarseness in the airways due to double-lumen tube intubation.

Sponsors and collaborators

Lead sponsor

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 24, 2021
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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