Clinical trial NCT05133401: Can Imaging Techniques Contribute to the Proper Insertion of Double-lumen Tubes?
Official title: The Role of Imaging Techniques in Predicting Double-Lumen Tube Size and Positioning. Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Double-Lumen Tube
Ultrasonography
Computed Tomography
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The measurement of the trachea diameter with ultrasound determines the size of the double-lumen tube to be used.
timeFrame: 1 hour
measure: The measurement of the trachea diameter by computerized tomography determines the size of the double-lumen tube is used.
timeFrame: 1 hour
measure: 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.
timeFrame: 1 hour
Secondary outcomes:
measure: Complications related to double-lumen tube intubation
timeFrame: 1 day
Other outcomes:
Locations:
city: Keçiören
country: Turkey
facility: University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
state: Ankara
Study officials:
affiliation: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
name: Ali Alagoz, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: