Clinical trial NCT06731517: Comparison of Ultrasound, CT, and Classical Methods for Selecting Sizes and Placement of Left-Sided Double-Lumen Tubes
Official title: Comparison of Ultrasound and CT-Based Anatomical Measurements with Classical Methods for Predicting Size and Optimal Placement Depth of Left-Sided Double-Lumen Endobronchial Tubes in Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Neoplasms
Keywords: double lumen tube
size
depth
malposition
ultrasonography
computed tomography
fiber optic bronchoscopy
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: "A total of 150 patients aged 18-80 years, requiring lung isolation in thoracic surgery, with an American Society of Anesthesiologists (ASA) risk score of 1-2-3, who were literate and able to provide informed consent, were included in the study."

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.

Eligibility criteria: 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

Primary outcomes:
measure: malposition
timeFrame: 10 minutes
measure: Appropriateness of the Selected DLT Size
timeFrame: 10 minutes
measure: Appropriateness of Double-Lumen Tube Placement
timeFrame: 10 minutes
Secondary outcomes:
measure: Subglottic resistance
timeFrame: 10 minutes
measure: Petechiae
timeFrame: 10 minutes
measure: Hoarseness
timeFrame: 24 hours
measure: Throat Pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: SUMRU ŞEKERCİ, PROF
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang X, Wang DX, Wei JQ, Liu H, Hu SP. Recent advances in double-lumen tube malposition in thoracic surgery: A bibliometric analysis and narrative literature review. Front Med (Lausanne). 2022 Dec 14;9:1071254. doi: 10.3389/fmed.2022.1071254. eCollection 2022.
citation: Chang TR, Yuan MK, Pan SF, Chuang CC, So EC. Double-Lumen Endotracheal Tube-Predicting Insertion Depth and Tube Size Based on Patient's Chest X-ray Image Data and 4 Other Body Parameters. Diagnostics (Basel). 2022 Dec 14;12(12):3162. doi: 10.3390/diagnostics12123162.
citation: Woo JH, Cho S, Kim YJ, Kim DY, Choi Y, Lee JW. Depth of double-lumen endobronchial tube: a comparison between real practice and clinical recommendations using height-based formulae. Anesth Pain Med (Seoul). 2023 Jan;18(1):37-45. doi: 10.17085/apm.22214. Epub 2023 Jan 10.
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citation: Brodsky JB, Macario A, Mark JB. Tracheal diameter predicts double-lumen tube size: a method for selecting left double-lumen tubes. Anesth Analg. 1996 Apr;82(4):861-4. doi: 10.1097/00000539-199604000-00032. No abstract available.
citation: Eldawlatly AA. Double lumen tube: Size and insertion depth. Saudi J Anaesth. 2021 Jul-Sep;15(3):280-282. doi: 10.4103/sja.sja_192_21. Epub 2021 Jun 19.
citation: Liu Z, Zhao L, Jia Q, Yang X, Liang SJ, He W. Chest Computed Tomography Image for Accurately Predicting the Optimal Insertion Depth of Left-Sided Double-Lumen Tube. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):855-859. doi: 10.1053/j.jvca.2017.09.025. Epub 2017 Sep 20.
citation: Zhang C, Qin X, Zhou W, He S, Liu A, Zhang Y, Dai Z, Yin J. Prediction of Left Double-Lumen Tube Size by Measurement of Cricoid Cartilage Transverse Diameter by Ultrasound and CT Multi-Planar Reconstruction. Front Med (Lausanne). 2021 Jun 16;8:657612. doi: 10.3389/fmed.2021.657612. eCollection 2021.