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.
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedJanuary 24, 2022
January 1, 2022
6 months
November 4, 2021
January 21, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Complications related to double-lumen tube intubation
1 day
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Mallampati score 3 and 4
- History of tracheostomy, tracheal deviation, or distortion
- Emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
Keçiören, Ankara, 06000, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Alagoz, Assoc Prof
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 4, 2021
First Posted
November 24, 2021
Study Start
June 1, 2021
Primary Completion
November 30, 2021
Study Completion
December 30, 2021
Last Updated
January 24, 2022
Record last verified: 2022-01