- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02691468
Displacement Between PVC and Silicon DLT
Comparison of Displacement Between Polyvinyl Chloride(PVC) and Silicon Double-Lumen Endobronchial Tubes(DLT) During Change of Position
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lung isolation and differential lung ventilation, resulting in collapse of operative lung and ventilation of non-operating lung (one lung ventilation; OLV) are essential for thoracic surgery in lung, esophagus and thoracic aorta.
DLT, consisted of tracheal and bronchial lumens, is commonly used to perform differential lung ventilation. The correct position of each lumen in trachea and main bronchus is essential for successful OLV. However, DLT displacement occurs commonly while patients are changed position from the supine to the lateral. The deleterious consequences of a malpositioned DLT can be substantial, even life-threatening including severe hypoxemia.
Considering displacement of DLT during position change and surgical traction, previous studies recommended endobronchial cuff of DLT should be positioned at 0.5cm below the tracheal carina when using left-sided DLT. However, it is based on the data from several research conducted by PVC DLT.
These days, Silicon DLT, different in material from PVC DLT, is also widely used in clinical practice. Silicon DLT is different in not only position of ballon but also distance of each lumen. Furthermore,there are no identified studies about the displacement of silicon DLT during patient position change in thoracic surgery.
Therefore, it is necessary to measure the movement of silicon DLT during positional change from supine to lateral for finding the proper positioning of DLT.
The investigators compare the difference of displacement between PVC DLT and silicon DLT distance during positional change from supine to lateral by fiberotic bronchoscope. And the investigators try to find proper position of PVC and silicon DLT, respectively, to perform safe and successful OLV during thoracic surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Daegu, Korea, Republic of, 42415
- Yeungnam University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient required differential lung ventilation in elective thoracic surgery American society of Anesthesiologist physical status(ASA PS) 1~3
Exclusion Criteria:
- emergency surgery, difficult intubation, poor lung function to accomplish OLV during surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PVC DLT
After the induction of general anesthesia, a left sided PVC DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope. The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position . The second set of measurements is taken in lateral position after position change. The displacement of PVC DLT is calculated from difference in tracheal distance between supine and lateral position. |
PVC DLT is type of double lumen tube that is composed of PVC
Other Names:
|
Active Comparator: silicon DLT
After the induction of general anesthesia, a left sided silicon DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope. The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position . The second set of measurements is taken in lateral position after position change. The displacement of silicon DLT is calculated from difference in tracheal distance between supine and lateral position. |
silicon DLT is type of double lumen tube that is composed of silicon
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the Incidence of Clinically Significant Displacement of DLTs During Change of Patient Position
Time Frame: from supine to lateral decubitus position during surgery
|
The tracheal distance was defined as the distance between the distal tip of the tracheal lumen and tracheal carina whereas the bronchial distance was defined as that between the bronchial carina and distal tip of endobronchial lumen.
The displacement of DLT was determined by changes in tracheal and bronchial distances, obtained by subtracting supine measurements from lateral measurements and subtracting measurements at start of surgery from measurements at the end of surgery, respectively.
Clinically significant displacement was defined when the DLT was deviated by more than 10 mm from the initial correct position, regardless of the direction of displacement.
|
from supine to lateral decubitus position during surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the Incidence of Critical Malposition of DLTs
Time Frame: from supine to lateral decubitus position
|
The displacement of DLT was determined by changes in tracheal and bronchial distances, obtained by subtracting supine measurements from lateral measurements and subtracting measurements at start of surgery from measurements at the end of surgery, respectively.
The critical malposition was defined when the DLT was required repostion for successful OLV during position change
|
from supine to lateral decubitus position
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Collaborators and Investigators
Investigators
- Principal Investigator: Sung Mee applejsm@gmail.com, MD, Yeungnam University College of Medicine
Publications and helpful links
General Publications
- Benumof JL, Partridge BL, Salvatierra C, Keating J. Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology. 1987 Nov;67(5):729-38. doi: 10.1097/00000542-198711000-00018.
- Desiderio DP, Burt M, Kolker AC, Fischer ME, Reinsel R, Wilson RS. The effects of endobronchial cuff inflation on double-lumen endobronchial tube movement after lateral decubitus positioning. J Cardiothorac Vasc Anesth. 1997 Aug;11(5):595-8. doi: 10.1016/s1053-0770(97)90011-2.
- Yoon TG, Chang HW, Ryu HG, Kwon TD, Bahk JH. Use of a neck brace minimizes double-lumen tube displacement during patient positioning. Can J Anaesth. 2005 Apr;52(4):413-7. doi: 10.1007/BF03016286.
Helpful Links
- Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology.
- The effects of endobronchial cuff inflation on double-lumen endobronchial tube movement after lateral decubitus positioning.
- Use of a neck brace minimizes double-lumen tube displacement during patient positioning.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YeungnamUDLT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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