Displacement Between PVC and Silicon DLT

Surgical Procedure, Unspecified Clinical Trial

Official title:

Comparison of Displacement Between Polyvinyl Chloride(PVC) and Silicon Double-Lumen Endobronchial Tubes(DLT) During Change of Position

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691468
• Other study ID #: YeungnamUDLT
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: August 2021
• Source: Yeungnam University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare difference of displacement between Polyvinyl Chloride(PVC) and Silicon double-lumen endobronchial tubes(DLTs) during changing position from supine to lateral in thoracic surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Endotracheal Tube Wrongly Placed During Anesthetic Procedure
• Surgical Procedure, Unspecified

Intervention

Device:
• PVC DLT
PVC DLT is type of double lumen tube that is composed of PVC
• silicon DLT
silicon DLT is type of double lumen tube that is composed of silicon

Locations

Country	Name	City	State
Korea, Republic of	Yeungnam University Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Incidence of Clinically Significant Displacement of DLTs During Change of Patient Position	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
Secondary	the Incidence of Critical Malposition of DLTs	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

External 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.