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NCT Number: NCT02691468

Displacement Between PVC and Silicon DLT

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.

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Key information

Conditions

Endotracheal Tube Wrongly Placed During Anesthetic Procedure Surgical Procedure, Unspecified

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeungnam University Hospital

Daegu, 42415, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PVC DLT

Device

PVC DLT is type of double lumen tube that is composed of PVC

Other names: PVC double-lumen tube

silicon DLT

Device

silicon DLT is type of double lumen tube that is composed of silicon

Other names: silicon double-lumen tube

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Yeungnam University College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2016
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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