Overview

This trial is active, not recruiting.

Conditions endotracheal tube wrongly placed during anesthetic procedure, surgical procedure, unspecified
Treatments pvc dlt, silicon dlt
Sponsor Yeungnam University College of Medicine
Start date February 2016
End date December 2016
Trial size 108 participants
Trial identifier NCT02691468, YeungnamUDLT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Active Comparator)
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 PVC double-lumen tube
PVC DLT is type of double lumen tube that is composed of PVC
(Active Comparator)
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 silicon double-lumen tube
silicon DLT is type of double lumen tube that is composed of silicon

Primary Outcomes

Measure
Measurement displacement amount of PVC and silicon DLT during position change
time frame: Immediately after positioning from supine to lateral

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Comparison of Displacement Between Polyvinyl Chloride(PVC) and Silicon Double-Lumen Endobronchial Tubes(DLT) During Change of Position
Principal investigator Sung Mee applejsm@gmail.com, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Yeungnam University College of Medicine.