Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04505423
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2020-08-05
Brief Title:
Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Evaluation of Outcomes Related to Cerebrospinal Fluid Drains Placed Either With or Without Fluoroscopic Guidance for Aortic Surgery
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance
Detailed Description:
Patients undergoing thoracoabdominal aortic aneurysm TAAA repair are at risk of suffering devastating spinal cord injury SCI rendering them with a permanent neurologic deficit paraplegia or paraparesis Despite huge success over the last several decades with the introduction of innovative protective maneuvers such as the use of cerebrospinal fluid drains CSFDs the rate of these complications remains around 5 Spinal cord perfusion can be compromised during aortic surgery and the intrathecal decompression achieved by CSFDs functions to increase the pressure gradient of blood flow thereby optimizing spinal cord perfusion during aortic surgery There are two methods commonly used to place cerebrospinal fluid drains blind placement and with fluoroscopic guidance Prior to 2016 CSFDs at UNC hospital were primarily placed without image guidance However hospital policy then transitioned to having all CSFDs placed using fluoroscopic guidance To the investigators knowledge there are no reported studies directly comparing clinical outcomes of CSFDs placed by these methods Given the increased cost and radiation exposure associated with the use of fluoroscopy a better understanding of comparative outcomes has great potential clinical value Therefore the investigators propose to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None