UNC Chapel Hill
Chapel Hill, North Carolina, 27514, United States
NCT Number: NCT04505423
The purpose of this study is to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Chapel Hill, North Carolina, 27514, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CSF Drain placement without fluoroscopic image guidance.
CSF Drain placement utilizing fluoroscopic image guidance.
Time frame: From admission to discharge, up to 2 weeks
The rate and severity of complications associated with CSFD placement with or without fluoroscopic guidance via a chart review. This will be assessed using quantitative methods such as vital signs and lab-work drawn relating to the procedure as well as qualitative variables through clinical notes.
University of North Carolina, Chapel Hill
Other
Evaluation of Outcomes Related to Cerebrospinal Fluid Drains Placed Either With or Without Fluoroscopic Guidance for Aortic Surgery
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.
Published trials that share one or more normalized conditions with this study.
NCT04145544
Cerebrospinal Fluid Leak, Craniocerebral Trauma
Genk, Belgium
View Trial DetailsNCT04923867
Cerebrospinal Fluid Leak, Craniocerebral Trauma
Aurora, Colorado, United States
View Trial DetailsNCT04086550
Cerebrospinal Fluid Leak, Craniocerebral Trauma
Palo Alto, California, United States
View Trial DetailsNCT00842049
Aneurysm, Brain Diseases
Leeds, West Yorkshire, United Kingdom
View Trial Details