NCT04505423

Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement

Evaluation of Outcomes Related to Cerebrospinal Fluid Drains Placed Either With or Without Fluoroscopic Guidance for Aortic Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 302 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebrospinal Fluid Drainage

Interventions

Type	Name	Description
PROCEDURE	Blind CSF Drain Placement	CSF Drain placement without fluoroscopic image guidance.
PROCEDURE	Fluoroscopy-guided Drain Placement	CSF Drain placement utilizing fluoroscopic image guidance.

Timeline

• Start date: 2020-08-03
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2020-08-10
• Last updated: 2022-02-25

Locations

1 site across 1 country: United States