Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement

Completed

• Conditions: Cerebrospinal Fluid Drainage

• Registration Number: NCT04505423
• Lead Sponsor: University of North Carolina, Chapel Hill

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 Timeline

• Study Start: 2020-08-03
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-10
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

• CSF drain placed from 2010 to present prior to undergoing aortic surgery

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Exclusion Criteria

• Patients under 18 years of age
• Patients undergoing emergency procedures

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate and Severity of Complications Related Associated with CSFD placement	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.

Trial Locations

Locations (1)

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States