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Completed

NCT Number: NCT04505423

Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement

The purpose of this study is to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Chapel Hill

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Blind CSF Drain Placement

Procedure

CSF Drain placement without fluoroscopic image guidance.

Fluoroscopy-guided Drain Placement

Procedure

CSF Drain placement utilizing fluoroscopic image guidance.

Primary outcomes

  1. Rate and Severity of Complications Related Associated with CSFD placement

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • UNC Medical Alumni

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 10, 2020
Registry last updated
Feb 25, 2022

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.

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