Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement

Brief Title

Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement

Official Title

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

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 Type

Observational


Primary Outcome

Rate and Severity of Complications Related Associated with CSFD placement


Condition

Cerebrospinal Fluid Drainage

Intervention

Blind CSF Drain Placement


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

300

Start Date

August 3, 2020

Completion Date

December 2021

Primary Completion Date

December 2021

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Harendra Arora, MD, MBA, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04505423

Organization ID

20-0727


Responsible Party

Sponsor

Study Sponsor

University of North Carolina, Chapel Hill

Collaborators

 UNC Medical Alumni

Study Sponsor

Harendra Arora, MD, MBA, Principal Investigator, University of North Carolina, Chapel Hill


Verification Date

February 2021