Clinical trial NCT04505423: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrospinal Fluid Drainage
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: UNC Medical Alumni
First posted: 2020-08-10
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UNC Hospital System Patients

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.

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

Primary outcomes:
measure: Rate and Severity of Complications Related Associated with CSFD placement
timeFrame: From admission to discharge, up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Harendra Arora, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Svensson LG, Crawford ES, Hess KR, Coselli JS, Safi HJ. Experience with 1509 patients undergoing thoracoabdominal aortic operations. J Vasc Surg. 1993 Feb;17(2):357-68; discussion 368-70.
citation: Safi HJ, Estrera AL, Miller CC, Huynh TT, Porat EE, Azizzadeh A, Meada R, Goodrick JS. Evolution of risk for neurologic deficit after descending and thoracoabdominal aortic repair. Ann Thorac Surg. 2005 Dec;80(6):2173-9; discussion 2179. doi: 10.1016/j.athoracsur.2005.05.060.