Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement

Cerebrospinal Fluid Drainage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505423
• Other study ID #: 20-0727
• Status: Completed
• Start date: August 3, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: February 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrospinal Fluid Drainage
• Cerebrospinal Fluid Leak

Intervention

Procedure:
• Blind CSF Drain Placement
CSF Drain placement without fluoroscopic image guidance.
• Fluoroscopy-guided Drain Placement
CSF Drain placement utilizing fluoroscopic image guidance.

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	UNC Medical Alumni

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and Severity of Complications Related Associated with CSFD placement	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.	From admission to discharge, up to 2 weeks