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
NCT number | NCT04505423 |
Other study ID # | 20-0727 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 3, 2020 |
Est. completion date | May 1, 2021 |
Verified date | February 2022 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.
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 |
Country | Name | City | State |
---|---|---|---|
United States | UNC Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | UNC Medical Alumni |
United States,
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
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 |