Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231374
Status:
WITHDRAWN
Last Update Posted:
2014-01-09
First Post:
2005-10-03
Brief Title:
Measure of Cerebrospinal Fluid CSF Pressure Variation With Patient Positioning
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
In Vivo Analysis of Intradural Pressure Variation With Patient Positioning
Status:
WITHDRAWN
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty in recruiting patients for the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study looking at pressure changes in the fluid that surrounds the spine when a person is positioned in 2-3 different ways
Detailed Description:
Volunteers who need a myelogram of their spine as part of their routine medical care are being asked to be in this study A myelogram is an imaging study with x-rays after an agent is put into the spine that shows spinal fluid on the x-ray It requires insertion of a needle into the cerebrospinal fluid CSF inside the spine CSF is a bodily fluid that bathes the brain spinal cord and nerve roots This study is being conducted to measure CSF pressure changes with different patient positioning
We are motivated to do this research study to better treat patients who develop a spinal fluid leak during a myelogram or other spine procedure The tissue that holds the cerebrospinal fluid CSF is called the dura During surgery or other procedures the dura can develop a tear Dural tears can result in a leakage of CSF CSF leaks are a recognized complication of spinal surgery Currently there is no evidence on whether or not a specific postoperative spine position is beneficial especially for cervical neck spine CSF leaks The process of dural healing after a dural tear is influenced by CSF pressure High CSF pressure may inhibit dural healing We want to find the patient position sitting lying down or reclining that reduces the CSF pressure the most To do this we want to attach a pressure monitor to the needle that is normally placed in the spine for a myelogram and measure the CSF pressure
We are motivated to do this research study to better treat patients who develop a spinal fluid leak during a myelogram or other spine procedure The tissue that holds the cerebrospinal fluid CSF is called the dura During surgery or other procedures the dura can develop a tear Dural tears can result in a leakage of CSF CSF leaks are a recognized complication of spinal surgery Currently there is no evidence on whether or not a specific postoperative spine position is beneficial especially for cervical neck spine CSF leaks The process of dural healing after a dural tear is influenced by CSF pressure High CSF pressure may inhibit dural healing We want to find the patient position sitting lying down or reclining that reduces the CSF pressure the most To do this we want to attach a pressure monitor to the needle that is normally placed in the spine for a myelogram and measure the CSF pressure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None