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Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning

This study has been withdrawn prior to enrollment.
(Difficulty in recruiting patients for the study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00231374
First Posted: October 4, 2005
Last Update Posted: January 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
S. Tim Yoon, M.D., Emory University
October 3, 2005
October 4, 2005
January 9, 2014
September 2005
September 2007   (Final data collection date for primary outcome measure)
  • CSF pressure measurements on 5 patients having a cervical myelogram in 3 positions.
  • CSF pressure measurements on 5 patients having a lumbar myelogram in 2 positions.
Same as current
Complete list of historical versions of study NCT00231374 on ClinicalTrials.gov Archive Site
Safety measurements of one position over another.
Same as current
Not Provided
Not Provided
 
Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning
In Vivo Analysis of Intradural Pressure Variation With Patient Positioning
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Back Pain
Procedure: Myelogram
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2007
September 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Need a lumbar or cervical myelogram as part of routine care.

Exclusion Criteria:

  • Not needing a myelogram in the cervical or lumbar spine.
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00231374
0489-2005
Not Provided
Not Provided
Not Provided
S. Tim Yoon, M.D., Emory University
Emory University
Not Provided
Principal Investigator: Tim Yoon, M.D. Emory University
Emory University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP