Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||In Vivo Analysis of Intradural Pressure Variation With Patient Positioning|
- 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.
- Safety measurements of one position over another.
|Study Start Date:||September 2005|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231374
|United States, Georgia|
|Emory Orthopaedics & Spine Center|
|Atlanta, Georgia, United States, 30329|
|Principal Investigator:||Tim Yoon, M.D.||Emory University|