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

January 8, 2014 updated by: S. Tim Yoon, M.D., Emory University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory Orthopaedics & Spine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
Safety measurements of one position over another.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Tim Yoon, M.D., Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ACTUAL)

September 1, 2007

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

October 3, 2005

First Submitted That Met QC Criteria

October 3, 2005

First Posted (ESTIMATE)

October 4, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0489-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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