Evaluation the Intracranial Volume Pressure Response in Increased Intracranial Pressure

May 20, 2010 updated by: Chang Gung Memorial Hospital

Evaluation of the Intracranial Volume Pressure Relationship in Increased Intracranial Pressure Patients by a Mathematic Manner

The purpose of this study is to discover a mathematic equation to express the intracranial pressure-volume (P-V) curve and a single indicator to reflect the status of the curve.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Monitoring of intracranial pressure (ICP) has been used in the management of patients with increased ICP, or in whom increased ICP was suspected. ICP depends on the relative constancy of total volume inside the skull, comprising cerebrospinal fluid (CSF), blood, and brain tissue. The changes of CSF volume affect the ventricular fluid pressure and defined it as volume pressure response (VPR). The shape or curve of the intracranial volume-pressure (V-P) relationship is well known in daily neurosurgical practice. If the P-V curve can be expressed by mathematic manner, then there should be an indicator to reflect the status of the curve. This study is conducted in order to understand the difference of each P-V curve in patients with increased intracranial pressure. The individual VPR values have been tested with three mathematical models (linear, parabolic and exponential regression equation).

Study Type

Observational

Enrollment (Anticipated)

41

Contacts and Locations

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

Study Contact

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Department of Neurosurgery,Chang Gung Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Hung-Yi Lai, MD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

over 30 patients with severe brain injury and underwent bilateral external ventricular drainage in situ.

Description

Inclusion Criteria:

  • Patients with severe brain damage
  • Underwent bilateral external ventricular drainage (EVD)

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All subjects act as their own contral
Other: drainage of cerebrospinal fluid (CSF)
Once the ICP exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intracranial pressure
Time Frame: one minute.
The ICP values were obtained from the bedside ICU monitor. Once the ICP values exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg and the whole drainage procedure was completed within one minute.
one minute.

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: Shih-Tseng Lee, MD, Department of Neurosurgery,Chang Gung Memorial Hospital
  • Principal Investigator: Hung-Yi Lai, MD, Department of Neurosurgery,Chang Gung Memorial Hospital

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.

General Publications

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

December 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Estimate)

May 24, 2010

Last Update Submitted That Met QC Criteria

May 20, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG 371581

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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