Evaluation the Intracranial Volume Pressure Response in Increased Intracranial Pressure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01126658
First received: May 18, 2010
Last updated: May 20, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention
Brain Injury
Intracranial Hypertension
Other: drainage of cerebrospinal fluid (CSF)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Intracranial Volume Pressure Relationship in Increased Intracranial Pressure Patients by a Mathematic Manner

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • intracranial pressure [ Time Frame: one minute. ] [ Designated as safety issue: No ]
    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 Once the ICP values exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg and the whole drainage procedure was completed within one minute.


Estimated Enrollment: 41
Study Start Date: December 2008
Estimated Study Completion Date: June 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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Once the ICP exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01126658

Contacts
Contact: Shih-Tseng Lee, MD 886-3-3281200 ext 2119 yun0710@adm.cgmh.org.tw

Locations
Taiwan
Department of Neurosurgery,Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Shih-Tseng Lee, MD    886-3-3281200 ext 2119    yun0710@adm.cgmh.org.tw   
Principal Investigator: Hung-Yi Lai, MD         
Sponsors and Collaborators
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
  More Information

No publications provided by Chang Gung Memorial Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chang Gung Memorial Hospital, Chang Gung Medical Research Council
ClinicalTrials.gov Identifier: NCT01126658     History of Changes
Other Study ID Numbers: CMRPG 371581
Study First Received: May 18, 2010
Last Updated: May 20, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
pressure-volume curve
intracranial pressure
volume pressure response
pressure-volume relationship
mathematical model

Additional relevant MeSH terms:
Hypertension
Brain Injuries
Intracranial Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014