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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

May 18, 2010
May 20, 2010
December 2008
February 2010   (final data collection date for primary outcome measure)
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 Once the ICP values exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg and the whole drainage procedure was completed within one minute.
Same as current
Complete list of historical versions of study NCT01126658 on ClinicalTrials.gov Archive Site
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Evaluation the Intracranial Volume Pressure Response in Increased Intracranial Pressure
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.

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).

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

  • Brain Injury
  • Intracranial Hypertension
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.
All subjects act as their own contral
Intervention: Other: drainage of cerebrospinal fluid (CSF)
Lai HY, Lee CY, Hsu HH, Lee ST. The intracranial volume pressure response in increased intracranial pressure patients: Part 1. Calculation of the volume pressure indicator. Acta Neurochir (Wien). 2012 Dec;154(12):2271-5; discussion 2275. doi: 10.1007/s00701-010-0765-8. Epub 2010 Aug 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
41
June 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

-

Both
18 Years and older
No
Contact: Shih-Tseng Lee, MD 886-3-3281200 ext 2119 yun0710@adm.cgmh.org.tw
Taiwan
 
NCT01126658
CMRPG 371581
Yes
Chang Gung Memorial Hospital, Chang Gung Medical Research Council
Chang Gung Memorial Hospital
Not Provided
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
Chang Gung Memorial Hospital
May 2010

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