Evaluation the Intracranial Volume Pressure Response in Increased Intracranial Pressure

Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01126658
• Other study ID #: CMRPG 371581
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2010
• Last updated: May 20, 2010
• Start date: December 2008
• Est. completion date: June 2010

Study information

• Verified date: May 2010
• Source: Chang Gung Memorial Hospital
• Contact: Shih-Tseng Lee, MD
• Phone: 886-3-3281200
• Email: yun0710[@]adm.cgmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: June 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with severe brain damage

• Underwent bilateral external ventricular drainage (EVD)

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injury
• Intracranial Hypertension

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department of Neurosurgery,Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intracranial pressure	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.	No