Evaluation the Intracranial Volume Pressure Response in Increased Intracranial Pressure

• Conditions: Brain Injury; Intracranial Hypertension
• Interventions: Other: drainage of cerebrospinal fluid (CSF)

• Registration Number: NCT01126658
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

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 Timeline

• Study Start: 2008-12
• Primary Completion: 2010-02
• Status Verified: 2010-05
• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-20
• Last Update Submitted: 2010-05-20
• Last Update Posted: 2010-05-24
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All subjects act as their own contral	drainage of cerebrospinal fluid (CSF)	-

Primary Outcome Measures

Name	Time	Method
intracranial pressure	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 Once the ICP values exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg and the whole drainage procedure was completed within one minute.

Trial Locations

Locations (1)

Department of Neurosurgery,Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan