Evaluation the Intracranial Volume Pressure Response in Increased Intracranial Pressure

NCT ID: NCT01126658

Last Updated: 2010-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-06-30

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).

Conditions

Brain Injury; Intracranial Hypertension

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

All subjects act as their own contral

drainage of cerebrospinal fluid (CSF)

Intervention Type: OTHER

Once the ICP exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg.

Interventions

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Once the ICP exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang Gung Medical Research Council

Principal Investigators

Shih-Tseng Lee, MD

Role: STUDY_CHAIR

Department of Neurosurgery,Chang Gung Memorial Hospital

Hung-Yi Lai, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery,Chang Gung Memorial Hospital

Locations

Department of Neurosurgery,Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Shih-Tseng Lee, MD

Role: CONTACT

yun0710@adm.cgmh.org.tw

886-3-3281200 ext. 2119

Facility Contacts

Shih-Tseng Lee, MD

Role: primary

yun0710@adm.cgmh.org.tw

886-3-3281200 ext. 2119

References

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.

Reference Type: DERIVED

PMID: 20714759 (View on PubMed)

Other Identifiers

CMRPG 371581

Identifier Type: -

Identifier Source: org_study_id