NCT01126658

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

May 24, 2010

Status Verified

May 1, 2010

Enrollment Period

1.2 years

First QC Date

May 18, 2010

Last Update Submit

May 20, 2010

Conditions

Keywords

pressure-volume curveintracranial pressurevolume pressure responsepressure-volume relationshipmathematical model

Outcome Measures

Primary Outcomes (1)

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 Once the ICP values exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg and the whole drainage procedure was completed within one minute.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

Study Arms (1)

All subjects act as their own contral

Other: drainage of cerebrospinal fluid (CSF)

Interventions

Once the ICP exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg.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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery,Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Brain InjuriesIntracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Shih-Tseng Lee, MD

    Department of Neurosurgery,Chang Gung Memorial Hospital

    STUDY CHAIR
  • Hung-Yi Lai, MD

    Department of Neurosurgery,Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shih-Tseng Lee, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2010

First Posted

May 20, 2010

Study Start

December 1, 2008

Primary Completion

February 1, 2010

Study Completion

June 1, 2010

Last Updated

May 24, 2010

Record last verified: 2010-05

Locations