Brain InjuryNCT01126658
Evaluation the Intracranial Volume Pressure Response in Increased Intracranial Pressure
An observational study of Brain Injury and Intracranial Hypertension, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Intracranial Hypertension
- What is being tested?
- drainage of cerebrospinal fluid (CSF)
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2008to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: over 30 patients with severe brain injury and underwent bilateral external ventricular drainage in situ.
Who may be able to join
- Patients with severe brain damage
- Underwent bilateral external ventricular drainage (EVD)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Neurosurgery,Chang Gung Memorial Hospital
Taoyuan, 333
Shih-Tseng Lee, MD, 886-3-3281200 ext. 2119, yun0710@adm.cgmh.org.tw
Hung-Yi Lai, MD
About this study
Official title: 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.
Read the 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
- Being tested
- drainage of cerebrospinal fluid (CSF)
- Keywords
- pressure-volume curve, intracranial pressure, volume pressure response, pressure-volume relationship, mathematical model
- Medical subject headings
- Brain Injuries, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drainage of cerebrospinal fluid (CSF)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.
| Study group | Role | What they receive |
|---|---|---|
| All subjects act as their own contral | Not described Receives: Other: drainage of cerebrospinal fluid (CSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one minute.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startDec 2008
- Primary completionFeb 2010
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shih-Tseng Lee, MD, Study chair, Department of Neurosurgery,Chang Gung Memorial HospitalHung-Yi Lai, MD, Principal investigator, Department of Neurosurgery,Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126658
- Sponsor's protocol ID
- CMRPG 371581
- Status last verified
- May 2010
- First submitted
- 18 May 2010
- Last updated
- 24 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20714759
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Intracranial Volume Pressure Relationship in Increased Intracranial Pressure Patients by a Mathematic Manner
- ClinicalTrials.gov ID
- NCT01126658
- Acronym / sponsor ID
- CMRPG 371581
- Conditions
- Brain Injury, Intracranial Hypertension
- Keywords
- pressure-volume curve, intracranial pressure, volume pressure response, pressure-volume relationship, mathematical model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2010 (estimated)
- First posted
- 20 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects act as their own contral | – | Other: drainage of cerebrospinal fluid (CSF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- over 30 patients with severe brain injury and underwent bilateral external ventricular drainage in situ.
Key inclusion criteria (2 listed)
- Patients with severe brain damage
- Underwent bilateral external ventricular drainage (EVD)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | All subjects act as their own contral |
Primary outcome
intracranial pressure
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2010.
- Derived from this study: PubMed 20714759Lai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Tseng Lee, MD study chair
Department of Neurosurgery,Chang Gung Memorial Hospital
Hung-Yi Lai, MD principal investigator
Department of Neurosurgery,Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury and Intracranial Hypertension, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shih-Tseng Lee, MD (886-3-3281200 ext. 2119, yun0710@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracranial pressure (time frame: one minute.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01126658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2010.