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The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients

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ClinicalTrials.gov Identifier: NCT00886054
Recruitment Status : Unknown
Verified December 2009 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 22, 2009
Last Update Posted : December 23, 2009
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital

Brief Summary:
The purpose of this study is to use transcranial Doppler (TCD) to predict intracranial pressure (ICP) and clinical outcome of neurocritical patients.

Condition or disease
Head Injury Intracerebral Hemorrhage Ischemic Stroke Subarachnoid Hemorrhage Brain Tumor Hydrocephalus

Detailed Description:
Transcranial Doppler (TCD) and Transcranial color-coded duplex sonography (TCCS) play an important part in neurocritical monitoring systems. Currently there are studies using flow velocities and pulsatility index (PI) to predict intracranial pressure (ICP) and clinical outcome. But the use of B-mode in such prediction is not yet investigated. The purposes of this study are to establish the correlation among clinical data, CT findings and information collected by TCCS, and to predict ICP and neurological outcome using such information. The focus would be on 3rd ventricle size, midline shift and anteroposterior-transverse ration of midbrain (midbrain index) obtained by B-mode of TCCS. This study is a prospective clinical study targeting on 30 neurocritical patients admitted to intensive care units in one year. The timing of performance of TCCS will be (1) within 6 hours after admission, (2) within 6 hours after each CT examination, and (3) when ICP is higher than 20 mmHg for more than 5 minutes. Glasgow coma scale (GCS), heart rate, blood pressure (systolic, diastolic, and mean), body temperature, central venous pressure (CVP), brain temperature, ICP, cerebral perfusion pressure (CPP), mean velocity (MV) of bilateral middle cerebral arteries (MCAs), PI, midline shift, 3rd ventricular dimension, anteroposterior to transverse ratio of midbrain (midbrain index, MI) are recorded. The latter three parameters are also obtained from CT scans, and compared with those obtained from TCCS. Outcome is evaluated with extended Glasgow outcome scale (GOSE), and analyzed with previous records. This study is going to prove that TCCS is a safe, convenient, real-time and cheap tool in clinical care for neurocritical patients. It also provides prediction of ICP and clinical outcome.

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients
Study Start Date : December 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010


Group/Cohort
Neurocritical patients
Neurocritical patients including those sustaining head injury, cerebrovascular events (such as intracerebral hemorrhage, subarachnoid hemorrhage, etc.), brain tumor, or hydrocephalus.




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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted via emergency room for neurosurgical emergency, such as trauma, stroke, etc.
Criteria

Inclusion Criteria:

  • Aged 16 to 80 years
  • Neurocritical patient (head injury, hemorrhagic or ischemic stroke, subarachnoid hemorrhage, etc.) who was admitted to intensive care unit and had undergone intracranial pressure monitoring

Exclusion Criteria:

  • associated with multiple organ impairment or failure
  • single organ failure prior to neurocritical condition, such as cardiac, hepatic, or renal failure
  • associated with severe infection or sepsis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886054


Locations
Taiwan
Department of Traumatology, National Taiwain University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Yi-Hsin Tsai, M.D. Department of Traumatology, National Taiwan University Hospital

Publications of Results:
McCartney JP, Thomas-Lukes KM, Gomez CR. Introduction to Transcranial Doppler. In: Handbook of transcranial Doppler. New York: Springer-Verlag, 1997;1-13.
Lindegaard K-F. Indices of pulsatility. In: Newell DW, Aaslid RA, eds. Transcranial Doppler. New York: Raven Press, 1992:67-82.

Other Publications:

Responsible Party: Tsai, Yi-Hsin, Department of Traumatology, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00886054     History of Changes
Other Study ID Numbers: 200901010R
97WFA0102463
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by National Taiwan University Hospital:
Transcranial Doppler
Transcranial color-coded duplex sonography
Neurocritical patients

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Cerebral Hemorrhage
Hydrocephalus
Craniocerebral Trauma
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Trauma, Nervous System
Wounds and Injuries