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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00886054
First received: April 20, 2009
Last updated: December 20, 2009
Last verified: December 2009
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 30
Study Start Date: December 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Neurocritical patients
Neurocritical patients including those sustaining head injury, cerebrovascular events (such as intracerebral hemorrhage, subarachnoid hemorrhage, etc.), brain tumor, or 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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
McCartney JP, Thomas-Lukes KM, Gomez CR. Introduction to Transcranial Doppler. In: Handbook of transcranial Doppler. New York: Springer-Verlag, 1997;1-13.
Baumgartner RW. Transcranial color-coded duplex sonography. Journal of Neurology. 246(8):637-47, 1999 Aug.
Lindegaard K-F. Indices of pulsatility. In: Newell DW, Aaslid RA, eds. Transcranial Doppler. New York: Raven Press, 1992:67-82.

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
Study First Received: April 20, 2009
Last Updated: December 20, 2009
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on August 18, 2014