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

December 20, 2009 updated by: National Taiwan University Hospital
The purpose of this study is to use transcranial Doppler (TCD) to predict intracranial pressure (ICP) and clinical outcome of neurocritical patients.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • Department of Traumatology, National Taiwain University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted via emergency room for neurosurgical emergency, such as trauma, stroke, etc.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Yi-Hsin Tsai, M.D., Department of Traumatology, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 21, 2009

First Posted (Estimate)

April 22, 2009

Study Record Updates

Last Update Posted (Estimate)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 20, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200901010R
  • 97WFA0102463

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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