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

NCT ID: NCT00886054

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Head Injury Intracerebral Hemorrhage Ischemic Stroke Subarachnoid Hemorrhage Brain Tumor Hydrocephalus

Keywords

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Transcranial Doppler Transcranial color-coded duplex sonography Neurocritical patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neurocritical patients

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Traumatology, National Taiwan University Hospital

Principal Investigators

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Yi-Hsin Tsai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Traumatology, National Taiwan University Hospital

Locations

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Department of Traumatology, National Taiwain University Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

References

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Other Identifiers

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97WFA0102463

Identifier Type: -

Identifier Source: secondary_id

200901010R

Identifier Type: -

Identifier Source: org_study_id