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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00886054
• Other study ID #: 200901010R
• Secondary ID: 97WFA0102463
• Status: Active, not recruiting
• Phase: N/A
• First received: April 20, 2009
• Last updated: December 20, 2009
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2009
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Tumor
• Cerebral Hemorrhage
• Head Injury
• Hemorrhage
• Hydrocephalus
• Intracerebral Hemorrhage
• Ischemic Stroke
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
Taiwan	Department of Traumatology, National Taiwain University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references