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Clinical Validation of a Transcranial Doppler-Based Noninvasive Intracranial Pressure Meter: A Prospective
Eric M Bershad1, Aashish Anand2, Stacia M DeSantis3
1Department of Neurology, Baylor College of Medicine, Houston, Texas, USA; Center for Space Medicine, Baylor College of Medicine, Houston, Texas, USA.
World Neurosurgery
|January 3, 2016
Summary
The Vittamed ICP meter shows fair agreement for noninvasive intracranial pressure (ICP) measurement. Its wide agreement limits suggest it may be best used alongside other screening methods.
Area of Science:
- Neurosurgery
- Medical Devices
- Diagnostic Technology
Background:
- Noninvasive intracranial pressure (ICP) measurement is crucial for neurological patients.
- The Vittamed ICP meter, an ultrasound device, has shown prior agreement with invasive methods.
- Previous studies often excluded patients with elevated ICP levels.
Purpose of the Study:
- To validate the Vittamed ICP meter independently.
- To assess its accuracy across a wide range of ICP values.
- To compare ultrasound-based ICP measurement with invasive lumbar CSF pressure.
Main Methods:
- Prospective, cross-sectional study design.
- Simultaneous measurement of ICP using the Vittamed device and invasive lumbar CSF pressure.
- Blinded operators and analysis via Bland-Altman plots, Pearson correlation, and ROC curves.
Main Results:
- Twenty-four paired measurements were obtained.
- Mean absolute difference was 4.5 mmHg, with 95% limits of agreement from -10.5 to +11.0 mmHg.
- Sensitivity and specificity for ICP >20 mmHg were 0.73 and 0.77, respectively.
Conclusions:
- The Vittamed ICP meter demonstrated fair agreement with invasive ICP measurement.
- Wide limits of agreement restrict its use as a standalone diagnostic tool.
- Potential utility in conjunction with other screening methods; future improvements may enhance accuracy.

