Brain Injuries, Intracranial Hypertension
Conditions
Keywords
intracranial pressure, noninvasive monitoring
Brief summary
Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical information. HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP waveform safely and accurately with minimal discomfort to patients, compared to standard invasive ICP monitoring procedures used at the participating institutions.
Detailed description
A study will be conducted on 100 patients who undergo invasive ICP measurement due to suspected ICP elevation, regardless to etiology. Each enrolled patient will be monitored with the HS-1000 device and data will be collected throughout the entire procedure. Once the data collection is done, results of the non-invasive measurements will be analyzed accordingly. The end-point of the study is to collect at least half an hour of measurements for each participant.
Interventions
DEVICEHS-1000
Sponsors
Oslo University Hospital
HeadSense Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult men and women subjects, aged 18 years old and over at screening visit * Subjects with neuropathology that the principal investigator considers including in this study. * Survival expectancy greater than 72 hours * Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol * Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study
Exclusion criteria
* Local ear infection * Known allergy or hypersensitivity to any of the test materials or contraindication to test materials * For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding * Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s) * Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of ICP values obtained by the HS device that correlate to ICP using current standards | 30 minutes |
Countries
Norway
Outcome results
None listed