To compare the accuracy of HeadSense*s non-invasive ICP monitor with the readings from the invasive ICP monitor.
ID
Source
Brief title
Condition
- Increased intracranial pressure and hydrocephalus
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Demonstrate the HS-1000 performance and accuracy in ICP monitoring
Secondary outcome
ergonomics and functionality
Background summary
Patients with severe traumatic brain injury (TBI) are admitted to the ICU.
Under certain condition (such as a impaired consciousness) the intracranial
pressure is measured. An increase in the intracranial pressure might suggest
secondary neurological deterioration and is considered an alarming symptom.
Current practice is to insert an invasive monitor through a burr hole in the
skull with the risk of bleeding and infection. Using a new type of ICP monitor
(Headsense) it is possible to measure ICP non-invasively through an acoustic
signal
Study objective
To compare the accuracy of HeadSense*s non-invasive ICP monitor with the
readings from the invasive ICP monitor.
Study design
A comparison of ICP values from both invasive ICP monitor, and HeadSense*s
non-invasive ICP monitor.
Study burden and risks
This project is a pilot study. Family of patients will be asked for consent.
The measurement is non-invasive without any known negative side effects for the
patients. The measurements will not interfere with current best practice.
Readings from the headsense will not be used for clinical decisions. The
patient will not benefit from the extra measurements
Hilvarenbeekseweg 60
Tilburg 5022 GC
NL
Hilvarenbeekseweg 60
Tilburg 5022 GC
NL
Listed location countries
Age
Inclusion criteria
severe traumatic brain injury, age18-85 years, ICU admitted, invasive ICP monitor
Exclusion criteria
ear infection, pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48862.028.14 |