Intracranial Pressure, Intracranial Pressure Changes
Conditions
Brief summary
Elevated intracranial pressure is a common complication of brain injury which means that the pressure within the skull rises above normal levels. The negative impact of increased intracranial pressure (ICP) on the prognosis of patients has been strongly shown in numerous studies and ICP-based treatment is associated with an important reduction of risk of death. Invasive ICP measurement methods are nowadays a standard of care in severe brain injury. The two available ways of measuring ICP require neurosurgical procedure to implant a catheter and probes within the brain and present risks and complications for the patient, such as infections and intracranial bleeding. In addition, invasive recording of ICP requires neurosurgical expertise and intensive care unit (ICU) facilities, limiting the application of ICP measurements to patients of the acute neuro-ICU (neuro-Intensive Care Unit) with acute brain damage requiring close surveillance to prevent further deterioration of neural tissue and disability. Non-invasive ICP monitoring benefits include no risk of complications seen in invasive monitoring, helping in deciding which patient needs invasive ICP monitoring, and providing ongoing long-term measurements of ICP without having to insert a new device every time. Although many non-invasive ICP measurement methods have been explored, to date, none of them have shown clinical success or usefulness. One under-explored window to ICP is the orbital vein, a small blood vessel located near your eye, which we think could provide a direct link to the intracranial pressure. The study device, called the CPMX3 system, is a non-invasive method to measure pressure in a superficial periorbital vein.
Interventions
DEVICECPMX3
CPMX3 periorbital vein pressure measurement
Sponsors
Compremium AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * Age \> 18 * Equipped with an invasive ICP monitor as part of standard of care
Exclusion criteria
* Presence of facial and/or skull trauma that could hinder placement of the pneumatic mask or contraindicate ultrasound on the forehead * History of recent cranial surgery or hemicraniectomy * Active bleeding (proven or suspected) * History or known pathological condition or injury linked to the orbital socket influencingvenous outflow (e.g. Grave disease, tumor, inflammation, trauma, glaucoma, etc.) * History, or known vein stenosis in ophthalmic veins/cavernous sinus * Any other condition that would interfere with measurement technique and routine clinical care according to the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported adverse events | up to 7 days | — |
| Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported Device Deficiencies (DDs) | Up to 7 days | — |
| Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported Serious Adverse Device Effects (SADEs) | Up to 7 Days | — |
| Preliminary accuracy of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, measured in mmHg | up to 7 days | Preliminary accuracy will be assessed by recording paired measurements of venous occlusion pressure of the periorbital vein when isolated from its surrounding network and invasive ICP measurements from the standard of care invasive ICP monitor in mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of finding and compressing the target periorbital vein as reported by the investigator using a visual analog scale 0 to 3 | up to 7 days | As reported by investigator using a visual analog scale score from 0 to 3 (0: not able to visualize the vein, 3: perfectly able to visualize) |
| The tolerability of the non-invasive measurement process, evaluated via a dedicated patient questionnaire on patient comfort | up to 7 days | Evaluated by each participant before study termination through a dedicated questionnaire |
Countries
United States
Contacts
Primary ContactDamon Judges
Backup ContactCharlotte Moerman
Outcome results
None listed