Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients

Study Overview
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Brief Summary
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Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain temperature monitoring and ventricular cerebrospinal fluid (CSF) drainage in brain-injured patients.

Official Title
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Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device That Allows the Measurement of Regional Cerebral Blood Flow (rCBF), Intracranial Pressure (ICP), Brain Temperature Monitoring and Ventricular Cerebrospinal Fluid (CSF) Drainage in Brain-injured Patients

Conditions
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Brain Injuries

Intervention / Treatment
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* Device: Placement of the CBMS Probe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female patient, aged 18 - 75 years Brain injured patients with acute intracranial hemorrhage (including aneurysmal subarachnoid hemorrhage (SAH) and spontaneous intracerebral hemorrhage (ICH)) who are admitted to the ICU and have an indication for ICP monitoring and CSF drainage, as per standard patient care Informed consent obtained for research in emergency situations according to HRA art. 30 & 31 at time of inclusion Exclusion Criteria: Known kidney disease, defined as plasma creatinine > 120 μmol/l Known liver disease, defined as AST > 200 IU/L Over-active thyroid or benign tumors of the thyroid History of allergic disorders, including allergic reactions, against contrast agents containing iodine, or against ICG Patients which have received one of the following medications before being admitted to ICU: Haloperidol, Meperidine, Methadone, Morphine, Phenobarbital and Rifamycin. Patients with wounds or scars including the front orbital region. Cerebrospinal fluid infection or signs of meningo-encephalitis Anemia (hemoglobin < 10 g/dl) or Thalassemia Carbon monoxide poisoning Acquired pathological or congenital disorders of the cerebral system, being clinically significant, respectively interfering in the investigator's opinion with the conduct of study Documented history of bleeding, clotting or coagulation disorders Patients who are not suitable for a CT perfusion Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this clinical investigation or will not comply with requirements of the study Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation Pre-existing disability and/or legal representative Patients who are kept lawfully in an institution Participation in another interventional clinical investigation within the last 30 days before start of treatment History of, respectively diagnosis of pregnancy, or breastfeeding patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBMS<br> | Device: Placement of the CBMS Probe<br>* Patients will be treated according to standard care in place at the investigation site, when intra-ventricular drainage is needed. Patients will receive the new multifunctional device (CBMS Probe) instead of the single function device generally used. Drainage will be performed by routine standards. Temperature, intracranial pressure and cerebral blood flow will be recorded. Treatment decision will be made by the neurointensive care specialist based on standard care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD | Regional CBF values calculated with the investigational devices (CBMS) are within ranges described in literature, and dynamic changes of regional CBF are consistent to those values obtained with established methods CT perfusion and TCD. | Up to 28 days until probe removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety related to catheter insertion and monitoring | Safety related to catheter insertion and monitoring: local hematomas, infections, CSF drainage dysfunction in comparison with other standard intra-ventricular devices. | Until 7 days after probe removal |