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

Carag

Status

Active, not recruiting

Conditions

Brain Injuries

Treatments

Device: Placement of the CBMS Probe

Study type

Interventional

Funder types

Industry

Identifiers

NCT03249220

2015.5703

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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