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

NCT ID: NCT03249220

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2027-09-30

Brief Summary

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

Brain Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

CBMS

Group Type: EXPERIMENTAL

Placement of the CBMS Probe

Intervention Type: DEVICE

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.

Interventions

Placement of the CBMS Probe

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carag AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Werner Z'Graggen

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

Inselspital Bern

Bern, Canton of Bern, Switzerland

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

2015.5703

Identifier Type: -

Identifier Source: org_study_id