A New Minimal-invasive Brain Tissue Probe Applying Near Infrared Spectroscopy

NeMoDevices

Status: Completed

Conditions: Spontaneous Subarachnoid Hemorrhage

Treatments: Device: NeMo Probe

Study type: Interventional

Funder types: Industry

Identifiers

NCT01801306

CIV-12-04-006261

Details and patient eligibility

About

To assess the feasibility of a new brain tissue probe for multi-parameter neuromonitoring (NeMo Probe) and the accuracy of measurement values.

To demonstrate the ability of the NeMo probe to detect changes in cerebral hemodynamics and oxygenation during cerebrovascular events monitored with established methods including brain tissue oxygenation tension and microdialysis

Enrollment: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females aged 18-75 years (inclusive)
• Patients with high-grade subarachnoid hemorrhage (WFNS 4-5)
• Decreased level of consciousness with the need for intracranial pressure monitoring
• Successful exclusion of the ruptured aneurysm with clipping or coiling
• Women of childbearing potential must have a negative serum pregnancy test
• Written informed consent obtained by a legal representative

Exclusion criteria

• Significant kidney and/or liver disease
• Any severe unstable concomitant condition or disease (e.g. cancer, coronary disease) or chronic condition (e.g. psychiatric disorder, chronic obstructive pulmonary disease Grade II, chronic heart failure > NYHA II)
• Cerebrospinal fluid infection or signs of meningoencephalitis
• Acute respiratory distress syndrome (ARDS), pulmonary edema
• Preexisting coagulation disorder
• Patients with current alcohol or drug abusus or dependence
• Patients with a history of hypersensitivity against indocyanine green or sodium iodine
• Patients with thyroid disease causing hyperthyroidism
• Breast-feeding women
• Patients committed to an institution based on official directive or court order

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

NeMoProbe

Other group

Description:

The NeMo System is used for intracranial pressure (ICP) and brain temperature monitoring, as well as the determination of the brain tissue oxygenation saturation (SbtO2) and cerebral blood flow. The sensors for NIRS are implemented into a conventional brain tissue probe for ICP monitoring (NeMo Probe).

Treatment:

Device: NeMo Probe