Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure

Mayo Clinic

Status: Withdrawn

Conditions: Brain Injuries

Treatments: Device: Near-infrared spectroscopy (NIRS); Device: Licox® Brain Tissue Oxygen Monitoring System

Study type: Interventional

Funder types: Other

Identifiers

NCT04247321

19-008406

Details and patient eligibility

About

Researchers are trying to assess how accurately and safely NIRS non-invasive monitoring can detect changes in intracranial pressure to determine if this noninvasive device can be used instead of invasive monitoring with Licox in the future.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Subjects with acute brain injury who are age ≥ 18
• Glasgow coma scale score (GCS) ≤ 8
• Neuroimaging concerning for ICP crises, or have active ICP treatment
• Have Licox Brain Tissue Oxygen monitor placed as standard of care treatment

Exclusion:

• CNS infection
• Bleeding diathesis or thrombocytopenia < 50,000 platelets
• Subjects with subdural hematomas who have had surgical decompression and bone flap removal

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Subjects with acute brain injury

Experimental group

Description:

Subjects requiring placement of a Licox Brain Tissue Oxygen device for their clinical care will also have Near-infrared spectroscopy (NIRS) monitoring system placed

Treatment:

Device: Near-infrared spectroscopy (NIRS)

Device: Licox® Brain Tissue Oxygen Monitoring System