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

NCT04247321 | Withdrawn FDA Device

• 1 other identifier: 19-008406
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (1)

• Correlation between changes in Licox and NIRS oxygenation measurements

  Licox measures oxygenation in terms of partial pressure (PtO2) and NIRS measures it in terms of saturation (rSO2). The changes in PtO2 versus the changes in rSO2 will be compared for equivalence.

  3 to 5 days of the monitoring duration

Secondary Outcomes (1)

• Correlation between changes in pressure reactivity index and Licox versus NIRS

  3 to 5 days of the monitoring duration

Study Arms (1)

Subjects with acute brain injury

EXPERIMENTAL

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

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

Interventions

Licox® Brain Tissue Oxygen Monitoring System DEVICE

Invasive brain tissue oxygenation monitoring

Subjects with acute brain injury

Near-infrared spectroscopy (NIRS) DEVICE

Non-invasive approach to monitoring brain tissue oxygenation which uses two wavelengths of near infrared light and takes measurements of the ratio of oxyhemoglobin to total hemoglobin

Subjects with acute brain injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Injuries

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Alejandro A Rabinstein

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: September 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)