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NCT04247321 Clinical Trial

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

Brain Injuries Clinical Trial

Official title:
Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure Monitoring in Neurocritical Care

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04247321
Other study ID # 19-008406
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date June 1, 2023

Study information
Verified date September 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Licox® Brain Tissue Oxygen Monitoring System
Invasive brain tissue oxygenation monitoring
• Near-infrared spectroscopy (NIRS)
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

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Correlation between changes in pressure reactivity index and Licox versus NIRS The pressure reactivity index (PRx) is derived using ICM+ software; the PRx is a correlation coefficient ranging from -1 to +1; PRx > 0 indicates poor autoregulation. We will investigate if PRx correlates with changes in rSO2 as measured by NIRS (if changes in autoregulation correspond with changes in oxygenation). 3 to 5 days of the monitoring duration
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