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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Brain Injuries

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

External Links

•   Mayo Clinic Clinical Trials