Back to resultsNon-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure
Primary Purpose
Brain Injuries
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Licox® Brain Tissue Oxygen Monitoring System
Near-infrared spectroscopy (NIRS)
Sponsored by
About this trial
This is an interventional device feasibility trial for Brain Injuries
Eligibility 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with acute brain injury
Arm 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04247321
Brief Title
Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure
Official Title
Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure Monitoring in Neurocritical Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
• Withdrawn: Study halted prematurely, prior to enrollment of first participant
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with acute brain injury
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Licox® Brain Tissue Oxygen Monitoring System
Intervention Description
Invasive brain tissue oxygenation monitoring
Intervention Type
Device
Intervention Name(s)
Near-infrared spectroscopy (NIRS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Correlation between changes in Licox and NIRS oxygenation measurements
Description
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.
Time Frame
3 to 5 days of the monitoring duration
Secondary Outcome Measure Information:
Title
Correlation between changes in pressure reactivity index and Licox versus NIRS
Description
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).
Time Frame
3 to 5 days of the monitoring duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro A Rabinstein
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure
We'll reach out to this number within 24 hrs