A Study to Compare Non-invasive Near-infrared Spectroscopy (NIRS) to Invasive Licox Intracranial Pressure Monitoring in Neurocritical Care
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-008406
NCT ID: NCT04247321
Sponsor Protocol Number: 19-008406
About this study
The purpose of this study is to assess the ability of Non-invasive near-infrared spectroscopy (NIRS) as compared to Licox to detect regional changes in brain tissue oxygenation, and to compare changes in management based on data derived from monitoring.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult patients 18 years or older.
- Patients with Glasgow coma scale score (GCS) ≤ 8
- Patients having neuroimaging concerning for ICP crises or have active ICP treatment may undergo non-invasive NIRS monitoring and invasive LICOX intraparenchymal brain tissue oxygen monitoring once study consent is obtained.
Exclusion Criteria:
- Patients with CNS infection.
- Patients with bleeding diathesis or thrombocytopenia < 50,000 platelets.
- Patients with subdural hematomas who have had surgical decompression and bone flap removal.
- Each patient will undergo 3 to 10 days of monitoring (depending on pathology; i.e., patients with poor-grade aneurysmal subarachnoid hemorrhage may undergo longer monitoring to assess for delayed cerebral ischemia during the time window of vasospasm risk).
- Pregnant individuals.
- Children.
- Prisoners.
- Institutionalized individuals.
- Others who are likely to be vulnerable.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available