Prospective Pilot Trial to Evaluate the NeurOptics Pupillometer and Clinical Examination of the Pupillary Reflex After Cardiac Arrest
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoxic Encephalopathy
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Neurological Pupil index (NPi) on a scale from 0-5
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The trial will evaluate the use of the "Neurological Pupil index" NPi, measured with the digital pupillometer (NeurOptics) compared to clinical examination for better reliability. The investigators hypothesize that digital evaluation will offer a higher sensitivity/ specificity compared to clinical examination.
Detailed Description
Absent pupillary reaction after cardiac arrest might indicate a severe hypoxic encephalopathy. Because the examination of the pupillary reaction is easy it is part of the clinical routine but due to the different medication and the dynamic process of reperfusion injury to the brain a clinical evaluation might be not precise enough. The NPi has been shown to be superior to clinical evaluation in different settings but without regard towards cardiac arrest survivors. The Pupillometer is a hand-held, cordless, and simple to use device which removes subjectivity in the measurement of pupil size and the pupillary light reflex.
Investigators
C. Storm
Principal Investigator
Charite University, Berlin, Germany
Eligibility Criteria
Inclusion Criteria
- •all survivors after cardiac arrest
Exclusion Criteria
- •underlying disease limiting the pupillary reflex
Outcomes
Primary Outcomes
Neurological Pupil index (NPi) on a scale from 0-5
Time Frame: up to 7 days
NPi values by the device on a scale by 0-5; \>3 indicates normal reaction; \<3 abnormal.
Secondary Outcomes
- Cerebral performance category (CPC)(Patients will be followed for the duration of hospital stay, an expected average of 2 weeks)