The Neurological Pupil Index (NPi) on Intensive Care Unit (ICU) Trial
- Conditions
- Hypoxic Encephalopathy
- Registration Number
- NCT01920347
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- all survivors after cardiac arrest
- underlying disease limiting the pupillary reflex
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Neurological Pupil index (NPi) on a scale from 0-5 up to 7 days NPi values by the device on a scale by 0-5; \>3 indicates normal reaction; \<3 abnormal.
- Secondary Outcome Measures
Name Time Method Cerebral performance category (CPC) Patients will be followed for the duration of hospital stay, an expected average of 2 weeks cerebral performance category; 1-2 good outcome; 3-5 poor outcome
Trial Locations
- Locations (2)
Charité Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Charité Universitätsmedizin
🇩🇪Berlin, Germany