Clinical Trial: The Neurological Pupil Index (NPi) on Intensive Care Unit (ICU) Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prospective Pilot Trial to Evaluate the NeurOptics Pupillometer and Clinical Examination of the Pupillary Reflex After Cardiac Arrest

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 Summary: 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.
Sponsor: Charite University, Berlin, Germany

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Cerebral performance category (CPC) [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: Charite University, Berlin, Germany

Dates:
Date Received: May 27, 2013
Date Started: May 2013
Date Completion:
Last Updated: February 16, 2015
Last Verified: February 2015