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Clinical Trials/NCT01920347
NCT01920347CompletedNot Applicable

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

Charite University, Berlin, Germany2 sites in 1 country100 target enrollmentStarted: May 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
Neurological Pupil index (NPi) on a scale from 0-5

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

C. Storm

Principal Investigator

Charite University, Berlin, Germany

Study Sites (2)

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