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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01920347
Acronym
NPI-ON-ICU
Enrollment
100
Registered
2013-08-12
Start date
2013-05-31
Completion date
2015-02-28
Last updated
2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic Encephalopathy

Keywords

hypoxic encephalopathy, cardiac arrest, outcome, pupillary reflex

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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* all survivors after cardiac arrest

Exclusion criteria

* underlying disease limiting the pupillary reflex

Design outcomes

Primary

MeasureTime frameDescription
Neurological Pupil index (NPi) on a scale from 0-5up to 7 daysNPi values by the device on a scale by 0-5; \>3 indicates normal reaction; \<3 abnormal.

Secondary

MeasureTime frameDescription
Cerebral performance category (CPC)Patients will be followed for the duration of hospital stay, an expected average of 2 weekscerebral performance category; 1-2 good outcome; 3-5 poor outcome

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026