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Completed

NCT Number: NCT01920347

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

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.

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Key information

Conditions

Hypoxic Encephalopathy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Heart Arrest Heart Diseases Hypoxia Hypoxia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité Universitätsmedizin, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all survivors after cardiac arrest

Exclusion criteria

  • underlying disease limiting the pupillary reflex

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: NPI-ON-ICU

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 12, 2013
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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