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

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ClinicalTrials.gov Identifier: NCT01920347
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
C. Storm, 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.

Condition or disease
Hypoxic Encephalopathy

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Pilot Trial to Evaluate the NeurOptics Pupillometer and Clinical Examination of the Pupillary Reflex After Cardiac Arrest
Study Start Date : May 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Group/Cohort
Neurological Pupil index
The NPi will be measured during treatment



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Survivors after cardiac arrest
Criteria

Inclusion Criteria:

  • all survivors after cardiac arrest

Exclusion Criteria:

  • underlying disease limiting the pupillary reflex

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920347


Locations
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Germany
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Charité Universitätsmedizin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Christian Storm, MD Charite University, Berlin, Germany

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Responsible Party: C. Storm, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01920347     History of Changes
Other Study ID Numbers: 112823
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015

Keywords provided by C. Storm, Charite University, Berlin, Germany:
hypoxic encephalopathy
cardiac arrest
outcome
pupillary reflex

Additional relevant MeSH terms:
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Brain Diseases
Hypoxia, Brain
Central Nervous System Diseases
Nervous System Diseases