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

NCT ID: NCT01920347

Last Updated: 2015-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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.

Conditions

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Hypoxic Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neurological Pupil index

The NPi will be measured during treatment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* all survivors after cardiac arrest

Exclusion Criteria

* underlying disease limiting the pupillary reflex
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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C. Storm

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Storm, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Charité Universitätsmedizin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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112823

Identifier Type: -

Identifier Source: org_study_id

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