NCT01920347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

1.8 years

First QC Date

May 27, 2013

Last Update Submit

February 16, 2015

Conditions

Hypoxic Encephalopathy

Keywords

hypoxic encephalopathycardiac arrestoutcomepupillary reflex

Outcome Measures

Primary Outcomes (1)

  • Neurological Pupil index (NPi) on a scale from 0-5

    NPi values by the device on a scale by 0-5; \>3 indicates normal reaction; \<3 abnormal.

    up to 7 days

Secondary Outcomes (1)

  • Cerebral performance category (CPC)

    Patients will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (1)

Neurological Pupil index

The NPi will be measured during treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Survivors after cardiac arrest

You may qualify if:

  • all survivors after cardiac arrest

You may not qualify if:

  • underlying disease limiting the pupillary reflex

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Charité Universitätsmedizin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Hypoxia, BrainHeart Arrest

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Christian Storm, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2013

First Posted

August 12, 2013

Study Start

May 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

DE(2)