The Neurological Pupil Index (NPi) on Intensive Care Unit... | NCT01920347

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

NCT01920347

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Feb 18, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Hypoxic Encephalopathy

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

May 27, 2013

First Submission Date that Met QC Criteria

Aug 9, 2013

First Posted Date

Aug 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2015

Last Update Posted Date

Feb 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

C. Storm, Principal Investigator, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Neurological Pupil index		The NPi will be measured during treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Cerebral performance category (CPC)	cerebral performance category; 1-2 good outcome; 3-5 poor outcome	Patients will be followed for the duration of hospital stay, an expected average of 2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all survivors after cardiac arrest

Exclusion Criteria:

underlying disease limiting the pupillary reflex

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Survivors after cardiac arrest

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Storm, MD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité Universitätsmedizin Berlin		Berlin		13353	Germany
Charité Universitätsmedizin

Condition Browse Module

MeSH Terms

ID	Term
D002534	Hypoxia, Brain
D006323	Heart Arrest

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000860	Hypoxia

Browse Leaves

Not provided

Browse Branches

Not provided