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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

Tracking Information
First Submitted Date May 27, 2013
First Posted Date August 12, 2013
Last Update Posted Date February 18, 2015
Study Start Date May 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 9, 2013)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01920347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 9, 2013)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Neurological Pupil Index (NPi) on Intensive Care Unit (ICU) Trial
Official Title Prospective Pilot Trial to Evaluate the NeurOptics Pupillometer and Clinical Examination of the Pupillary Reflex After Cardiac Arrest
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Survivors after cardiac arrest
Condition Hypoxic Encephalopathy
Intervention Not Provided
Study Groups/Cohorts Neurological Pupil index
The NPi will be measured during treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: August 9, 2013)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • all survivors after cardiac arrest

Exclusion Criteria:

  • underlying disease limiting the pupillary reflex
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01920347
Other Study ID Numbers 112823
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party C. Storm, Charite University, Berlin, Germany
Study Sponsor Charite University, Berlin, Germany
Collaborators Not Provided
Investigators
Principal Investigator: Christian Storm, MD Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date February 2015