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

Hypoxic Encephalopathy Clinical Trial

— NPI-ON-ICU  

Official title:

Prospective Pilot Trial to Evaluate the NeurOptics Pupillometer and Clinical Examination of the Pupillary Reflex After Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920347
• Other study ID #: 112823
• Status: Completed
• Phase: N/A
• First received: May 27, 2013
• Last updated: February 16, 2015
• Start date: May 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all survivors after cardiac arrest

Exclusion Criteria:

• underlying disease limiting the pupillary reflex

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Diseases
• Hypoxia, Brain
• Hypoxic Encephalopathy

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin	Berlin
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No