Hypoxic EncephalopathyNPI-ON-ICUNCT01920347
The Neurological Pupil Index (NPi) on Intensive Care Unit (ICU) Trial
An observational study of Hypoxic Encephalopathy, run by Charite University, Berlin, Germany at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxic Encephalopathy
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- May 2013to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Survivors after cardiac arrest
Who may be able to join
- all survivors after cardiac arrest
Who cannot join
- underlying disease limiting the pupillary reflex
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité Universitätsmedizin Berlin
Berlin, 13353
Charité Universitätsmedizin
Berlin, 13353
About this study
Official title: Prospective Pilot Trial to Evaluate the NeurOptics Pupillometer and Clinical Examination of the Pupillary Reflex After Cardiac Arrest
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.
Read the 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.
- Conditions
- Hypoxic Encephalopathy
- Keywords
- hypoxic encephalopathy, cardiac arrest, outcome, pupillary reflex
- Medical subject headings
- Hypoxia, Brain, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neurological Pupil index | The NPi will be measured during treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 7 days
Secondary outcomes (1)
Cerebral performance category (CPC)
cerebral performance category; 1-2 good outcome; 3-5 poor outcome
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C. Storm, Charite University, Berlin, Germany
- Investigators
- Christian Storm, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920347
- Sponsor's protocol ID
- 112823
- Acronym
- NPI-ON-ICU
- Status last verified
- Feb 2015
- First submitted
- 27 May 2013
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Trial to Evaluate the NeurOptics Pupillometer and Clinical Examination of the Pupillary Reflex After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT01920347
- Acronym / sponsor ID
- NPI-ON-ICU / 112823
- Conditions
- Hypoxic Encephalopathy
- Keywords
- hypoxic encephalopathy, cardiac arrest, outcome, pupillary reflex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurological Pupil index | – | –The NPi will be measured during treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Survivors after cardiac arrest
Key inclusion criteria (1 listed)
- all survivors after cardiac arrest
Key exclusion criteria (1 listed)
- underlying disease limiting the pupillary reflex
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Cerebral performance category (CPC)
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Storm, MD principal investigator
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic Encephalopathy, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological Pupil index (NPi) on a scale from 0-5 (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.