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NCT04490005 · ClinicalTrials.gov registry record
Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil indEx
A clinical trial, sponsored by University of Milano Bicocca.
- Completed
- Registry status
- 118
- Enrollment target
NCT04490005: Completed study, sponsored by University of Milano Bicocca.
NCT04490005 is a clinical trial that has completed, run by University of Milano Bicocca. The registered enrollment target is 118 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04490005 has completed, sponsored by University of Milano Bicocca.
- COMPLETED
- Registry status
- 118 participants
- Enrollment target
Study Summary
The use of quantitative, automated, infrared technology for pupillary examination has long been used in ophthalmology and anesthesiology research. Its interest in neurocritical care has progressively grown, in parallel with the advancements in device technology. In this regard, the use of the noninvasive NPi®-200 pupillometer (Neuroptics, Laguna Hills, California, USA) allows the measurement of a series of dynamic pupillary variables (including the percentage pupillary constriction, latency, constriction velocity, and dilation velocity), which can be integrated into an algorithm, to compute the Neurological Pupil index (NPi). The NPi is a proprietary scalar index with values between 0 and 5 (with a 0.1 decimal precision), an NPi value \< 3 indicating an abnormal pupillary reactivity. Importantly, the NPi is not influenced by sedation-analgesia, at the doses used in neurocritical care practice, and by mild hypothermia. Preliminary single-center data recently demonstrated that abnormal NPi is associated with worse outcome in patients with traumatic and hemorrhagic ABI, and can be a useful adjunct for ICP monitoring and therapy. There is currently a great need for quantitative tools to predict early prognostication in ABI patients, and the NPi appears of potential great value. We hypothesize that: 1. Abnormal NPi (defined as NPi \<3) are strongly predictive of poor GOS-E (1-4) at 6 months after the acute event. 2. NPi=0 is strongly predictive of mortality (GOS 1). 3. Abnormal NPi is predictive of a higher ICP 20 index (number of end-hourly measures of ICP \>20 mm Hg divided by the total number of measurements, multiplied by 100) and a greater burden of interventions needed to control ICP (measured by the Therapy Intensity Level scale for ICP management, Therapy Intensity Level (TIL) 4). Methods This international multicentre prospective observational study aims to recruit \>400 patients admitted to intensive care units. Duration of the study 18 months, including 1
Primary Outcome
To evaluate the association between abnormal Neurological Pupil index (NPi) and long-term outcome (6-month mortality and neurological recovery, measured with the extended Glasgow Outcome Score, GOS-E) in patients with ABI.
Interventions
- OTHER pupillometry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2020-11-02 |
| Est. Completion | 2022-05-03 |
What the finished NCT04490005 record still lists
NCT04490005 is an observational study that tracks outcomes without assigning an intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which pupillometry is the first listed.
NCT04490005 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04490005 about?
NCT04490005 is a clinical study titled "Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil indEx". The use of quantitative, automated, infrared technology for pupillary examination has long been used in ophthalmology and anesthesiology research. Its interest in neurocritical care has progressively grown, in parallel with the advancements in device technology. In this regard, the use of the noninv...
What is the current status of trial NCT04490005?
This trial is currently completed. The enrollment target is 118 participants. The study started on 2020-11-02. Estimated completion is 2022-05-03.
What interventions are being tested in trial NCT04490005?
The interventions under investigation include: pupillometry (OTHER).
Who is sponsoring clinical trial NCT04490005?
This trial is sponsored by University of Milano Bicocca, which has 3 total clinical trials registered on ClinicalTrials.gov.
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