CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 118 enrolled
Drug / intervention
pupillometryother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04490005
NCT04490005N/ACompleted

Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil

University of Milano Bicocca·observational·Posted Jul 28, 2020·Updated Jan 25, 2023

In Brief

An observational study evaluating pupillometry for Acute Brain Injury and Pupillary Reflex Impaired. Completed, enrolled 118 participants across 14 sites in 8 countries.

Detailed 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 12-month of recruitment based on 60 patients/centre plus 6 months GOS-E follow-up.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Germany, Italy, Norway, Spain, Switzerland, United States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 28, 2020
Enrollment StartNov 2, 2020
Primary CompletionApr 2, 2022
Study CompletionMay 3, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.9 years ago

Interventions

pupillometryother

evaluation of pupillary reflex by using the Neuroptics Pupillometer every 4 hours during ICU stay