Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil indEx
Completed
Conditions studied: Acute Brain Injury, Pupillary Reflex Impaired
In brief
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.
Key facts
- Study ID
- NCT04490005
- Run by
- University of Milano Bicocca
- People needed
- 118
- Starts
- 2020-11-02
- Expected to finish
- 2022-05-03
- Last updated by the study team
- 2023-01-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Intensive care unit (ICU) admission after ABI, including traumatic brain injury (TBI), aneurysmal subarachnoid haemorrhage (SAH) and intracerebral haemorrhage (ICH)
- Age > 18 years old.
- Pupillometry available as standard evaluation tool.
You may not qualify if…
- ABI not admitted to the ICU.
- Facial trauma not allowing pupils' evaluation.
- Age < 18 years
Where it is running
- Department of Neurology, University of California — San Francisco, California, United States
- Parnassus Hospital UCSF — San Francisco, California, United States
- John Hopkins — Baltimore, Maryland, United States
- Harborview Medical Center — Seattle, Washington, United States
- Erasme Hospital, Université Libre de Bruxelles — Brussels, Belgium
- Department Anesthesia and Critical Care, University Hospital — Grenoble, France
- Universitätsklinikum — Erlangen, Germany
- Spedali Civili — Brescia, BS, Italy
- ASST-MONZA San Gerardo Hospital — Monza, MB, Italy
- Policlinico Gemelli — Roma, RM, Italy
- Oslo Universitary Hospital — Oslo, Norway
- Ramón Y Cajal University Hospital — Madrid, Spain
- Hospital Clinic Universitari de València, University of Valencia — Valencia, Spain
- Centre Hospitalier Universitaire Vaudois (CHUV), University Hospital and University of Lausanne — Lausanne, Switzerland
Full record on ClinicalTrials.gov
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