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Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil indEx

NCT04490005 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 118

Last updated 2023-01-25

No results posted yet for this 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 12-month of recruitment based on 60 patients/centre plus 6 months GOS-E follow-up.

Conditions

  • Acute Brain Injury
  • Pupillary Reflex Impaired

Interventions

OTHER

pupillometry

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

Sponsors & Collaborators

  • University of Lausanne

    collaborator OTHER

  • Université Libre de Bruxelles

    collaborator OTHER

  • University of Milano Bicocca

    lead OTHER

Principal Investigators

  • Giuseppe Citerio, MD, Prof · University of Milano Bicocca

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2022-04-02
Completion
2022-05-03

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Italy
  • Norway
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04490005 on ClinicalTrials.gov