Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil indEx (ORANGE)
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|ClinicalTrials.gov Identifier: NCT04490005|
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : March 1, 2021
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:
- Abnormal NPi (defined as NPi <3) are strongly predictive of poor GOS-E (1-4) at 6 months after the acute event.
- NPi=0 is strongly predictive of mortality (GOS 1).
- 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.
|Condition or disease||Intervention/treatment|
|Acute Brain Injury Pupillary Reflex Impaired||Other: pupillometry|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||420 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil|
|Actual Study Start Date :||November 2, 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2022|
Acute brain injury
Intensive care unit (ICU) admission after ABI, including traumatic brain injury (TBI), aneurysmal subarachnoid haemorrhage (SAH) and intracerebral haemorrhage (ICH)
• Age 18 years old.
evaluation of pupillary reflex by using the Neuroptics Pupillometer every 4 hours during ICU stay
- Correlation between abnormal Neurological Pupil index (NPi) and long-term outcome [ Time Frame: 6 months ]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.
- Correlation between intracranial hypertension and abnormal NPI values [ Time Frame: 6 months ]The secondary aim, in patients with ICP monitoring, is to evaluate the relationship of abnormal NPi and intracranial hypertension in order to prognosticate a poor neurological outcome (Glasgow Outcome Scale-Extended)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04490005
|Contact: Giuseppe Citerio, MD, Prof.||+39 039 233 email@example.com|
|Contact: Silvia Mori, Mrs||+39 firstname.lastname@example.org|
|United States, California|
|Department of Neurology, University of California||Recruiting|
|San Francisco, California, United States, 94110|
|Contact: Claude J Hemphill, MD|
|Contact: Dominica Randazzo, Mrs Dominica.Randazzo@ucsf.edu|
|Parnassus Hospital UCSF||Not yet recruiting|
|San Francisco, California, United States, 94143|
|Contact: Wade Smith Wade.Smith@ucsf.edu|
|United States, Maryland|
|John Hopkins||Not yet recruiting|
|Baltimore, Maryland, United States, 21218|
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|United States, Washington|
|Harborview Medical Center||Not yet recruiting|
|Seattle, Washington, United States, 98104|
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|Erasme Hospital, Université Libre de Bruxelles||Not yet recruiting|
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|Department Anesthesia and Critical Care, University Hospital||Not yet recruiting|
|Contact: Pierre Bouzat PBouzat@chu-grenoble.fr|
|Universitätsklinikum||Not yet recruiting|
|Contact: Stefan Schwab, Prof Stefan.Schwab@uk-erlangen.de|
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|Spedali Civili||Not yet recruiting|
|Brescia, BS, Italy, 25121|
|Contact: Frank A. Rasulo, Prof email@example.com|
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|ASST-MONZA San Gerardo Hospital||Recruiting|
|Monza, MB, Italy, 20900|
|Contact: Giuseppe Citerio, MD|
|Contact: Francesca Elli, PhD email@example.com|
|Policlinico Gemelli||Not yet recruiting|
|Roma, RM, Italy, 00168|
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|Oslo Universitary Hospital||Not yet recruiting|
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|Ramón Y Cajal University Hospital||Not yet recruiting|
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|Hospital Clinic Universitari de València, University of Valencia||Not yet recruiting|
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|Centre Hospitalier Universitaire Vaudois (CHUV), University Hospital and University of Lausanne||Not yet recruiting|
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|Principal Investigator:||Giuseppe Citerio, MD, Prof||University of Milano Bicocca|