Observational studyThe Lancet. Neurology2023
The Neurological Pupil index for outcome prognostication in people with acute brain injury (ORANGE): a prospective, observational, multicentre cohort study.
Observational study in The Lancet. Neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 49 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil
Constructing a Model of Pupillary Parameters in Predicting Delirium Among Critically Ill Patients in the Intensive Unit
Who cites it
49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 84 citations in OpenAlex.
- Prognostic value of automated pupillometry in traumatic brain injury: a systematic review and meta-analysis.Neurosurgical review · 2026Pooled it
- Neurological Monitoring and Management for Adult Extracorporeal Membrane Oxygenation Patients: Extracorporeal Life Support Organization Consensus Guidelines.ASAIO journal (American Society for Artificial Internal Organs : 1992) · 2024Guideline
- Unreactive EEG Background Is Associated With Unfavorable Outcome in Patients With Disorders of Consciousness of Various Etiologies: An Adult Cohort Study.European journal of neurology · 2025Trial
- Comparison of two automated pupillometry indices in patients with acute brain injury: the prospective multicentre LYNX cohort study.Critical care (London, England) · 2026Observational
- Integrating Brain Imaging Volumetrics and Quantitative Pupillometry for Predicting Neurologic Deterioration after Large Hemispheric Stroke.Neurocritical care · 2026Article
- How we use the neurological pupil index (NPi).Critical care (London, England) · 2026Article
- Automated pupillometry for the prediction of neurologic outcomes in children requiring extracorporeal membrane oxygenation (ECMO).European journal of pediatrics · 2026Observational
- Exploring the relative stability of automated infrared pupillometry parameters under sedative and analgesic exposure after cardiac surgery.BMC anesthesiology · 2026Observational
- Editor letter for Sanna Holmskär "Is quantitative pupillometry affected by ambient light? A prospective crossover study. J Clin Monit Comput, 2025".Journal of clinical monitoring and computing · 2026Article
- Quantitative pupillometry as a sensitive tool for detecting hydrocephalus-related physiologic burden after aSAH: a prospective feasibility study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Article
- Persistence of NPi differential predicts outcome at intensive care unit discharge: a single-center retrospective analysis.Journal of anesthesia, analgesia and critical care · 2026Article
- Defying An Ominous Sign: Complete Neurological Recovery after Bilateral Fixed Dilated Pupils in Hypercapnic Respiratory Failure.European journal of case reports in internal medicine · 2026Article
- A Bedside Coagulation-Platelet Tipping Point for Mortality in Nontraumatic Subarachnoid Hemorrhage.Journal of multidisciplinary healthcare · 2026Article
- Observational
- The association between neurologic pupillary index (NPi) and functional outcomes in critically ill children.BMC pediatrics · 2025Observational
- Quantitative pupillometry as a sensitive tool for detecting tumor-related mass effect in the posterior fossa: a prospective feasibility study comparing metastatic versus skull base lesions.Journal of neuro-oncology · 2025Article
- Risk factor analysis of long-term outcomes in patients with large intracerebral and intraventricular hemorrhage treated primarily with combined external ventricular drainage and intraventricular thrombolysis.European journal of medical research · 2025Article
- Prolonged P14 latency predicts mortality in deep sedation: implications for neuroprotective sedation strategies-author's reply.Intensive care medicine · 2025Article
- Dangerous Alarming Diameter Assessment (DADA Index) in Which the Ratio of Iris Surface/Pupil Surface Size Is More Reliable than Pupil Diameter Measurement in Comatose Patients After Subarachnoid Haemorrhage: An Experimental Rabbit Model.Diagnostics (Basel, Switzerland) · 2025Article
- Integrating Brain Imaging Volumetrics and Quantitative Pupillometry for Predicting Neurologic Deterioration after Large Hemispheric Stroke.Research square · 2025Article
Corrections and comments
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Authors and funding
20 authors at 14 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundImproving the prognostication of acute brain injury is a key element of critical care. Standard assessment includes pupillary light reactivity testing with a hand-held light source, but findings are interpreted subjectively; automated pupillometry might be more precise and reproducible. We aimed to assess the association of the Neurological Pupil index (NPi)-a quantitative measure of pupillary reactivity computed by automated pupillometry-with outcomes of patients with severe non-anoxic acute brain injury.
methodsORANGE is a multicentre, prospective, observational cohort study at 13 hospitals in eight countries in Europe and North America. Patients admitted to the intensive care unit after traumatic brain injury, aneurysmal subarachnoid haemorrhage, or intracerebral haemorrhage were eligible for the study. Patients underwent automated infrared pupillometry assessment every 4 h during the first 7 days after admission to compute NPi, with values ranging from 0 to 5 (with abnormal NPi being <3). The co-primary outcomes of the study were neurological outcome (assessed with the extended Glasgow Outcome Scale [GOSE]) and mortality at 6 months. We used logistic regression to model the association between NPi and poor neurological outcome (GOSE ≤4) at 6 months and Cox regression to model the relation of NPi with 6-month mortality. This study is registered with ClinicalTrials.gov, NCT04490005.
findingsBetween Nov 1, 2020, and May 3, 2022, 514 patients (224 with traumatic brain injury, 139 with aneurysmal subarachnoid haemorrhage, and 151 with intracerebral haemorrhage) were enrolled. The median age of patients was 61 years (IQR 46-71), and the median Glasgow Coma Scale score on admission was 8 (5-11). 40 071 NPi measurements were taken (median 40 per patient [20-50]). The 6-month outcome was assessed in 497 (97%) patients, of whom 160 (32%) patients died, and 241 (47%) patients had at least one recording of abnormal NPi, which was associated with poor neurological outcome (for each 10% increase in the frequency of abnormal NPi, adjusted odds ratio 1·42 [95% CI 1·27-1·64]; p<0·0001) and in-hospital mortality (adjusted hazard ratio 5·58 [95% CI 3·92-7·95]; p<0·0001).
interpretationNPi has clinically and statistically significant prognostic value for neurological outcome and mortality after acute brain injury. Simple, automatic, repeat automated pupillometry assessment could improve the continuous monitoring of disease progression and the dynamics of outcome prediction at the bedside.
fundingNeurOptics.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.