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临床试验/NCT04490005
NCT04490005已完成不适用

Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil

University of Milano Bicocca14 个研究点 分布在 8 个国家目标入组 118 人开始时间: 2020年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
118
试验地点
14
主要终点
Correlation between abnormal Neurological Pupil index (NPi) and long-term outcome

研究概览

简要总结

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.

详细描述

Introduction Pupillary examination, and in particular pupillary light reactivity (PLR), is fundamental for intensive care unit (ICU) monitoring and follow-up of patients with acute brain injury (ABI), and has both diagnostic and prognostic values. Secondary cerebral insults, e.g. elevated intracranial pressure (ICP) may alter midbrain function and cause abnormalities in pupil size, symmetry and PLR. Sustained or newfound pupillary abnormalities are associated with a worse outcome, and indeed PLR is a robust validated predictor in several prognostic models, such as the CRASH (Corticosteroid Randomization after Significant Head Injury) and the IMPACT (International Mission for Prognosis and Analysis of Clinical Trials) scores. In current clinical practice however, pupillary examination is performed using a manual, hand-held light source (e.g. pen torch), implying that the evaluation of pupillary size and reactivity remains essentially based on a visual qualitative assessment. This traditional approach has several limitations, such as limited precision (especially in patients with small pupil size), significant intra- and inter-observer variability, differences in ambient light exposure between measurements, or the technique used to direct the stimulus (i.e. intensity, proximity, duration and orientation of the light source).

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, CA, 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. For this purpose, large multicenter studies are required. The Investigators recently conducted an international multicenter study that demonstrated the prognostic value of NPi in the setting of early prognostication of ABI following cardiac arrest. Here, the Investigators aim at evaluating the prognostic value of the NPi in patients with ABI following traumatic brain injury (TBI), aneurysmal subarachnoid hemorrhage (SAH) or intracerebral hemorrhage (ICH) at risk of secondary ICP elevation.

Research questions

The Investigators hypothesize that:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • ABI not admitted to the ICU.
  • Facial trauma not allowing pupils' evaluation.
  • Age < 18 years

结局指标

主要结局

Correlation between abnormal Neurological Pupil index (NPi) and long-term outcome

时间窗: 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.

次要结局

  • Correlation between intracranial hypertension and abnormal NPI values(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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