Evaluation of the Correlation Between the 2 Pupillometry Indexes (QPI and NPI) in Cerebral Palsy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the correlation of the 2 existing NPI pupillometry index ans the IPQ in cerebral palsy patients
研究概览
简要总结
Pupillary examination, and in particular pupillary reactivity to light, is fundamental to the monitoring and follow-up in intensive care units of patients with acute brain injury. A pupillometric index combining different parameters of pupillary light reflex has been described as predictive of intracranial hypertension and the neurological outcome of the patient.
详细描述
Pupillary examination, and in particular pupillary reactivity to light, is fundamental for the monitoring and follow-up in intensive care units of patients with acute brain injury. Intracranial pressure monitoring and pupillometry measurement are thus part of the routine practice of intensive care unit management of brain injured patients. Furthermore, elevated intracranial pressure in brain injured patients admitted to the ICU is associated with a poor prognosis, and very high intracranial pressure is a life-threatening situation.
A pupillometry index combining different parameters of pupillary light reflex has been described as having predictive value of intracranial hypertension and neurological outcome of the patient: the "NPi". Another manufacturer IdMed, Marseille, France proposes an index: the QPI (Quantitative Pupillometry Index), based on a statistical classification of the amplitude of the light reflex.
The aim of this study is to show that :
- QPI is equivalent to NPI
- An abnormal value of the pupillometry indexes (NPI/QPI) is predictive of high intracranial pressure.
- An abnormal value of pupillometry indexes (NPI/QPI) is predictive of a poor neurological outcome at 6 months.
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
- 否
入选标准
- •Patients ≥ 18 years of age
- •Patients admitted for any brain injury: traumatic, intracranial hemorrhage, subarachnoid hemorrhage
- •Pupillometry available as a standard assessment tool.
- •Patient intubated/ventilated for neurological reasons for more than 12 hours
排除标准
- •Non-intensive care patients
- •Facial and or ocular trauma not allowing pupillometry evaluation
- •Patients admitted to the ICU with a life expectancy of < 24 hours
- •Protected persons (under guardianship, curators, pregnant or breastfeeding women, persons deprived of liberty, persons not subject to a psychiatric measure)
- •Patients not affiliated to a social security system
- •Patients who object to the use of their data for research purposes
结局指标
主要结局
To evaluate the correlation of the 2 existing NPI pupillometry index ans the IPQ in cerebral palsy patients
时间窗: at 7 days
The NPI and QPI value between 0 and 5
次要结局
- To assess the relationship between pupillometry indices (NPI/QPI) and intracranial hypertension(at 7 days)
- Describe the satisfaction of the caregivers on the use of these 2 pupillometry devices(at 1 year)
- To evaluate the contribution of the QPI and NPI indexes in predicting mortality and neurological outcome compared to existing scores (IMPACT, CRASH)(6 months)