Evaluation and Application of Experimental Indices for the Study of Potential Prognostic Factors in Patients With Acute Neurological Injury, Using Low-frequency Sampled Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Glasgow Outcome Scale - Extended (GOSE)
研究概览
简要总结
The pressure reactivity index (PRx) has emerged as a surrogate method for the continuous bedside estimation of global cerebral autoregulation and a significant predictor of unfavorable outcomes. However, calculations require continuous, high-resolution monitoring and are currently limited to specialized ICUs with dedicated software. To overcome this problem, new indices calculated using one-minute average data, instead of 10-second average data as performed by the PRx, have been proposed.
The study aims to test new physiological indices appropriately modified to adapt to the scarcity of output data generated by standard hospital systems (frequency ~0.0033 Hz, approximately a 5-minute period) and to evaluate their association with outcome measures.
详细描述
Data preparation and index calculations were performed using an in-house algorithm.
Data extracted and processed with the algorithm:
Ultra-low pressure reactivity index (UL-PRx), Intracranial pressure (ICP), Cerebral perfusion pressure (CPP), Arterial blood pressure (ABP), heart rate (HR), respiratory rate (RR), temperature, end-tidal CO2 (EtCO2), saturation (SpO2).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of acute neurological injury requiring intracranial pressure (ICP) monitoring.
- •Availability of continuous intensive care monitoring of physiological data.
排除标准
- •Patients with less than 8 hours of physiological data monitoring.
结局指标
主要结局
Glasgow Outcome Scale - Extended (GOSE)
时间窗: 12-months
The global functional outcome at 12 months assessed by Glasgow Outcome Scale-Extended (GOS-E), dichotomized into favorable (a score of 5-6 defines a score of 5 to 8, Moderate Disability) and unfavorable (a score of 1 to 4, Dead is characterized by a score of 1).
mortality
时间窗: 12-months
The binary outcome of mortality (dead vs alive) during hospitalization and at 12-months
次要结局
未报告次要终点
研究者
Paolo GRITTI
Principal Investigator
Papa Giovanni XXIII Hospital