Identification of Patients at Risk of Undesired Obstruction in External Ventricular Drain: Development of a Score Based on the Extent of Intra-ventricular Hemorrhage. A Single-Center, Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Assessment of the predictive value of IVH severity for EVD obstruction
研究概览
简要总结
Acute obstructive hydrocephalus often complicates intraventricular hemorrhage (IVH). The insertion of an external ventricular drain (EVD) is typically necessary in order to alleviate intracranial pressure by draining excess fluid. However, dysfunction of the EVD whether due to malposition or obstruction, can exacerbate hydrocephalus in an already compromised brain. EVD dysfunction must therefore be promptly detected and treated.
Consequently, identifying high-risk patients and closely monitoring them is imperative. While IVH is known to increase the risk of obstruction in the natural cerebrospinal fluid outflow tract, its association with ventricular drain obstruction remains unproven.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Assessment of the predictive value of IVH severity for EVD obstruction
时间窗: From EVD insertion to removal up to 100 days.
HIV severity will be estimated using an adaptation of the existing Graeb's score: the Graeb-EVD score. EVD obstruction is defined by an abnormally reduced drainage flow, requiring intervention to restore normal function (cases of EVD malposition will be excluded).The predictive performance of the Graeb-EVD score will be evaluated by the area under the receiver operating characteristic curve (AUC-ROC). The AUC-ROC ranges from 0 to 1. The predictive ability will be considered acceptable if associated with an AUC-ROC greater than 0.70, good if greater than 0.80, and excellent if greater than 0.90.
次要结局
- To evaluate the effect of unplanned EVD obstruction on the need for internalization of the ventricular shunt (ventriculoperitoneal or ventriculoatrial shunt).(From EVD insertion to ICU discharge up to 6 months.)
- Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for a new EVD insertion because of obstruction.(From EVD insertion to hospital discharge up to 12 months.)
- To evaluate the effect of unplanned EVD obstruction on the functional outcome assessed on the day of hospital discharge and at 3±1 months.(From EVD insertion to month 3 (± 1 month) after IVH.)
- To evaluate whether the Graeb-EVD, original Graeb, and modified Graeb scores are useful in predicting an EVD-related neuromeningeal infection.(From EVD insertion to ICU discharge up to 6 months.)
- Comparison of the performance of the Graeb-EVD score with that of the original Graeb score and the modified Graeb scores for the prediction of the occurrence of at least one episode of EVD obstruction.(From EVD insertion to removal up to 100 days.)
- Performance of IVH severity as a predictor of the occurrence of at least one episode of EVD obstruction within the first seven days(From EVD insertion to day 7.)
- To evaluate whether the Graeb-EVD, original Graeb, and modified Graeb scores are useful in predicting an unfavorable functional outcome on the day of hospital discharge and at 3±1 months.(From EVD insertion to hospital discharge up to 12 months)
- To evaluate if HIV is an independent risk factor for the occurrence of at least one episode of unplanned EVD obstruction.(From EVD insertion to removal up to 100 days.)
- Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for cerebrospinal fluid internal shunt.(From EVD insertion to hospital discharge up to 12 months.)