Brain Skull Deformation as a Non-invasive Intracranial Pressure (ICP) Measure: Comparison Between Invasive and Noninvasive Methods.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Comparison between ICP morphology between a non invasive (Brain4care [B4c]) and a invasive (intraventricular) method
研究概览
简要总结
Background: Although placement of an intra-cerebral catheter remains the gold standard method for measuring intracranial pressure (ICP), there are several limitations to the method. Objectives: The main objective of this study was to compare the correlation and the agreement of the wave morphology between the ICP (standard ICP monitoring) and a new nICP monitor in patients admitted with stroke. Our secondary objective was to estimate the accuracy of four non-invasive methods to assess intracranial hypertension. Methods: We prospectively collected data of adults admitted to an intensive care unit (ICU) with subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH) or ischemic stroke (IS) in whom invasive ICP monitoring placed. Measures had been simultaneously collected from the following non-invasive indices: optic nerve sheath diameter (ONSD), pulsatility index (PI) using transcranial Doppler (TCD), a 5-point visual scale designed for Computed Tomography (CT) and two parameters (time-to-peak [TTP] and P2/P1 ratio) of a non-invasive ICP wave morphology monitor (Brain4care[B4c]). Intracranial hypertension was defined as an invasively measured ICP > 20 mmHg for at least five minutes.
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
- •Adult inpatients from a dedicated neurological intensive care unit with ischemic (IS) or hemorrhagic stroke who needed invasive ICP monitoring were prospectively evaluated from March 2019 to March 2020 (before the COVID-19 pandemic).
排除标准
- •We excluded patients with chronic neurological diseases (demyelinating diseases, chronic hydrocephalus, pseudotumor brain), suspected brain death, and patients monitored with non-ventricular sensors (e.g., subdural or epidural).
结局指标
主要结局
Comparison between ICP morphology between a non invasive (Brain4care [B4c]) and a invasive (intraventricular) method
时间窗: At least 30 minutes for every patient
Parameter of the ICP wave between methods were compared (Time-to-Peak)
次要结局
- Estimation of Intracranial Hypertension using Transcranial Doppler(At least 5 minutes after EVD closure)
- Estimation of Intracranial Hypertension using optic nerve sheath diameter (ONSD)(At least 5 minutes after EVD closure)
- Estimation of Intracranial Hypertension using a non-invasive ICP wave parameter (P2/P1 ratio).(At least 5 minutes after EVD closure)
- Estimation of Intracranial Hypertension using a non-invasive ICP wave parameter (Time-to_peak).(At least 5 minutes after EVD closure)
- Estimation of Intracranial Hypertension using a 5-point visual scale designed for Computed Tomography (CT)(At least 5 minutes after EVD closure)
研究者
Gisele Sampaio Silva
Profa. Dra Gisele Sampaio Silva
Federal University of São Paulo