Quantification of Cerebral Perfusion at the Patient's Bedside When Performing Contrast-enhanced Ultrasound in Neurointensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of the heterogeneity of brain perfusion by peak-intensities (PI) measurement
研究概览
简要总结
The objective of the study is to assess brain tissue perfusion by contrast-enhanced ultrasound perfusion imaging (PerCEUS) in acute brain injuries. More precisely, it aims :
- to evaluate the heterogeneity of brain perfusion and thus diagnose brain tissue hypoperfusion with contrast-enhanced ultrasound.
- to correlate contrast-enhanced ultrasound with perfusion measurements by usual multimodal monitoring.
详细描述
The main aim is to evaluate the heterogeneity of brain perfusion, thus diagnosing brain tissue hypoperfusion with PerCEUS, then to correlate it with the usual multimodal monitoring.
Earlier after hospitalization in neurointensive care, when the study physician needs to realize a contrast ultrasound imaging and without delaying any emergency procedure, a PerCEUS will be performed in patients with an acute brain injury. After acquisition, data from PerCEUS will be transferred to an external evaluation unit and analysed offline, using commercially available software Qlab (Philips ®). According to the localization of acute brain injuries with magnetic resonance imaging (MRI) and/or computed tomography (CT), several regions-of-interest (ROI, at least three in each area) will be chosen :
- Area 1 : in the core of the lesion (supposed non perfused)
- Area 2 : just next to the lesion (supposed hypoperfused)
- Area 3 : in the saner hemisphere, symmetrically to area 2 each time it's possible (supposed well-perfused).
Every parameters of multimodal monitoring used at the moment of PerCEUS will be relieved :
- intracranial pressure (ICP), cerebral perfusion pressure (CPP), mean arterial pressure (MAP)
- mean flow velocity (MFV) by transcranial doppler (TCD)
- regional cerebral oxygen saturation (rSO2) by Near infrared spectroscopy (NIRS)
- jugular venous oximetry (SjvO2).
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
- •Intensive care unit admission for acute brain injury
- •Proven acute brain injury by CT and/or MRI
- •Requiring a contrast ultrasound imaging
- •Informed consent of patient or relative
排除标准
- •Pregnancy
- •Not sufficient temporal window
- •Contraindications to Sonovue ® : acute coronary syndromes, severe ischemic heart disease (requiring revascularization), pulmonary arterial hypertension > 90 mmHg, right-left shunt, ARDS, dobutamine's use, known allergy or adverse reaction to Sonovue®
- •Patient on State Medical Assistance
结局指标
主要结局
Evaluation of the heterogeneity of brain perfusion by peak-intensities (PI) measurement
时间窗: 30 minutes after PerCEUS
Comparison between peak-intensities (PI) measured in ROIs in each area by PerCEUS
Evaluation of the heterogeneity of brain perfusion by time-to-peak (TPI) measurement
时间窗: 30 minutes after PerCEUS
Comparison between time-to-peak (TPI) intensities measured in ROIs in each area by PerCEUS
次要结局
- Correlation between PerCEUS parameters and cerebral perfusion as assessed by SjvO2(30 minutes after PerCEUS)
- Correlation between PerCEUS parameters and cerebral perfusion as assessed by TCD(30 minutes after PerCEUS)
- Correlation between PerCEUS parameters and cerebral perfusion as assessed by NIRS(30 minutes after PerCEUS)
- Correlation between PerCEUS parameters and cerebral perfusion as assessed by ICP and MAP(30 minutes after PerCEUS)