NCT03249220进行中（未招募）不适用
Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device That Allows the Measurement of Regional Cerebral Blood Flow (rCBF), Intracranial Pressure (ICP), Brain Temperature Monitoring and Ventricular Cerebrospinal Fluid (CSF) Drainage in Brain-injured Patients
Carag AG4 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2020年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD
研究概览
简要总结
Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain temperature monitoring and ventricular cerebrospinal fluid (CSF) drainage in brain-injured patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female patient, aged 18 - 75 years
- •Brain injured patients with acute intracranial hemorrhage (including aneurysmal subarachnoid hemorrhage (SAH) and spontaneous intracerebral hemorrhage (ICH)) who are admitted to the ICU and have an indication for ICP monitoring and CSF drainage, as per standard patient care
- •Informed consent obtained for research in emergency situations according to HRA art. 30 & 31 at time of inclusion
排除标准
- •Known kidney disease, defined as plasma creatinine > 120 μmol/l
- •Known liver disease, defined as AST > 200 IU/L
- •Over-active thyroid or benign tumors of the thyroid
- •History of allergic disorders, including allergic reactions, against contrast agents containing iodine, or against ICG
- •Patients which have received one of the following medications before being admitted to ICU: Haloperidol, Meperidine, Methadone, Morphine, Phenobarbital and Rifamycin.
- •Patients with wounds or scars including the front orbital region.
- •Cerebrospinal fluid infection or signs of meningo-encephalitis
- •Anemia (hemoglobin < 10 g/dl) or Thalassemia
- •Carbon monoxide poisoning
- •Acquired pathological or congenital disorders of the cerebral system, being clinically significant, respectively interfering in the investigator's opinion with the conduct of study
- •Documented history of bleeding, clotting or coagulation disorders
- •Patients who are not suitable for a CT perfusion
- •Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this clinical investigation or will not comply with requirements of the study
- •Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation
- •Pre-existing disability and/or legal representative
- •Patients who are kept lawfully in an institution
- •Participation in another interventional clinical investigation within the last 30 days before start of treatment
- •History of, respectively diagnosis of pregnancy, or breastfeeding patients
结局指标
主要结局
Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD
时间窗: Up to 28 days until probe removal
Regional CBF values calculated with the investigational devices (CBMS) are within ranges described in literature, and dynamic changes of regional CBF are consistent to those values obtained with established methods CT perfusion and TCD.
次要结局
- Safety related to catheter insertion and monitoring(Until 7 days after probe removal)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
A New Minimal-invasive Brain Tissue Probe Applying Near Infrared SpectroscopySpontaneous Subarachnoid HemorrhageNCT01801306NeMoDevices AG3
已完成
不适用
A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain InjuryOptical ImagingSubarachnoid HemorrhageNCT01802762NeMoDevices AG16
已完成
1 期
A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy VolunteersCerebral IschemiaNCT00598819University of California, Irvine14
终止
不适用
A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery PatientsHeart Valve DiseaseCoronary Artery DiseaseNCT00598936University of California, Irvine21
已完成
不适用
Pilot Study of NeuroTriage Device in Patients with Potential Brain Injury And/or ImpairmentTraumatic Brain InjuryNCT03761641University of Texas Southwestern Medical Center24