Research and Development of Innovative Method and Technology for Cerebral Perfusion Pressure Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cerebral autoregulation index (pressure reactivity index PRx)
研究概览
简要总结
The research will investigate the hypothesis that timely identification of the optimal value of the cerebral perfusion pressure (optCPP) or optimal arterial blood pressure (optABP) is possible after detecting informative episodes of arterial blood pressure (ABP) that reflects the physiological autoregulatory reactions of the cerebral blood flow,
This biomedical study will be conducted to test this hypothesis and to develop an algorithm for identification of optimal brain perfusion pressure within limited time (several tens of minutes).
The goal of this observational study is to test the method of timely optimal cerebral perfusion pressure value or optimal arterial pressure value in intensive care patients after brain surgery.
The main question it aims to answer are: how long it takes to identify optimal cerebral perfusion value when arterial blood pressure is changing within safe physiological limits.
Objectives of the study
- To perform a prospective observational study by collecting multimodal physiological brain monitoring data: intracranial pressure (ICP), arterial blood pressure (ABP), End-tidal carbon dioxide (ETCO2), cerebral blood flow velocity (CBFV), ECG.
- To perform a retrospective analysis of the accumulated clinical monitoring data, in order to create an algorithm for the identification of informative monitoring data fragments, according to which it would be possible to identify the optimal cerebral perfusion pressure (optCPP) value in a limited time interval (within a few or a dozen minutes).
- To perform a retrospective analysis of accumulated clinical monitoring data, determining correlations of cerebral blood flow autoregulation and optCPP-related parameters with the clinical outcome of patients and with the risk of cerebral vasospasm or cerebral ischemia.
详细描述
Optimal cerebral perfusion pressure (optCPP) management requires at least 4 hours of patients' physiological data monitoring. Critical pathophysiological events in the injured brain happen in minutes, not in hours.
The research will investigate the hypothesis that timely identification of the optimal value of the cerebral perfusion pressure (optCPP) or optimal arterial blood pressure (optABP) is possible after detecting informative episodes of arterial blood pressure (ABP) that reflects the physiological autoregulatory reactions of the cerebral blood flow,
This biomedical study will be conducted to test this hypothesis and to develop an algorithm for identification of optimal brain perfusion pressure within limited time (several tens of minutes).
The goal of this observational study is to test the method of timely optimal cerebral perfusion pressure value or optimal arterial pressure value in intensive care patients after brain surgery.
The main question it aims to answer are: how long it takes to identify optimal cerebral perfusion value when arterial blood pressure is changing within safe physiological limits.
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
- •Traumatic brain injury patients
- •Subarachnoid hemorrhage patients
排除标准
- •persons with mental disorders, but who can give consent to participate in biomedical research;
- •students, if their participation in biomedical research is related to studies;
- •persons living in care institutions;
- •soldiers during their actual military service;
- •employees of health care institutions where biomedical research is conducted, subordinate to the researcher;
结局指标
主要结局
Cerebral autoregulation index (pressure reactivity index PRx)
时间窗: PRx is measured when invasive intracranial pressure slow waves and arterial pressure slow waves are available during multimodal clinical data collection in ICU (up to 7 days).
Negative values of cerebral autoregulation index (PRx\<0) represent intact cerebral autoregulation, positive values (PRx\>0) show impaired cerebral autoregulation.
Cerebral autoregulation index (mean flow index Mx)
时间窗: Mx is measured when non-invasive cerebral blood flow slow waves and arterial pressure slow waves are available during multimodal clinical data collection in ICU (up to 7 days).
Negative values of cerebral autoregulation index (Mx\<0) represent intact cerebral autoregulation, positive values (Mx\>0) show impaired cerebral autoregulation.
Optimal arterial blood pressure value
时间窗: Optimal arterial blood pressure value is identified when PRx or Mx data are available during multimodal clinical data collection in ICU (up to 7 days).
Optimal arterial blood pressure value is identified at the conditions of lowest values of cerebral autoregulation indexes by applying "U-shape" approximation on ABP and PRx (or Mx) data. Identified optimal arterial blood pressure value is assumed as a targeted arterial blood pressure value for personalized cerebral perfusion management in the cases when U-shape approximation is determined.
次要结局
- Patients' outcome(GOS is evaluated at discharge from hospital and after 30 days of patient's hospital admission.)
- Occurrence of cerebral ischemia and cerebral vasospasms(CT and CTA scans is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary.)