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Non Invasive Neuromonitoring After Cardiac Arrest (NINCA)

2017年4月18日 更新者:Icahn School of Medicine at Mount Sinai

Phase 2 Prospective, Observational, Pilot Study of Noninvasive Monitoring of Regional Cerebral Blood Flow for the Evaluation of Brain Tissue Perfusion During and After Resuscitation for Cardiac Arrest

Cardiac Arrest is among the leading causes of death, with survival still well under 50% and the majority of the survivors suffering from moderate to severe neurologic deficits. The human, social and economic costs are staggering.

During resuscitation, damage is mitigated if chest compressions and other medical care are optimal, allowing some blood to reach the brain and some oxygen to reach the cells. Once the heart starts beating again, which is called return of spontaneous circulation, brain perfusion is reestablished, but usually not to normal. The now damaged brain is very fragile, can be sensitive to any changes in blood pressure or metabolic abnormalities, and swelling might set in. Hypoperfusion can persist, without the clinician's knowledge. All of these events further damage the brain and diminish the odds that the patient will regain a normal life. Therefore, the hours following return to spontaneous circulation are critical to the patient's future recovery, and constitute a window of opportunity to maximize the brain ability to heal.

In order to optimize resuscitative efforts and post-arrest management, clinicians must know what is actually happening with the most vital organ, the brain. The problem is that it is very difficult to do in a comatose patient. The available technologies only reveal indirect evidence of brain suffering, like the swelling on CT-scans, but not to continuously evaluate at the bedside if the brain actually receives enough blood.

The FDA recently approved a device named the c-flow, made by ORNIM. This device looks at red blood cells in the brain and the speed at which they move to evaluate an index of cerebral perfusion. It does so with sensors put on the patient's forehead, which emit and detect ultrasounds and infrared light. This index can inform the clinician about the amount of blood flow the brain receives, and it can be put in place very quickly, even during resuscitative efforts, and without any danger for the patient.

The study looks at how well the information obtained with the c-flow matches the one obtained from other indirect indices and, more importantly, how well it predicts patient outcome. The investigators wish to establish threshold values of this index of perfusion that predict a good recovery so that this information may be used to optimize patient's neurological outcome in the near future.

研究概览

详细说明

Primary Objective:

Cardio-Pulmonary Resuscitation (CPR) is undergoing a major paradigm shift, with new emphasis on optimizing neurological recovery. As a result, Cardio-Cerebral Resuscitation (CCR) is now the preferred term for describing protocols directed at promoting survival and recovery from cardiac arrest. Establishing and maintaining brain perfusion is the critical endpoint of resuscitation; however, there is currently no simple and reliable way to evaluate the adequacy of brain tissue perfusion in cardiac arrest patients. The overall goal of the NINCA study is to determine if non-invasive cerebral blood flow index (CFI) can be used as a simple and effective measurement of brain perfusion during and after resuscitation from cardiac arrest. Our researchers hypothesize that this monitoring may one day be routinely used to (1) evaluate the adequacy of chest compressions, (2) avoid brain tissue hypoperfusion induced by excessive hyperventilation or shivering, (3) serve as an endpoint for goal-directed hemodynamic support, (4) evaluate the potential for neurological recovery, and (5) help guide post-cardiac arrest care.

Implications for Further Research:

Successful completion of the research will hopefully establish that non- invasive cerebral blood flow monitoring is feasible during and after CPR; is dependent on adequate MAP, CO, temperature, SpO2 and ventilation; and is a valid predictor of neurological recovery. If confirmed, such monitors may one day become part of standard ICU post-cardiac arrest monitoring and even be part of standard resuscitation equipment.

Determination of optimal CFI thresholds or targets will support future studies to determine if "goal directed" and individualized post-resuscitation ICU care is feasible using non-invasive cerebral perfusion indices. This could lead to a new way of optimizing hemodynamic support, temperature management and ventilation strategies to maintain adequate cerebral perfusion and improve neurological outcomes.

研究类型

观察性的

注册 (实际的)

21

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10029
        • Mount Sinai Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Comatose survivors of cardiac arrest

描述

Inclusion Criteria:

  • Age ≥18 years
  • Sustained ROSC within 60 minutes of arrest
  • Patient is comatose (unresponsive and unable to follow verbal commands) after resuscitation

Exclusion Criteria:cerebral perfusion

  • Partially or fully dependant functional status prior to index cardiac event
  • Acute traumatic brain injury, SAH, massive stroke or intracranial hemorrhage
  • Initiation of monitoring is not feasible for logistical reasons
  • Urgent surgery planned
  • Severe co-morbidity or terminal illness which makes survival to 3 months unlikely
  • Pregnancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Cardiac arrest
Consecutive adult cardiac arrest patients with sustained ROSC in an academic medical center
As soon as possible after ROSC, c-flow monitor will be connected to the patient, recording cerebral flow index for the first 72 hours following ROSC. All other relevant clinical data will be recorded.
其他名称:
  • c-flow monitor (ORNIM)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cerebral Performance Category
大体时间:7 days
Neurological Outcome by good functional recovery
7 days
Modified Rankin Scale
大体时间:7 days
Neurological Outcome
7 days

次要结果测量

结果测量
措施说明
大体时间
Survival Rate
大体时间:7 days
Survival with good functional recovery
7 days

其他结果措施

结果测量
措施说明
大体时间
MoCA
大体时间:7 days
Cognitive outcome
7 days
EQ-5L-5D
大体时间:7 days
quality of life outcome
7 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Stephan A Mayer, MD、Neurology Department, Mount Sinai Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年10月1日

初级完成 (实际的)

2016年3月21日

研究完成 (实际的)

2016年3月21日

研究注册日期

首次提交

2015年10月12日

首先提交符合 QC 标准的

2015年10月13日

首次发布 (估计)

2015年10月14日

研究记录更新

最后更新发布 (实际的)

2017年4月19日

上次提交的符合 QC 标准的更新

2017年4月18日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GCO 15-1105

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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