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临床试验/NCT02069353
NCT02069353终止不适用

Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

Jonathan Elmer1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2015年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
1
主要终点
Occult Seizures

研究概览

简要总结

Cardiac arrest is the most common cause of death in the United States and as many as 590,000 Americans suffering a cardiac arrest each year. Despite advances in care, as many as 50 to 89% of patients who are resuscitated after a cardiac arrest die in the hospital. Brain injury is the most common cause of death and disability after cardiac arrest. The investigators use advanced brain monitoring in patients who are at high risk of death after cardiac arrest, with the goal of preventing ongoing brain injury. The most common problem the investigators have observed is low oxygen levels in the brain, which is often very difficult to treat.

In this study, the investigators plan to use two additional brain monitors in the care of these high risk patients: a monitor for seizures and a monitor of the amount of blood flow in the brain. The investigators will use these to detect and treat potential causes of low brain oxygen levels. The main hypotheses are that electrical events in the brain such as seizures and "spreading depolarizations" will occur during times of low brain tissue oxygen level, and that treating these events and low blood flow will reduce the rate of low brain oxygen levels.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • High risk survivors of cardiac arrest
  • Decision by potential subject's clinical team to use our institutional standard invasive, multimodal neurologic monitoring for post-arrest care

排除标准

  • 未提供

研究组 & 干预措施

Cardiac arrest

Experimental

Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring.

干预措施: QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) (Device)

Cardiac arrest

Experimental

Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring.

干预措施: Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI) (Device)

结局指标

主要结局

Occult Seizures

时间窗: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

Seizures detected by intracortical EEG but not surface EEG

Spreading Depolarizations

时间窗: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

Cerebral Hypoperfusion

时间窗: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

次要结局

  • Monitor-associated Infection(Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks)
  • Clinically Significant Bleeding(Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks)
  • Device Malfunction(Participants will be followed for the duration of invasive monitoring, an expected average of 5 days)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jonathan Elmer

Assistant Professor, Department of Emergency Medicine

University of Pittsburgh

研究点 (1)

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