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临床试验/NCT04134078
NCT04134078Unknown早期 1 期

Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Stony Brook University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
100
试验地点
1
主要终点
Rate of return of spontanueous circulation (ROSC)

研究概览

简要总结

Sudden cardiac arrest (CA) is a leading cause of death worldwide. CA claims the lives of an estimated 300,000 Americans each year. Despite advances in cardiopulmonary resuscitation (CPR) methods, only approximately 10% of adults with CA survive to hospital discharge, and up to 60% of survivors have moderate to severe cognitive deficits 3 months after resuscitation. Most of the immediate and post-CA mortality and morbidity are caused by global ischemic brain injury. The goal of this grant application is to test the hypothesis that resuscitation from cardiac arrest can be improved by improving cerebral oxygenation through inhalation of nitric oxide. This strategy will also improve the chances of return of spontaneous circulation (ROSC), improve short-term survival and neurologic outcome.

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

  • Age 18 years and above
  • In-hospital cardiac arrest as defined by cessation of heartbeat
  • Presence of Endotracheal Tube

排除标准

  • Age below 18 years
  • Absence of Endotracheal Tube
  • Patients with out-of-hospital cardiac arrest
  • Patients involved in trauma and/or patients in the SICU or CTICU
  • Preexisting intra-cerebral lesions such as any head injury (old or new), brain hematoma, cerebral hemorrhage or known frontal lobe disorders such as tumors
  • Any patient with a terminal condition that cannot be treated (specifically any terminal malignancy, end stage lung fibrosis, chronic heart failure with an ejection fraction <20%)
  • Patients with do not resuscitate and/or do not intubate (DNR/DNI) status
  • Therapeutic window has passed

研究组 & 干预措施

inhaled nitric oxide

Experimental

Inhaled Nitric Oxide at 40 ppm will be administered in adults who suffer in hospital cardiac arrest. The administration of inhaled nitric oxide at 40 ppm will be provided upto 24 hours once ROSC is achieved.

干预措施: inhaled nitric oxide (Drug)

结局指标

主要结局

Rate of return of spontanueous circulation (ROSC)

时间窗: 1 day

The primary outcome measure is to evaluate rates of return of spontaneous circulation (ROSC) from in hospital cardiac arrest patient who receive inhaled nitric oxide

Change in cerebral oxygenation (rSO2)

时间窗: 1 day

The outcomes measure is to evaluate change in the concentration of cerebral oxygenation measured by Near-infrared spectroscopy before and after the administration of inhaled nitric oxide

次要结局

  • Neurologic outcomes at hospital discharge(upto 24 weeks)
  • short term survival(upto 24 weeks)

研究者

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

Jignesh Patel

Associate Professor of Medicine

Stony Brook University

研究点 (1)

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