跳至主要内容
临床试验/NCT03911908
NCT03911908进行中(未招募)2 期

Impact of a NIRS-guided Cardiopulmonary Resuscitation Algorithm Compared to the Current ERC-guideline Algorithm on ROSC Rate and Patient Outcome After In-hospital and Out-of-hospital Cardiac Arrest

Dr. Serge Thal2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
360
试验地点
2
主要终点
successful cardiopulmonary resuscitation (CPR)

研究概览

简要总结

Sudden cardiac death is one of the main causes of morbidity and mortality worldwide. Cardiac arrest requires prompt intervention by cardiopulmonary resuscitation (CPR). The resuscitation guidelines are the current recommendations for CPR and are revised by expert panels such as the "European Resuscitation Council (ERC)".

Up to now, a parameter for assessing the quality of CPR is missing and further monitoring methods are urgently needed.

Near-infrared spectroscopy (NIRS) is a portable method for measuring regional oxygen levels in the brain. Recent clinical trials suggest that cerebral oxygenation measured by NIRS may correlate with survival and outcome after cardiac arrest.

The investigators propose that NIRS technology may not only be suitable to determine or predict the outcome of the patients, but could also be a useful tool to guide the CPR providers to optimize the CPR techniques and guide the individual treatments/interventions.

The present study was therefore designed to determine if NIRS guided CPR with the aim to optimize NIRS values is superior compared to the current standard practice according to published CPR guidelines (return of spontaneous circulation [ROSC] rate, short and long-term cerebral performance).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

On group will have NIRS reading available to adjust CPR interventions, whereas the control group will not be able use NIRS readings (masked by cover)

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

  • Patients with a cardiac arrest from the age of 18 years (in and out-of-hospital cardiac arrest)

排除标准

  • post-traumatic cardiac arrest
  • non-fitting NIRS sensor (size)

结局指标

主要结局

successful cardiopulmonary resuscitation (CPR)

时间窗: DAY 1

Influence of the intervention on the number of patients with successful return of spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR) \[ROSC: yes/no\]

次要结局

  • Time-to-ROSC(DAY 1)
  • Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC)(DAY 30, DAY 180, DAY 360)
  • Glasgow Outcome Scale Extended (GOS-E) after successful return of spontaneous circulation (ROSC)(DAY 30, DAY 180, DAY 360 after successful return of spontaneous circulation (ROSC))
  • The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC)(Discharge from intensive care unit (variable time point, depending on condition of patient))

研究者

发起方
Dr. Serge Thal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Serge Thal

Principal Investigator

Johannes Gutenberg University Mainz

研究点 (2)

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