Cerebral Near Infrared Spectroscopy in Out-of-Hospital Cardiac Arrest and Neurological Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 542
- 试验地点
- 12
- 主要终点
- Cerebral Performance Category (CPC)
研究概览
简要总结
Out-of-hospital cardiac arrest (OHCA) prognosis remains poor : 7% of patients surviving without neurological impairment.
65% of patients dying after hospital admission were neurologically impaired. When treating a patient with CA, neurological outcome remains extremely difficult to predict, especially in the pre-hospital setting. Practitioners have very little objective information to help them with neuropronostication.
Although an EtCO2 level of < 10 mmHg is associated with a poor neurological prognosis, European recommendations point out that this data alone is not currently sufficient to predict a patient's prognosis or to make a decision to stop resuscitation. Current recommendations do not suggest any other objective parameter during resuscitation for neuropronostication of patients with out-of-hospital cardiac arrest.
Cerebral tissue oxygen saturation (rSO2) is measured using the near infrared spectrometry (NIRS) technique. Cerebral NIRS (cNIRS) enables non-invasive measurement of changes in cerebral oximetry during the management of a cardiac arrest (CA).
Various clinical studies conducted over the last ten years have demonstrated that there is a probable link between cNIRS levels during resuscitation and return of spontaneous circulation (ROSC), but a clear threshold value has not been defined.
The aim of the NISOHCA study is to confirm that a 40% threshold of cNIRS in the pre-hospital setting for OHCA can specifically predict survival with good neurological outcome at D90 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Age ≥ 18 years.
- •Non-traumatic out-of-hospital cardiac arrest witnessed and managed by the mobile emergency unit (SMUR).
排除标准
- •Scalp/cranial or facial injury preventing the placement of electrodes for NIRS measurement.
- •Spontaneous cardiac activity upon the arrival of the SMUR.
- •Decision by the SMUR physician not to initiate specialized resuscitation.
结局指标
主要结局
Cerebral Performance Category (CPC)
时间窗: Day 90
Specificity of predicting a 90-D survival with a good neurological outcome with a mean c-NIRS \> 40% during Cardiopulmonary Resuscitation (CPR). Cerebral Performance Category (CPC) of 1 to 5. CPC 1: Complete recovery without neurological impairment or conscious with minor impairment. CPC 5: Deceased or brain dead.
次要结局
- Cerebral Performance Category (CPC)(Day 90)
- Cerebral Performance Category (CPC) after Return of Spontaneous Circulation(ROSC)(Day 90)
- Return of Spontaneous Circulation(1 hour)
- The cumulative dose of adrenaline.(During out-of-hospital cardiopulmonary resuscitation.)
- Resuscitation duration.(During out-of-hospital cardiopulmonary resuscitation.)
- No-flow duration(During out-of-hospital cardiopulmonary resuscitation.)
- Initial rhythm (Shockable or non-Shockable)(During out-of-hospital cardiopulmonary resuscitation.)
研究者
JAEGER Deborah
Coordinating Investigator
Central Hospital, Nancy, France