A Comparative Study Between a Pre-hospital and an In-hospital Circulatory Support Strategy (ECMO) in Refractory Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Survival with good neurological outcome (CPC 1 or 2)
研究概览
简要总结
Cardiac arrest (CA) affects approximately 40,000 people in France. It is still a major cause of death in a young population. Management of CA is defined by international recommendations, detailed by learned societies in each country. It includes several links that are interconnected for its optimisation. Despite all these improvements, no progress, or little has been made in the survival of CA victims over the past few years in industrialised countries, and the survival rate in France is 3% to 5%.
Refractory cardiac arrest is defined as failure, after 30 minutes of specialised resuscitation. It used to be the standard to admit that there was no hope of spontaneous cardiac activity and satisfactory neurological recovery after this period, except in cases of CA with neuroprotection (intoxication, hypothermia).
External circulatory support such as "extracorporeal membrane oxygenation" (ECMO) makes it possible to replace the circulatory activity of the myocardium and the respiratory activity of the lungs.
In in-hospital cardiac arrest (CA) some teams use ECMO with an improvement in the survival rate of 20% in comparison to standard resuscitation. This use demonstrates the possibility of neurological recovery independent of the recovery of spontaneous cardiac activity which can be differed.
These results encouraged the use of ECMOs in cases of out-of-hospital refractory cardiac arrests. Patients who are victims of CA are resuscitated for 30 minutes on the spot where the CA occurs. They are then transferred to a specialised centre. The significant improvement in survival noted in in-hospital CAs was not observed in the French series of studies concerning out-of-hospital CAs. This survival is currently estimated at 4%. This difference can be partly explained by the difference in time between the beginning of cardiac massage and the implementation of circulatory support by ECMO ("low flow" period). This time period is directly correlated to survival.
To demonstrate the superiority of this strategy in terms of survival, investigators would like to conduct a randomised comparative study of two strategies: 1) installation of an ECMO between the 20th minute to the 30 minute of CA, directly at the site of the CA, by emergency physicians and/or specifically trained resuscitators 2) On-site resuscitation optimised with secondary transfer to the hospital for the implementation of support. The purpose is to increase by 5% to 20% the survival of victims of out-of-hospital refractory cardiac arrests with a good neurological prognosis.
Main objective:
The hypothesis is that pre-hospital ECMO will result in survival for 20% of the patients, considering that the percentage of survival with in-hospital ECMO is less than 5%.
Main judgement criterion:
Survival with good neurological outcome (CPC 1 or 2) on discharge from intensive care or at 6 months
Secondary judgement criteria:
Success rate of the implementation of ECMO ECMO implementation time Immediate complications: haemorrhage, infection Number of organ harvesting The quality of survivors' neurological status according to the CPC neurological classification at D 28, 2 months and 1 year Predictive indicators of the prognosis during cardiac arrest via cerebral and biological monitoring Methodology, type of study: This is a prospective randomised study of current care Sample size (SS, power, risk): A total number of 105 patients in each group will make it possible to demonstrate at the alpha risk of 5% and a power of 1-β=90%, a significant difference in favour of early pre-hospital ECMO compared to the current practice with in-hospital ECMO.
详细描述
1 STATUS OF THE QUESTION 2.1 Circumstances surrounding the problem: 2.1.1 The limits of conventional resuscitation in cardiac arrests. Sudden adult death, unexpected cardiac arrest (CA) most often related to cardiovascular causes, affects more than 40,000 people in France every year.
The prognosis of out-of-hospital sudden death is particularly sombre. Only 5 to 20% of the patients survive without neurological sequel. This prognosis can be partially improved by an efficient organization of management that implements the concept of the "survival chain". An early alert by witnesses of the CA, carrying out the first interventions, cardiopulmonary resuscitation (CPR), defibrillation by the public or persons qualified in first-aid, followed by specialized resuscitation by a medical team (such as the ambulance service) increase the amount of survivors. The reduction in the time that passes before the first interventions (called the no-flow period) and the duration of resuscitation before return of spontaneous circulation (ROSC) called low-flow, are considered to be the primary predictive factors of survival in CA.
Just recently, better knowledge of post-cardiac arrest syndrome also contributed to an improvement in the prognosis and the quality of survival. The introduction of early angioplasty and the generalisation of therapeutic hypothermia now complete management for which coding is steadily improving through international and national recommendations that are updated every 5 years. However, in order to show what it is capable of, this conventional management of CA requires spontaneous cardiac activity to be re-established as quickly as possible. Therefore, a return of spontaneous circulation (ROSC) must be obtained in the field in out-of-hospital sudden deaths.
Classically, in the absence of ROSC after 30 minutes of correctly administered resuscitation, the CA is considered to be refractory and the treatment options are limited. Just recently, it was shown that the chances of survival are non-existent after 16 minutes of resuscitation. In most cases, resuscitation is discontinued and the patient is declared dead on the spot. The regulatory inclusion of a physician on ambulance service teams relieves the difficulty of this decision. It is often simple to make and is medically indisputable when it is obvious that the prognostic factors are very unfavorable (notably, an extended no-flow period) and/or the conditions (advanced age, severe chronic disease, etc...) are not compatible with prolonged resuscitation. This decision is much more difficult when the prognostic factors are favorable and prolonged resuscitation efficiently provides spontaneous circulation (signs of the patient awaking during CPR). Under these circumstances, in France and several other European countries, the decision can be made to continue extracorporeal membrane oxygenation (ECMO) and transport the refractory CA victim. It was made possible by the development of mechanical external cardiac massage devices such as Autopulse ® and Lucas® which enable prolonged cardiac compression during transport by the emergency service. However, this continuation of resuscitation can only be considered if it enables another subsequent treatment for the patient. Two options are possible. The patient can be declared dead and become a potential organ donor in the framework of an organ harvesting procedure in a patient after "cardiac death". This harvesting, which is highly organized according to regulations, can only be done in certain hospitals authorized by the French Biomedicine Agency.
Or, resuscitation can be prolonged by the use of extracorporeal circulatory support.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients have the following combination of criteria:
- •Adults over 18 years of age and under 65 years of age
- •And Refractory cardiac arrest (defined by the failure of professionals to resuscitate at the 20th minute of cardiac arrest with a minimum of 3 Automatic External Defibrillator (AED) or equivalent analyze
- •And Beginning of external cardiac massage within the first 5 minutes after cardiac arrest (no flow < 5 min.) with shockable rhythm or the presence of signs of life during resuscitation (any rhythm): spontaneous movement, absence of mydriasis and/or pupillary response, spontaneous breathing movements
- •And Medical cause of the cardiac arrest
- •And End-Tidal CO2 (ETCO2) above 10 mm Hg at the time of inclusion
- •And Absence of major co-morbidity. And Extra-corporeal Membrane Oxygenation (ECMO) team available and on-site before the 40th minute
排除标准
- •Children under 18 years of age
- •Adults over 65 years of age
- •Period of more than 5 minutes without cardiac massage after collapsing
- •Known co-morbidity that compromises the prognosis for short or medium-term survival
- •Cardiac arrest during transportation times
研究组 & 干预措施
Pre hospital ECMO
ECMO Insertion on pre hospital setting for a refractory cardiac arrest
干预措施: ECMO Insertion on pre hospital setting (Other)
In Hospital ECMO
ECMO Insertion on in hospital setting for a refractory cardiac arrest
干预措施: In Hospital ECMO (Other)
结局指标
主要结局
Survival with good neurological outcome (CPC 1 or 2)
时间窗: At 6 months or participants will be followed for the duration of hospital stay, an expected average of 6 weeks
次要结局
- The quality of survivors' neurological status according to the CPC neurological classification at 2 months(2 months)
- Predictive indicators of the prognosis during cardiac arrest via cerebral and biological monitoring (pupils reflex, breathing, gasp, movement, Cerebral saturation, pupils diameters,and lactates)(6 Months)
- Success rate of the implementation of ECMO(Immediate)
- ECMO implementation time(Immediate)
- Immediate complications: haemorrhage, infection(One day)
- Number of organ harvesting(6 months)
- The quality of survivors' neurological status according to the CPC neurological classification at D 28(28 days)
- The quality of survivors' neurological status according to the CPC neurological classification at 1 year(1 year)
