Menu
Recruiting NCT06397417

Refractory Cardiac Arrest Treated On Field By ECMO

Observational Out-of-Hospital Cardiac Arrest Extracorporeal Cardiopulmonary Resuscitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection.
Who it may be relevant to
Registry conditions: Out-of-Hospital Cardiac Arrest, Extracorporeal Cardiopulmonary Resuscitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prognosis of Refractory Out-of-hospital Cardiac Arrests Treated With Extracorporeal Cardiopulmonary Resuscitation (ECMO) by the Urgent Medical Aid Service (SAMU) of Paris

Overview

Out-of-hospital cardiac arrest without resumption of spontaneous circulatory activity despite advanced medical resuscitation is considered refractory. Under certain well-defined conditions, today in many cities around the world and particularly in Paris, it benefits from resuscitation called ECPR (extracorporeal cardiopulmonary resuscitation). This technique consists of the installation of an extracorporeal membrane oxygenation (ECMO) device allowing organ perfusion while waiting for a resumption of cardiac activity. Since 2011, the Paris SAMU (SAMU 75) has set up a team capable of implementing ECPR for refractory out-of-hospital cardiac arrests. This team based within the SAMU of Paris at the Necker hospital (ECMO team) composed of an emergency doctor or anesthesiologist-resuscitator, a nurse anesthetist and an ambulance driver intervenes in Paris and its nearby region at the request of medical regulation. Given the growing development of this activity, it is essential to measure its effectiveness in real-life conditions.

Detailed description

Out-of-hospital cardiac arrest without resumption of spontaneous circulatory activity despite advanced medical resuscitation is considered refractory. Under certain well-defined conditions, today in many cities around the world and particularly in Paris, it benefits from resuscitation called ECPR (extracorporeal cardiopulmonary resuscitation). This technique consists of the installation of an extracorporeal membrane oxygenation (ECMO) device allowing organ perfusion while waiting for a resumption of cardiac activity. Since 2011, the Paris SAMU (SAMU 75) has set up a team capable of implementing ECPR for refractory out-of-hospital cardiac arrests. This team based within the SAMU of Paris at the Necker hospital (ECMO team) composed of an emergency doctor or anesthesiologist-resuscitator, a nurse anesthetist and an ambulance driver intervenes in Paris and its nearby region at the request of medical regulation. Given the growing development of this activity, it is essential to measure its effectiveness in real-life conditions.

The study consists of establishing a prospective register over a period of 20 years of patients aged over 18 years, victims of refractory non-traumatic out-of-hospital cardiac arrest in the coverage area of the ECMO TEAM of the Paris SAMU.

The 1-year survival rate of patients will be measured, the functional prognosis will be evaluated and a search for associated factors will be carried out. Patients' long-term cardiac function will be collected as well as the incidence of ECPR-related complications.

Interventions

  • Other Data collection
    The data from hospital treatment will be used for research as well as subsequently, that is to say after discharge from the intensive care units, medical reports and correspondence with the attending physician will be used for the study.

Primary outcome measures

  • Survival [Time frame: 1 year]
Secondary outcome measures (5)
  • Neurological prognosis [Time frame: 1 year]
  • Quality of life assessment [Time frame: 1 year]
  • Incidence of ECPR-related complications [Time frame: 1 year]
  • Left ventricular ejection fraction (LVEF) [Time frame: 1 year]
  • Occurrence of major cardioavscular events [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • All patients who have benefited from an installation or attempted installation of an extracorporeal membrane oxygenation (ECMO) device following a non-traumatic refractory cardiac arrest as part of the ECMO TEAM of the Samu de Paris during the time of the study.
  • Obtaining non-opposition from the patient or a relative in the event of the patient's death or a lasting state of health preventing them from becoming aware of the study.

Exclusion criteria

\- Minor patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital Necker-Enfants Malades — Paris

Identifiers

NCT: NCT06397417 · APHP231680

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗