NCT Number: NCT06397417
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, 75015, France
Location status: Recruiting
Alice HUTIN, MD
SUB_INVESTIGATOR
Damien VIMPERE, MD
SUB_INVESTIGATOR
Jean-Herlé Raphalen, MD
CONTACT
1 71 19 63 46 ext. +33
Kim AN, MD
SUB_INVESTIGATOR
Lionel LAMHAUT, MD, PhD
SUB_INVESTIGATOR
Tal SOUMAGNAC, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 year
Survival rate at 1 year after an extracorporeal cardiopulmonary resuscitation by the ECMO TEAM of the Paris SAMU.
Time frame: 1 year
Evaluation of the functional prognosis at 1 year by the score at the Cerebral Performance Category Scale. A favorable outcome is defined by a score of 1 or 2. The score on the brain performance category scale will be determined based on hospital records and/or telephone interview with the general practitioner. The CPC score: [5: death, 4: persistent vegetative state, 3: severe disability, 2: moderate disability, 1: low disability].
Time frame: 1 year
Evaluation of the functional prognosis at 1 year by measure of the quality of life assessed by the Short Form (36) Health Survey (SF36). The SF-36 test is a standardized questionnaire for measuring quality of life. It is carried out during a follow-up medical consultation. Description of the overall SF36 score and each of its eight sections (vitality, physical functioning, bodily pain, general health perception, physical role functioning, emotional role functioning, social role functioning, mental health).
Time frame: 1 year
Measurement of the incidence of complications linked to ECPR (extracorporeal cardiopulmonary resuscitation) : bleeding at the cannula puncture site, lower limb ischemia, post-load pulmonary edema, bacteremia, insertion site infection.
Time frame: 1 year
Assessment of long-term cardiac function based on the data from the imaging reports carried out by the downstream services and/or the telephone interview with the general practitioner or specialist doctor.
Time frame: 1 year
Report of occurrence of major cardioavscular events through analysis of medical reports within one year after cardiac arrest. Major cardioavscular events are defined as : recurrence of cardiac arrest, acute coronary syndrome, ventricular rythm disorders, acute heart failure.
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Prognosis of Refractory Out-of-hospital Cardiac Arrests Treated With Extracorporeal Cardiopulmonary Resuscitation (ECMO) by the Urgent Medical Aid Service (SAMU) of Paris
Acronym: ReCATOBE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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