Health TrialsbyHealthPanel

Refractory Cardiac Arrest Treated On Field By ECMO

ConditionsOut-of-Hospital Cardiac ArrestExtracorporeal Cardiopulmonary Resuscitation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Data collection

    Other intervention

    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.

Treatment groups

840 Participants
are divided into 1 treatment group
Group A: Patients1 intervention

Trial outcomes

Primary outcomes

1

Survival

Survival rate at 1 year after an extracorporeal cardiopulmonary resuscitation by the ECMO TEAM of the Paris SAMU.

Time frame
1 year

Secondary outcomes

1

Neurological prognosis

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
2

Quality of life assessment

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
3

Incidence of ECPR-related complications

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
4

Left ventricular ejection fraction (LVEF)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov
Apply now