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Cardiac Arrest Extra Corporeal Oxygenation Membrane

Refractory Cardiac Arrest Management With Veno-Arterial Extra Corporeal Oxygenation Membrane Registry

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03352999
Acronym
CAREECMO
Enrollment
50
Registered
2017-11-24
Start date
2017-12-01
Completion date
2023-12-01
Last updated
2017-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cardiac Life Support, Cardiac Arrest, Cardiopulmonary Resuscitation, Extracorporeal Life Support

Keywords

Refractory out-hospital cardiac arrest, Extracorporeal Life Support

Brief summary

French guidelines for Cardio Pulmonary Resuscitation (CPR) consider Extra-Corporeal Life Support (ECLS) as one option in Refractory out-of hospital Cardiac Arrest (ROHCA) patients with a no-flow less than five minutes and absence of spontaneous circulation 30 minutes after initiation of advanced CPR. Duration of both pre-CPR arrest (no-flow) and of CPR (low-flow) have been systematically highlighted as crucial prognostic factors in all observational studies focused on ROHCA. In order to shorten the time to ECLS initiation, the most recent European Resuscitation Council guidelines recommend, in eligible ROHCA patients, a fast track access to ECLS implantation. CHRU Nancy elaborated an operational strategy which was designed to improve the enrolment of eligible ROHCA patients and to reduce the delay time between recognition and ECLS initiation. The objective of the present register was to assess prospectively the impact of this new operational strategy over a 5 years period.

Interventions

PROCEDUREFast track access to vaECMO

ROHCA must be witnessed with onset of bystander CPR and an immediate call to Emergency Dispatch. Furthermore, to minimize any loss of time, all qualified geographical locations are directly incorporated in the regulation software of the center for medical emergency control. Patients suitable for vaECMO implantation were identified as early as possible by the Medical Dispatcher at the Emergency Call Dispatch Center. Bystanders pursued CPR until Mobile Intensive Care Unit (MICU) arrival. OHCA was considered refractory after 10 min of CPR initiating the transport by MICU to the hospital such that the vaECMO intervention could be performed. The resuscitation was pursued during the transfer to hospital. An automated chest compression device was used in order to minimize interruption periods. The intensivists and cardiac surgeons stood ready to implant the vaECMO surgically in the catheterization laboratory where a percutaneous coronary intervention was subsequently performed.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Prospective, monocentric, open, routine care assessment study

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Witnessed out-of-hospital cardiac arrest * in qualified geographical locations * No Return of spontaneous circulation (ROSC) after 10 min of CPR * No Flow \<1 min

Exclusion criteria

* Apparent obvious comorbidities * Patient \< 18 yo * Pregnancy * Patient under protective supervision

Design outcomes

Primary

MeasureTime frameDescription
Number of survivors without neurological sequelae Number of survivors without neurological sequelae (DRS scale from 0 to 6)1 yearNumber of survivors without neurological sequelae (DRS scale from 0 to 6)

Secondary

MeasureTime frameDescription
Ischemia-reperfusion assessmentfrom ECMO implantation and day 3Amount of fluid infused
Renal failureECMO implantation - Day 1- Day 3Worst KDIGO stage
Hepatic failureECMO implantation - Day 1 - Day 3Worst values of PT/bilirubin/ AST and ALT
Coagulation FailureECMO implantation- Day 1 - Day 3platelets/PT/Fibrinogen
Respiratory failureECMO implantation - Day 1- Day 3PaO2/iFO2 value
Hemodynamic Failurefrom ECMO implantation and day 3Amount of Norepinephrine infused
Number of survivors with or without neurological sequelae.at 3 monthsNumber of survivors with or without neurological sequelae (DRS from 0 to 29)
Pupillary statusat arrival in intensive care - Hour 0 - Hour 6 - Hour 12 - Day 1Pupillary status
LactateHour 0 - Hour 6 - Hour 12 - Day 1amount of Lactate
bispectral indexat arrival in intensive care - Hour 6 - Hour 12 - Day 1bispectral index
Nosocomial complicationsECMO implantation - Day 1 - Day 3Infection of the canulation site
Bleeding complicationsECMO implantation - Day 1 - Day 3blood hemostasis disorder
Quality of Resuscitationfrom collapse to ECMO implantation (up to 60 minutes)Total duration of the resuscitation: from collapse to ECMO implantation

Contacts

Primary ContactAntoine Kimmoun, MD
a.kimmoun@chru-nancy.fr0033383154079
Backup ContactTahar Chouied, MD
t.chouied@chru-nancy.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026