Cardiac Arrest Extra Corporeal Oxygenation Membrane

NCT03352999 | Unknown

• 1 other identifier: 2016-A01873-48.
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Refractory out-hospital cardiac arrest; Extracorporeal Life Support

Outcome Measures

Primary Outcomes (1)

• Number of survivors without neurological sequelae Number of survivors without neurological sequelae (DRS scale from 0 to 6)

  Number of survivors without neurological sequelae (DRS scale from 0 to 6)

  1 year

Secondary Outcomes (16)

• Number of survivors with or without neurological sequelae.

  at 3 months

• Number of survivors with or without neurological sequelae.

  at 3 months

• Ischemia-reperfusion assessment

  from ECMO implantation and day 3

• Renal failure

  ECMO implantation - Day 1- Day 3

• Hepatic failure

  ECMO implantation - Day 1 - Day 3

Study Arms (1)

ROHCA rescued by vaECMO

OTHER

Patients experiencing a ROHCA despite advanced CPR and finally rescued with a va ECMO device.

Procedure: Fast track access to vaECMO

Interventions

Fast track access to vaECMO PROCEDURE

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.

ROHCA rescued by vaECMO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (1)

• Chouihed T, Kimmoun A, Lauvray A, Laithier FX, Jaeger D, Lemoine S, Maureira JP, Nace L, Duarte K, Albizzati S, Girerd N, Levy B. Improving Patient Selection for Refractory Out of Hospital Cardiac Arrest Treated with Extracorporeal Life Support. Shock. 2018 Jan;49(1):24-28. doi: 10.1097/SHK.0000000000000941.

  PMID: 28682938 RESULT

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Antoine Kimmoun, MD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Kimmoun, MD

CONTACT

0033383154079; a.kimmoun@chru-nancy.fr

Tahar Chouied, MD

CONTACT

t.chouied@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, monocentric, open, routine care assessment study

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 24, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: November 24, 2017

Record last verified: 2017-11