Cardiac Arrest Extra Corporeal Oxygenation Membrane

NCT ID: NCT03352999

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Arrest Cardiopulmonary Resuscitation Advanced Cardiac Life Support Extracorporeal Life Support

Keywords

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Refractory out-hospital cardiac arrest Extracorporeal Life Support

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, monocentric, open, routine care assessment study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ROHCA rescued by vaECMO

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

Group Type OTHER

Fast track access to vaECMO

Intervention Type 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.

Interventions

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Fast 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine Kimmoun, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Central Contacts

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Antoine Kimmoun, MD

Role: CONTACT

Phone: 0033383154079

Email: [email protected]

Tahar Chouied, MD

Role: CONTACT

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 28682938 (View on PubMed)

Other Identifiers

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2016-A01873-48.

Identifier Type: -

Identifier Source: org_study_id