Cardiac Arrest Extra Corporeal Oxygenation Membrane

Not Applicable

• Conditions: Cardiopulmonary Resuscitation; Cardiac Arrest; Extracorporeal Life Support; Advanced Cardiac Life Support
• Interventions: Procedure: Fast track access to vaECMO

• Registration Number: NCT03352999
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-22
• Last Update Submitted: 2017-11-22
• Study First Posted: 2017-11-24
• Last Update Posted: 2017-11-24
• Study Start: 2017-12-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ROHCA rescued by vaECMO	Fast track access to vaECMO	Patients experiencing a ROHCA despite advanced CPR and finally rescued with a va ECMO device.

Primary Outcome Measures

Name	Time	Method
Number of survivors without neurological sequelae Number of survivors without neurological sequelae (DRS scale from 0 to 6)	1 year	Number of survivors without neurological sequelae (DRS scale from 0 to 6)

Secondary Outcome Measures

Name	Time	Method
Nosocomial complications	ECMO implantation - Day 1 - Day 3	bacteraemia
Bleeding complications	ECMO implantation - Day 1 - Day 3	bleeding
Number of survivors with or without neurological sequelae.	at 3 months	European quality of life scale EQ-5D at 3 months
Ischemia-reperfusion assessment	from ECMO implantation and day 3	Amount of fluid infused
Renal failure	ECMO implantation - Day 1- Day 3	Worst KDIGO stage
Hepatic failure	ECMO implantation - Day 1 - Day 3	Worst values of PT/bilirubin/ AST and ALT
Coagulation Failure	ECMO implantation- Day 1 - Day 3	platelets/PT/Fibrinogen
Quality of Resuscitation	from collapse to ECMO implantation (up to 60 minutes)	Total duration of the resuscitation: from collapse to ECMO implantation
Pupillary status	at arrival in intensive care - Hour 0 - Hour 6 - Hour 12 - Day 1	Pupillary status
Lactate	Hour 0 - Hour 6 - Hour 12 - Day 1	amount of Lactate
bispectral index	at arrival in intensive care - Hour 6 - Hour 12 - Day 1	bispectral index
Respiratory failure	ECMO implantation - Day 1- Day 3	PaO2/iFO2 value
Hemodynamic Failure	from ECMO implantation and day 3	Amount of Norepinephrine infused