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Clinical Trial
. 2024 Apr 17;32(1):31.
doi: 10.1186/s13049-024-01198-x.

A national multi centre pre-hospital ECPR stepped wedge study; design and rationale of the ON-SCENE study

Samir Ali  1   2   3 , Xavier Moors  4   5 , Hans van Schuppen  6 , Lars Mommers  7   8 , Ellen Weelink  9 , Christiaan L Meuwese  10 , Merijn Kant  11 , Judith van den Brule  12 , Carlos Elzo Kraemer  13 , Alexander P J Vlaar  14 , Sakir Akin  15 , Annemiek Oude Lansink-Hartgring  16 , Erik Scholten  17 , Luuk Otterspoor  18 , Jesse de Metz  19 , Thijs Delnoij  20 , Esther M M van Lieshout  21 , Robert-Jan Houmes  5 , Dennis den Hartog  21 , Diederik Gommers  10 , Dinis Dos Reis Miranda  10   5
Affiliations
Clinical Trial

A national multi centre pre-hospital ECPR stepped wedge study; design and rationale of the ON-SCENE study

Samir Ali et al. Scand J Trauma Resusc Emerg Med. .

Abstract

Background: The likelihood of return of spontaneous circulation with conventional advanced life support is known to have an exponential decline and therefore neurological outcome after 20 min in patients with a cardiac arrest is poor. Initiation of venoarterial ExtraCorporeal Membrane Oxygenation (ECMO) during resuscitation might improve outcomes if used in time and in a selected patient category. However, previous studies have failed to significantly reduce the time from cardiac arrest to ECMO flow to less than 60 min. We hypothesize that the initiation of Extracorporeal Cardiopulmonary Resuscitation (ECPR) by a Helicopter Emergency Medical Services System (HEMS) will reduce the low flow time and improve outcomes in refractory Out of Hospital Cardiac Arrest (OHCA) patients.

Methods: The ON-SCENE study will use a non-randomised stepped wedge design to implement ECPR in patients with witnessed OHCA between the ages of 18-50 years old, with an initial presentation of shockable rhythm or pulseless electrical activity with a high suspicion of pulmonary embolism, lasting more than 20, but less than 45 min. Patients will be treated by the ambulance crew and HEMS with prehospital ECPR capabilities and will be compared with treatment by ambulance crew and HEMS without prehospital ECPR capabilities. The primary outcome measure will be survival at hospital discharge. The secondary outcome measure will be good neurological outcome defined as a cerebral performance categories scale score of 1 or 2 at 6 and 12 months.

Discussion: The ON-SCENE study focuses on initiating ECPR at the scene of OHCA using HEMS. The current in-hospital ECPR for OHCA obstacles encompassing low survival rates in refractory arrests, extended low-flow durations during transportation, and the critical time sensitivity of initiating ECPR, which could potentially be addressed through the implementation of the HEMS system. When successful, implementing on-scene ECPR could significantly enhance survival rates and minimize neurological impairment.

Trial registration: Clinicaltyrials.gov under NCT04620070, registration date 3 November 2020.

Keywords: Advanced cardiac life support; Cardiopulmonary resuscitation; Extracorporeal membrane oxygenation; Out-of-hospital cardiac arrest.

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Conflict of interest statement

D. Dos Reis Miranda received speaking fee from Getinge Netherlands. The rest of the authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The 10 ECPR centres with their 30 min radius
Fig. 2
Fig. 2
HEMS Region with their 20 min geographic radius. HEMS: Helicopter Emergency Medical Services
Fig. 3
Fig. 3
Schematic timetable of the stepped-wedge study design. ECPR experienced personnel and non-ECPR experienced personnel). HEMS: Helicopter Emergency Medical Service. CCPR: HEMS operating without ECMO: Conventional CardioPuImonary Resuscitation. ECPR: HEMS operating with ECMO: Extra-Corporeal CardioPulmonary Resuscitation Training: Timing training of HEMS personnel
See this image and copyright information in PMC

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