Pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) for Refractory Cardiac ArrEst patients (PRE-CARE Study)
Pre-hospital ECPR for Refractory Cardiac ArrEst (PRE-CARE Study)
NSW Ambulance
50 participants
Aug 24, 2023
Interventional
Conditions
Summary
Out of hospital cardiac arrest (OHCA) is the leading cause of death in otherwise healthy adults affecting ~25,000 Australians per year. Even with conventional cardiopulmonary resuscitation (CCPR), survival decreases quickly. After 15 minutes of CCPR the arrest is deemed "refractory", the probability of good functional recovery falls 30 minutes <1% at 30mins. Extracorporeal membrane oxygenation (ECMO) is circulatory support technology. When ECMO is implemented during a cardiac arrest it is termed – Extracorporeal CardioPulmonary Resuscitation or ECPR. Currently, ECPR is implemented at a few large hospitals (5 in Sydney). The best outcomes with ECPR occur when the time from cardiac arrest to ECMO flow are minimised. Pre-hospital ECPR is implementing ECMO at the scene of cardiac arrest and reduces the time from cardiac arrest to ECMO flow. Pre-hospital ECPR services exist in Paris, London, Netherlands, Minnesota and New Mexico and is being trialled in Melbourne. The hypothesis for the trial is that compared with usual care (including hospital-based ECPR), scene-based ECPR is feasible and will increase the rate of neurologically intact survival at discharge in patients with refractory OHCA.
Eligibility
Inclusion Criteria9
- Adults over 18 years of age and under 65 years of age
- Witnessed cardiac arrest where no flow times can be reliably ascertained and bystander CPR (no flow time < 5 min)
- Refractory cardiac arrest: the failure of medical professionals to obtain sustained return of spontaneous circulation at the 15th minute of cardiac arrest with a minimum of 3 external defibrillator if indicated
- Shockable initial rhythm, with End-Tidal CO2 (ETCO2) > 10 mmHg at the time of inclusion
- PEA initial rhythm, if: signs of life during resuscitation (spontaneous movement, absence of mydriasis and/or pupillary response, spontaneous breathing movements) and: End-Tidal CO2 (ETCO2) >10 mmHg at the time of inclusion
- Suspected medical cause of the cardiac arrest (traumatic cardiac arrest is excluded)
- Drug overdoses with suspected cardiotoxic drugs
- Commencement of ECPR cannulation < 45min from time of cardiac arrest. or if >45min and <60min AND exhibiting signs of life during CPR
- Cardiac arrest was witnessed and ‘no flow’ times can be reliably ascertained
Exclusion Criteria5
- Initial rhythm asystole
- End-Tidal CO2 < 10 mmHg at the time of inclusion
- Pregnancy
- Duration > 5 minutes without cardiac massage after collapsing
- Co-morbidities that compromise the prognosis for short or medium-term survival.
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Interventions
Upon arrival of Extracorporeal Cardiopulmonary Resuscitation (ECPR) team (i.e. one critical care paramedic and two senior physicians in pre-hospital and retrieval medicine), participants will be assessed for eligibility according to pre-specified study inclusion and exclusion criteria and document this on a “STOP/GO” checklist. The senior physicians will administer once-off pre-hospital ECPR at scene of cardiac arrest to eligible participants using an ECMO machine. Briefly, the ECMO cannulae will be inserted and once percutaneous dilation and cannulation of the femoral vessels has commenced, the team will proceed to ECMO support in all circumstances. Once ECMO flow is established, the participant will be transported to hospital and receive standard of care treatment (including hospital ECPR and hospitalisation). Pre-hospital ECPR is ceased once hospital ECPR occurs. Non-eligible participants will continue to receive standard resuscitation per existing NSW Ambulance protocols. Participants will then receive standard of care treatment (including and hospitalisation).
Locations(3)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12625000318482