The Sub30 Feasibility Trial
Research type
Research Study
Full title
The Sub30 feasibility study of a pre-hospital extra-corporeal membrane oxygenation (ECMO) capable advanced resuscitation team at achieving blood flow within 30 minutes of collapse in patients with refractory out-of-hospital cardiac arrest.
IRAS ID
244748
Contact name
Simon Finney
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary
Less than 10% of patients who have a cardiac arrest (their heart stopping) out-of-hospital survive to leave hospital. Many survivors have significant brain damage sustained whilst their heart was stopped. Conventional cardiopulmonary resuscitation (CCPR) includes chest compressions that produce some blood flow around the body, although much less than normal. A prolonged low blood flow state causes irreversible damage to a patient’s vital organs such as the brain. Extracorporeal Cardiopulmonary Resuscitation (ECPR) is a technique of temporarily replacing the function of the heart and lung even whilst the heart is stopped. During ECPR, a patient’s blood is pumped from tubes placed in the groin, through an artificial membrane lung and back to the patient. Since ECPR can nearly match normal blood flow, it may protect the brain and other vital organs from damage if the heart cannot be restarted quickly.
Observational studies show that the more rapid ECPR is associated with better survival without severe disability. Outcomes are particularly worse following delays of 60 minutes. If a patient suffers a cardiac arrest outside a hospital, then, despite a fast response, the initial resuscitation attempts on scene and subsequent transfer of a patient to an ambulance and hospital take time – such that patients rarely arrive at hospital before 60 minutes.
We plan to assess the feasibility and safety of a protocol that aims to establish ECPR in 6 patients within 30 minutes of the call to the emergency services by delivering ECPR at the scene of cardiac arrest (pre-hospital). A specifically trained team in a fast-response car will be dispatched by advanced paramedics to patients in cardiac arrest in North East London. If successful, this protocol will inform a larger study to determine whether pre-hospital ECPR can improve survival without severe disability in patients suffering out-of-hospital cardiac arrest.Summary of Results
Out of hospital ECMO could be delivered in a safe, timely and effective manner to patients in refractory cardiac arrest in a large metropolitan city. The average time to establishing full ECMO in this feasibility study was 47 minutes (range 37 to 59 minutes), longer than our target of below 30 minutes. Out of 5 patients, 2 survived to hospital discharge with a CPC score of 3 (severe cerebral disability).
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/0035
Date of REC Opinion
18 Feb 2019
REC opinion
Further Information Favourable Opinion