Out-Of-Hospital Cardiac Arrest Clinical Trial
— SUB30Official title:
Feasibility Study of a Pre-hospital Extra-corporeal Membrane Oxygenation (ECMO) Capable Advanced Resuscitation Team at Achieving Blood Flow Within 30 Minutes in Patients With Refractory Cardiac Arrest.
Verified date | November 2020 |
Source | Barts & The London NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To establish whether a pre-hospital advanced physician/ paramedic cardiac arrest team that is ECMO capable can establish ECMO flow within 30 minutes of collapse. The Sub30 study will investigate the technical and logistical feasibility of instituting pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) within 30 minutes of collapse for selected patients (n=6) in a geographical sector of Greater London. It will achieve this through a unique collaboration between the primary emergency dispatch and response services (London Ambulance Service NHS Trust, LAS), pre-hospital practitioners (LAS and London Air Ambulance) and clinicians in ECMO (Barts Health NHS Trust).
Status | Active, not recruiting |
Enrollment | 6 |
Est. completion date | December 31, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Adult patients who: - have a witnessed out-of-hospital cardiac arrest - a presumed cardiac aetiology to their cardiac arrest - receive bystander chest compressions within 3 minutes - remain in cardiac arrest at 20 minutes following the call to the emergency services or fail to sustain ROSC in the pre-hospital setting Exclusion Criteria: The following patients will not be suitable for entry into the study: - Known to be are visibly appear younger than 18 years old or older than 65 years. - Known or visible advanced pregnancy (when resuscitative hysterotomy should be performed) - No signs of life (physical movement or breathing) AND evidence of ineffective chest compressions suggested by: - absence of electrical activity at 20 minutes time out OR - end tidal carbon dioxide level of less than 1.3 kPa (10 mmHg) - Evidence from others present at the scene or patient examination that ECMO unlikely to benefit patient (e.g. advanced malignancy, severe frailty). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | London Ambulance Service Trust | London | |
United Kingdom | St Bartholomew's Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Barts & The London NHS Trust | Bodychillz Ltd, London's Air Ambulance, Maquet Cardiopulmonary GmbH, Stryker Nordic |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients successfully established with pre-hospital ECPR | The primary endpoint is the proportion of patients successfully established with pre-hospital ECPR within 30 minutes of collapse | Within 30 minutes of collapse | |
Secondary | Ambulance dispatch | Number of patients not dispatched to as travel time too great/team unavailable | Within 30 minutes of collapse | |
Secondary | Successful cannulation | The number of patients successfully cannulated 31 and 45 minutes | between 31 and 45 minutes; and 46 and 60 minutes. | |
Secondary | Number of patients with return of spontaneous circulations (ROSC) | The number of patients patients who achieve ROSC prior to the 20 minutes timeout, number of patients in refractory cardiac arrest at 20 minutes in whom ROSC is achieved prior to ECMO flow | Within 20 minutes of cardiac arrest | |
Secondary | Emergency call-out time frame | The time interval between call to the emergency services and ECPR team arrival | At 30 minutes after cardiac arrest | |
Secondary | Successful guide wire placement | The proportion of potentially supportable patients in whom guidewire placement is attempted and achieved | Up to 30 minutes after cardiac arrest | |
Secondary | Incidence of ECPR-related complications | Assessment of ECPR-related complications, such as incidence of vascular damage, haemorrhage requiring transfusion and new organ dysfunction | Duration of ECMO run, between 3 - 14 days | |
Secondary | Clinical outcome via FIM at 3 months | Assessment of functional status at hospital discharge using the Functional Independence Measure - FIM (18 item scale, measure of dependence. The higher the score, the more independent the patient is in performing the task). | 3 months | |
Secondary | Clinical outcome via MRS at 3 months | Assessment of functional status at hospital discharge using the modified Rankin Scale (MRS) (scale 0-6, measuring the degree of disability or dependence in the daily activities, where 0 is no symptoms and 6 is dead) | 3 months | |
Secondary | Duration of hospital stay | Assessment of health resources used for the duration of Intensive Care Unit stay | 1-3 months | |
Secondary | Number of acute hospital admissions post discharge | Assessment of health resources used for further hospital admissions following discharge. | 3 months |
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