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出境医 / 临床实验 / Pre-hospital ECMO in Advanced Resuscitation in Patients With Refractory Cardiac Arrest. ( SUB30 ) (SUB30)

Pre-hospital ECMO in Advanced Resuscitation in Patients With Refractory Cardiac Arrest. ( SUB30 ) (SUB30)

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Death, Sudden, Cardiac Out-Of-Hospital Cardiac Arrest Ventricular Fibrillation Cardiopulmonary Arrest With Successful Resuscitation Procedure: ECMO resuscitation Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single centre feasibility study of a complex intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: ECMO resuscitation
6 patients who meet the eligibility criteria will be treated by pre-hospital advanced physician/ paramedic cardiac arrest team that is ECMO capable and can establish ECMO flow within 30 minutes of collapse
Procedure: ECMO resuscitation
Extracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest
Other Name: Extracorporeal Membrane Oxygenation

Outcome Measures
Primary Outcome Measures :
  1. Proportion of patients successfully established with pre-hospital ECPR [ Time Frame: Within 30 minutes of collapse ]
    The primary endpoint is the proportion of patients successfully established with pre-hospital ECPR within 30 minutes of collapse


Secondary Outcome Measures :
  1. Ambulance dispatch [ Time Frame: Within 30 minutes of collapse ]
    Number of patients not dispatched to as travel time too great/team unavailable

  2. Successful cannulation [ Time Frame: between 31 and 45 minutes; and 46 and 60 minutes. ]
    The number of patients successfully cannulated 31 and 45 minutes

  3. Number of patients with return of spontaneous circulations (ROSC) [ Time Frame: Within 20 minutes of cardiac arrest ]
    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

  4. Emergency call-out time frame [ Time Frame: At 30 minutes after cardiac arrest ]
    The time interval between call to the emergency services and ECPR team arrival

  5. Successful guide wire placement [ Time Frame: Up to 30 minutes after cardiac arrest ]
    The proportion of potentially supportable patients in whom guidewire placement is attempted and achieved

  6. Incidence of ECPR-related complications [ Time Frame: Duration of ECMO run, between 3 - 14 days ]
    Assessment of ECPR-related complications, such as incidence of vascular damage, haemorrhage requiring transfusion and new organ dysfunction

  7. Clinical outcome via FIM at 3 months [ Time Frame: 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).

  8. Clinical outcome via MRS at 3 months [ Time Frame: 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)

  9. Duration of hospital stay [ Time Frame: 1-3 months ]
    Assessment of health resources used for the duration of Intensive Care Unit stay

  10. Number of acute hospital admissions post discharge [ Time Frame: 3 months ]
    Assessment of health resources used for further hospital admissions following discharge.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations

Locations
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United Kingdom
St Bartholomew's Hospital
London, United Kingdom, EC1 6BQ
London Ambulance Service Trust
London, United Kingdom, SE1 0BW
Sponsors and Collaborators
Barts & The London NHS Trust
London's Air Ambulance
Bodychillz Ltd
Maquet Cardiopulmonary GmbH
Stryker Nordic
Investigators
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Principal Investigator: Simon Finney Barts & The London NHS Trust
Tracking Information
First Submitted Date  ICMJE October 2, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE September 23, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
Proportion of patients successfully established with pre-hospital ECPR [ Time Frame: Within 30 minutes of collapse ]
The primary endpoint is the proportion of patients successfully established with pre-hospital ECPR within 30 minutes of collapse
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
  • Ambulance dispatch [ Time Frame: Within 30 minutes of collapse ]
    Number of patients not dispatched to as travel time too great/team unavailable
  • Successful cannulation [ Time Frame: between 31 and 45 minutes; and 46 and 60 minutes. ]
    The number of patients successfully cannulated 31 and 45 minutes
  • Number of patients with return of spontaneous circulations (ROSC) [ Time Frame: Within 20 minutes of cardiac arrest ]
    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
  • Emergency call-out time frame [ Time Frame: At 30 minutes after cardiac arrest ]
    The time interval between call to the emergency services and ECPR team arrival
  • Successful guide wire placement [ Time Frame: Up to 30 minutes after cardiac arrest ]
    The proportion of potentially supportable patients in whom guidewire placement is attempted and achieved
  • Incidence of ECPR-related complications [ Time Frame: Duration of ECMO run, between 3 - 14 days ]
    Assessment of ECPR-related complications, such as incidence of vascular damage, haemorrhage requiring transfusion and new organ dysfunction
  • Clinical outcome via FIM at 3 months [ Time Frame: 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).
  • Clinical outcome via MRS at 3 months [ Time Frame: 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)
  • Duration of hospital stay [ Time Frame: 1-3 months ]
    Assessment of health resources used for the duration of Intensive Care Unit stay
  • Number of acute hospital admissions post discharge [ Time Frame: 3 months ]
    Assessment of health resources used for further hospital admissions following discharge.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre-hospital ECMO in Advanced Resuscitation in Patients With Refractory Cardiac Arrest. ( SUB30 )
Official Title  ICMJE 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.
Brief Summary 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).
Detailed Description

Every year, in London, the ambulance service treats over 4,000 patients who have a had a cardiac arrest (or their heart has stopped). Less than 1 in 10 patients survive to get home. Some of those who survive have severe brain damage since their brains did not receive blood and oxygen when their heart was stopped. The ambulance service in London manages to get to a patient, on average, 7 minutes following a 999 call. The paramedics are very skilled in restarting people's hearts and often manage this in less than 10 minutes. However, sometimes it can take much longer or not be possible. The risks of a patient dying or suffering brain damage increase the longer it takes to restart the heart, particularly after about 20-30 minutes. An extracorporeal membrane oxygenation (ECMO) machine may reduce these risks by pumping a patient's blood through an artificial lung and to their vital body organs - temporarily replacing the function of the heart and lungs. The ECMO is used in normal care to support patients after a cardiac arrest once a patient reaches the hospital, but in this study we want to see if the ECMO can be used very soon after the cardiac arrest is reported via the 999 call.

In the Sub30 study, the ECMO team and machine to travel immediately to where the patient collapses rather than wait for the patient to be moved to a hospital. The study hypothesis is that the ECMO will be started faster and that this may improve patient survival and outcomes.

The ECMO team consists of three senior doctors and a paramedic. They attend patients who have collapsed and start ECMO if standard advanced resuscitation techniques fail to restart the heart in 20 minutes. The team will aim to have the ECMO machine started within 30 minutes of the 999 call. The team have achieved this in training and the current study will assess whether it is possible to do this in six patients in real-life.

A target of thirty minutes to achieve ECMO flow or return of spontaneous circulation (ROSC) is less than in published series to date. This can be achieved by:

  • integration into an established pre-hospital emergency response services that aggressively pursue ROSC through optimised Advanced Life Support
  • immediate deployment of an ECPR-capable cardiac arrest team as a primary resource, as opposed to delayed secondary deployment. Dispatch will be done by the established Advanced Paramedic Practitioner (APP) desk of London Ambulance Service, with the objective to reach the patient within 8-10 minutes of the 999 call.
  • early placement of guide-wires into the femoral vessels during on-going conventional CPR, a procedure with low complication risk that does not commit the team to ECPR but will minimise the delay to ECPR support if conventional resuscitative techniques are not successful within 20 minutes
  • facilitated guide-wire placement through real-time wireless ultrasound delivered to the operator through augmented reality smart glasses.

Some out of hospital cardiac arrests (OHCA) are irreversible in nature and ECPR would not provide benefit to these patients. The ECPR team will not be task fixated on providing ECPR, but also supportive of the APP primary responders and provide ECPR only in settings of refractory cardiac arrest that fulfils the study criteria, that have been chosen based on best available evidence to identify those patients in whom ECPR is likely to be of benefit.

If pre-hospital ECMO is feasible within 30 minutes of chest compressions starting, then a larger randomised controlled study of clinical and cost effectiveness is merited. Optimisation of the delivery of ECPR is vital, prior to a controlled study, in order to maximise any potential benefits for patients.

Data from Sub30 will inform the design of such studies enabling an estimation of the size of any potential outcome benefits and the likely affordability for a healthcare service.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single centre feasibility study of a complex intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Death, Sudden, Cardiac
  • Out-Of-Hospital Cardiac Arrest
  • Ventricular Fibrillation
  • Cardiopulmonary Arrest With Successful Resuscitation
Intervention  ICMJE Procedure: ECMO resuscitation
Extracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest
Other Name: Extracorporeal Membrane Oxygenation
Study Arms  ICMJE Experimental: ECMO resuscitation
6 patients who meet the eligibility criteria will be treated by pre-hospital advanced physician/ paramedic cardiac arrest team that is ECMO capable and can establish ECMO flow within 30 minutes of collapse
Intervention: Procedure: ECMO resuscitation
Publications * Singer B, Reynolds JC, Davies GE, Wrigley F, Whitbread M, Faulkner M, O'Brien B, Proudfoot AG, Mathur A, Evens T, Field J, Monk V, Finney SJ; International ECMO Network (ECMONet). Sub30: Protocol for the Sub30 feasibility study of a pre-hospital Extracorporeal membrane oxygenation (ECMO) capable advanced resuscitation team at achieving blood flow within 30 min in patients with refractory out-of-hospital cardiac arrest. Resusc Plus. 2020 Dec;4:100029. doi: 10.1016/j.resplu.2020.100029. Epub 2020 Oct 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 8, 2018)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03700125
Other Study ID Numbers  ICMJE 012543
244748 ( Other Identifier: IRAS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share study participant data
Responsible Party Barts & The London NHS Trust
Study Sponsor  ICMJE Barts & The London NHS Trust
Collaborators  ICMJE
  • London's Air Ambulance
  • Bodychillz Ltd
  • Maquet Cardiopulmonary GmbH
  • Stryker Nordic
Investigators  ICMJE
Principal Investigator: Simon Finney Barts & The London NHS Trust
PRS Account Barts & The London NHS Trust
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP