Out of hospital cardiac arrest Circulatory System
Conditions
Interventions
Intervention arm:
The Impedance Threshold Device (ITD) (ResQPODTM
ZOLL Medical Corp. and Advanced Circulatory Systems, Inc.) will be attached immediately after rhythm check and defibrillation if the presenting rhythm is ventricular fibrillation (VF) or ventricular t
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 or older with an unexpected cardiorespiratory arrest 2. Primary cardiac origin was suspected, in the absence of trauma, known terminal illness or other external cause such as self-harm 3. Resuscitation attempt in accordance with normal NEAS policy
Exclusion criteria
Exclusion criteria: 1. Age 17 or under 2. Do Not Attempt Resuscitation decision 3. NEAS Recognition of Life Extinct policy applied 4. ROSC prior to use of device 5. Pregnant, known or clinically suspected 6. Suspected non-cardiac origin 7. Trauma, suicide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pilot will assess that the study design, including if the training given to paramedics results in high rates of recruitment and whether compliance with treatment allocations is in accordance with the randomisation schedule. It will also be used to inform the sample size calculation for the larger trial and to determine likely recruitment rates. The assessment will include: 1. The correct operation of equipment and whether the control device truly results in investigator blinding, assessed using Clinical Paramedic Feedback at 0-1 weeks 2. The reliability and validity of systems of data capture for each of the likely end points of the definitive RCT, measured by cross-referencing NEAS cardiac arrest database with paramedic feedback, including electronic Patient Report Form (ePRF data) at 0-6 weeks 3. The effectiveness of systems for identifying and reporting adverse effects, measured by paramedic feedback and liaison with name hospital collaborators on outcome at 0-26 weeks 4. Endpoints for the definitive RCT, measured by assessing the outcome data in the pilot with regards to quality and access to clinical data and ease of survivor follow-up. This will occur between 12-24 months 5. Determination of the numbers required in a larger, definitive RCT and likely recruitment rates, measured using 12-month survival rates used to perform a sample size calculation. This will be performed between 12-24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Survival to discharge, collected by proforma using the Utstein criteria or routine clinical data collection through the ambulance Patient Report Forms (PRFs) at 12-24 months 2. Return of spontaneous circulation (ROSC) pre-hospital, collected by proforma using the Utstein criteria or routine clinical data collection through the ambulance Patient Report Forms (PRFs) at 12-24 months 3. Survival to Emergency Departmen, collected by proforma using the Utstein criteria or routine clinical data collection through the ambulance Patient Report Forms (PRFs) at 12-24 months 4. Survival to hospital discharge, neurologically intact, collected using the Utstein criteria or routine clinical data collection through collaboration with secondary care contacts at 12-24 months 5. 30-day and 12-month survival, neurologically intact, collected from the NHS Central Register for England and Wales at 12-24 months | — |
Countries
United Kingdom
Outcome results
None listed