Specialty: Cardiovascular disease, Primary sub-specialty: Heart Failure
Conditions
Interventions
Participants are randomised in a 3:1 ratio to receive either mechanical chest compressions or manual chest compressions. Randomisation will be done by opening an opaque envelope that is kept with the
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sustain an in-hospital cardiac arrest and resuscitation is attempted by a hospital cardiac arrest team trained in the use of the mechanical chest compression device 2. In a non-shockable rhythm (pulseless electrical activity or asystole) at the time of eligibility assessment 3. Known or believed to be aged 18 years or over
Exclusion criteria
Exclusion criteria: 1. Patient has valid do not attempt cardiopulmonary resuscitation order 2. Known or clinically apparent pregnancy 3. Cardiac arrest where use of a mechanical chest compression device is contra-indicated (e.g. following cardiac surgery, thoracic trauma, patient size) 4. Known previous study participation 5. Patient requiring use of mechanical chest compression device as part of routine clinical care 6. Patient known to be detained by Her Majesty’s Prison Service
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current Primary outcome measure, as of 21/03/2018: Proportion of eligible patients that are randomised during operational recruitment hours over the entire study period. Previous Primary outcome measure: Proportion of eligible participants randomised over the entire study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility outcome measures: 1. Proportion of patients randomised outside of weekday daytime hours is assessed at the end of the study 2. Device deployment time (compression pause associated with device deployment) is assessed at the end of the study 3. Proportion of patients/consultees agreeing to ongoing study participation is assessed at the end of the study 4. Success of study blinding procedures is assessed at the end of the study 5. Proportion of patients with complete follow-up data is assessed at the end of the study 6. Proportion of patients with analysable chest compression quality data is assessed at the end of the study Patient outcome measures: 1. Return of spontaneous circulation is assessed by reviewing patient notes 20 minutes following cardiac arrest 2. Survival is assessed by reviewing patient notes at hospital discharge, 30 days and 6 months 3. Neurological outcome is assessed using the cerebral performance category at discharge and modified rankin score at discharge and 6 months 4. Hospital/critical care length of stay is measured by reviewing patient notes at the time of discharge 5. Quality of life is measured using the EQ-5D and SF-12 at discharge and 6 months Process outcome measure: CPR quality (rate, depth, flow-fraction, pauses- pre-,post-, peri-shock) is assessed by reviewing defibrillator and/ or mechanical device data during cardiac arrest. Safety outcome measure: Device related adverse events are measured by reviewing patient notes up to the point of discharge | — |
Countries
United Kingdom
Contacts
Public ContactKeith Couper
Outcome results
None listed