Keith Couper1, Tom Quinn2, Katie Booth3, Ranjit Lall3, Anne Devrell4, Barry Orriss4, Scott Regan3, Joyce Yeung5, Gavin D Perkins5. 1. Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. Electronic address: k.couper@warwick.ac.uk. 2. Emergency, Cardiovascular and Critical Care Research Group, Faculty of Health, Social Care and Education, Kingston University, London and St George's, University of London, London, UK. 3. Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK. 4. Patient Research Ambassador. 5. Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Abstract
BACKGROUND:Mechanical chest compression devices deliver high-quality chest compressions. Early data suggests that mechanical devices may be superior to manual chest compressions in adults following an in-hospital cardiac arrest patients. To determine the feasibility of undertaking an effectiveness trial in this population, we undertook a feasibility randomised controlled trial. METHODS: We undertook a multi-centre parallel group feasibility randomised controlled trial (COMPRESS-RCT). Adult in-hospital cardiac arrest patients that were in a non-shockable rhythm were randomised in a 3:1 ratio to receive mechanical CPR (Jolfe AB/Stryker, Lund, Sweden) or ongoing manual CPR. Recruitment was led by the clinical cardiac arrest team. The primary study outcome was the proportion of eligible participants randomised in the study during site operational recruitment hours. Patients were enrolled under a model of deferred consent. We report data using descriptive statistics, point estimates and 95% confidence intervals. RESULTS: Over a two-year period, we recruited 127 patients across five UK hospitals. We recruited 55.2% (95% CI 48.5%-61.8%) of eligible study participants in site operational recruitment hours. Most participants were male (n = 76, 59.8%) with a mean age of 72 (95% CI: 69.9-74.9) years. Median arrest duration was 18 (IQR 13-29) minutes. In patients randomised to mech-CPR, median time from CPR start to device deployment was 11 (IQR 7-15) minutes. ROSC was achieved in 27.6% (n = 35) participants and 4.7% (n = 6) were alive at 30-days. CONCLUSION: COMPRESS-RCT identified important factors that preclude progression to an effectiveness trial of mechanical CPR in the hospital setting in the UK. Findings will inform the design of future in-hospital intra-arrest intervention trials. ISRCTN38139840, date of registration 9th January 2017.
RCT Entities:
BACKGROUND: Mechanical chest compression devices deliver high-quality chest compressions. Early data suggests that mechanical devices may be superior to manual chest compressions in adults following an in-hospital cardiac arrestpatients. To determine the feasibility of undertaking an effectiveness trial in this population, we undertook a feasibility randomised controlled trial. METHODS: We undertook a multi-centre parallel group feasibility randomised controlled trial (COMPRESS-RCT). Adult in-hospital cardiac arrestpatients that were in a non-shockable rhythm were randomised in a 3:1 ratio to receive mechanical CPR (Jolfe AB/Stryker, Lund, Sweden) or ongoing manual CPR. Recruitment was led by the clinical cardiac arrest team. The primary study outcome was the proportion of eligible participants randomised in the study during site operational recruitment hours. Patients were enrolled under a model of deferred consent. We report data using descriptive statistics, point estimates and 95% confidence intervals. RESULTS: Over a two-year period, we recruited 127 patients across five UK hospitals. We recruited 55.2% (95% CI 48.5%-61.8%) of eligible study participants in site operational recruitment hours. Most participants were male (n = 76, 59.8%) with a mean age of 72 (95% CI: 69.9-74.9) years. Median arrest duration was 18 (IQR 13-29) minutes. In patients randomised to mech-CPR, median time from CPR start to device deployment was 11 (IQR 7-15) minutes. ROSC was achieved in 27.6% (n = 35) participants and 4.7% (n = 6) were alive at 30-days. CONCLUSION: COMPRESS-RCT identified important factors that preclude progression to an effectiveness trial of mechanical CPR in the hospital setting in the UK. Findings will inform the design of future in-hospital intra-arrest intervention trials. ISRCTN38139840, date of registration 9th January 2017.