Lars Wik1, Jan-Aage Olsen2, David Persse3, Fritz Sterz4, Michael Lozano5, Marc A Brouwer6, Mark Westfall7, Chris M Souders3, Reinhard Malzer8, Pierre M van Grunsven9, David T Travis10, Anne Whitehead11, Ulrich R Herken12, E Brooke Lerner13. 1. Norwegian Center for Prehospital Emergency Care, Oslo University Hospital, Oslo, Norway. Electronic address: lars.wik@medisin.uio.no. 2. Norwegian Center for Prehospital Emergency Care, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway. 3. Houston Fire Department and the Baylor College of Medicine, Houston, TX, United States. 4. Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria. 5. Hillsborough County Fire Rescue, Tampa, FL, United States; Department of Emergency Medicine, Lake Erie College, Bradenton, FL, United States. 6. Heart Lung Center, Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands. 7. Gold Cross Ambulance Service, Appleton Neenah-Menasha and Grand Chute Fire Departments, WI, United States; Theda Clark Regional Medical Center, Neenah, WI, United States. 8. Wiener Rettung, Municipal ambulance service of Vienna, Vienna, Austria. 9. Regional Ambulance Service Gelderland-Zuid, Nijmegen, The Netherlands. 10. Hillsborough County Fire Rescue, Tampa, FL, United States. 11. Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Fylde College, Lancaster University, Lancaster, United Kingdom. 12. ZOLL Medical Corporation, Chelmsford, MA, United States. 13. Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI, United States.
Abstract
OBJECTIVE: To compare integrated automated load distributing band CPR (iA-CPR) with high-quality manual CPR (M-CPR) to determine equivalence, superiority, or inferiority in survival to hospital discharge. METHODS: Between March 5, 2009 and January 11, 2011 a randomized, unblinded, controlled group sequential trial of adult out-of-hospital cardiac arrests of presumed cardiac origin was conducted at three US and two European sites. After EMS providers initiated manual compressions patients were randomized to receive either iA-CPR or M-CPR. Patient follow-up was until all patients were discharged alive or died. The primary outcome, survival to hospital discharge, was analyzed adjusting for covariates, (age, witnessed arrest, initial cardiac rhythm, enrollment site) and interim analyses. CPR quality and protocol adherence were monitored (CPR fraction) electronically throughout the trial. RESULTS:Of 4753 randomized patients, 522 (11.0%) met post enrollment exclusion criteria. Therefore, 2099 (49.6%) received iA-CPR and 2132 (50.4%) M-CPR. Sustained ROSC (emergency department admittance), 24h survival and hospital discharge (unknown for 12 cases) for iA-CPR compared to M-CPR were 600 (28.6%) vs. 689 (32.3%), 456 (21.8%) vs. 532 (25.0%), 196 (9.4%) vs. 233 (11.0%) patients, respectively. The adjusted odds ratio of survival to hospital discharge for iA-CPR compared to M-CPR, was 1.06 (95% CI 0.83-1.37), meeting the criteria for equivalence. The 20 min CPR fraction was 80.4% for iA-CPR and 80.2% for M-CPR. CONCLUSION: Compared to high-quality M-CPR, iA-CPR resulted in statistically equivalent survival to hospital discharge.
RCT Entities:
OBJECTIVE: To compare integrated automated load distributing band CPR (iA-CPR) with high-quality manual CPR (M-CPR) to determine equivalence, superiority, or inferiority in survival to hospital discharge. METHODS: Between March 5, 2009 and January 11, 2011 a randomized, unblinded, controlled group sequential trial of adult out-of-hospital cardiac arrests of presumed cardiac origin was conducted at three US and two European sites. After EMS providers initiated manual compressions patients were randomized to receive either iA-CPR or M-CPR. Patient follow-up was until all patients were discharged alive or died. The primary outcome, survival to hospital discharge, was analyzed adjusting for covariates, (age, witnessed arrest, initial cardiac rhythm, enrollment site) and interim analyses. CPR quality and protocol adherence were monitored (CPR fraction) electronically throughout the trial. RESULTS: Of 4753 randomized patients, 522 (11.0%) met post enrollment exclusion criteria. Therefore, 2099 (49.6%) received iA-CPR and 2132 (50.4%) M-CPR. Sustained ROSC (emergency department admittance), 24h survival and hospital discharge (unknown for 12 cases) for iA-CPR compared to M-CPR were 600 (28.6%) vs. 689 (32.3%), 456 (21.8%) vs. 532 (25.0%), 196 (9.4%) vs. 233 (11.0%) patients, respectively. The adjusted odds ratio of survival to hospital discharge for iA-CPR compared to M-CPR, was 1.06 (95% CI 0.83-1.37), meeting the criteria for equivalence. The 20 min CPR fraction was 80.4% for iA-CPR and 80.2% for M-CPR. CONCLUSION: Compared to high-quality M-CPR, iA-CPR resulted in statistically equivalent survival to hospital discharge.
Authors: F von Matthey; K F Braun; M Hanschen; F Pohlig; E C Schubert; E Matevossian; P Hoppmann; K-G Kanz; P Biberthaler Journal: Unfallchirurg Date: 2016-01 Impact factor: 1.000
Authors: Chi Keong Ching; Siew Hon Benjamin Leong; Siang Jin Terrance Chua; Swee Han Lim; Kenneth Heng; Sohil Pothiawala; Venkataraman Anantharaman Journal: Singapore Med J Date: 2017-07 Impact factor: 1.858
Authors: Venkataraman Anantharaman; Boon Lui Benjamin Ng; Shiang Hu Ang; Chun Yue Francis Lee; Siew Hon Benjamin Leong; Marcus Eng Hock Ong; Siang Jin Terrance Chua; Antony Charles Rabind; Nagaraj Baglody Anjali; Ying Hao Journal: Singapore Med J Date: 2017-07 Impact factor: 1.858