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Manual vs. integrated automatic load-distributing band CPR with equal survival after out of hospital cardiac arrest. The randomized CIRC trial
Authors:Lars Wik  Jan-Aage Olsen  David Persse  Fritz Sterz  Michael Lozano Jr.  Marc A. Brouwer  Mark Westfall  Chris M. Souders  Reinhard Malzer  Pierre M. van Grunsven  David T. Travis  Anne Whitehead  Ulrich R. Herken  E. Brooke Lerner
Affiliation:1. Norwegian Center for Prehospital Emergency Care, Oslo University Hospital, Oslo, Norway;2. 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;6. Department of Emergency Medicine, Lake Erie College, Bradenton, FL, United States;g Heart Lung Center, Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands;h Gold Cross Ambulance Service, Appleton Neenah-Menasha and Grand Chute Fire Departments, WI, United States;i Theda Clark Regional Medical Center, Neenah, WI, United States;j Wiener Rettung, Municipal ambulance service of Vienna, Vienna, Austria;k Regional Ambulance Service Gelderland-Zuid, Nijmegen, The Netherlands;l Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Fylde College, Lancaster University, Lancaster, United Kingdom;m ZOLL Medical Corporation, Chelmsford, MA, United States;n 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), 24 h 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.
Keywords:Cardiac arrest   Cardiopulmonary resuscitation   Survival   Load distributing band
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