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.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Introduction An 80% chest compression fraction (CCF) during resuscitation is recommended. However, heterogeneous results in CCF studies were found during the 2015 Consensus on Science (CoS), ...which may be because chest compressions are stopped for a wide variety of reasons including providing lifesaving care, provider distraction, fatigue, confusion, and inability to perform lifesaving skills efficiently. Objective The effect of confounding variables on CCF to predict cardiac arrest survival. Methods A secondary analysis of emergency medical services (EMS) treated out-of-hospital cardiac arrest (OHCA) patients who received manual compressions. CCF (percent of time patients received compressions) was determined from electronic defibrillator files. Two Sample Wilcoxon Rank Sum or regression determined a statistical association between CCF and age, gender, bystander CPR, public location, witnessed arrest, shockable rhythm, resuscitation duration, study site, and number of shocks. Univariate and multivariate logistic regressions were used to determine CCF effect on survival. Results Of 2132 patients with manual compressions 1997 had complete data. Shockable rhythm ( p < 0.001), public location ( p < 0.004), treatment duration ( p < 0.001), and number of shocks ( p < 0.001) were associated with lower CCF. Univariate logistic regression found that CCF was inversely associated with survival (OR 0.07; 95% CI 0.01–0.36). Multivariate regression controlling for factors associated with survival and/or CCF found that increasing CCF was associated with survival (OR 6.34; 95% CI 1.02–39.5). Conclusion CCF cannot be looked at in isolation as a predictor of survival, but in the context of other resuscitation activities. When controlling for the effects of other resuscitation activities, a higher CCF is predictive of survival. This may explain the heterogeneity of findings during the CoS review.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Purpose Mechanical chest compression devices, such as the AutoPulse® , have been developed to overcome problems associated with manual CPR (M-CPR). Animal and human studies have shown that ...AutoPulse CPR improves hemodynamic parameters over M-CPR. However, human studies conducted in the prehospital setting have conflicting results as to the AutoPulse's efficacy in improving survival. The Circulation Improving Resuscitation Care (CIRC) Trial is designed to evaluate the effectiveness of integrated AutoPulse-CPR (iA-CPR) (i.e., M-CPR followed by AutoPulse® -CPR) in a randomized controlled trial that addresses methodological issues that may have influenced the results of previous studies. Methods This paper describes the methodology of the CIRC trial. Results Unlike previous trials the CIRC trial studies iA-CPR where emphasis is placed on reducing “hands-off” time. The trial has six unique features: (1) training of all EMS providers in a standardized deployment strategy that reduces hands-off time and continuous monitoring for protocol compliance. (2) A pre-trial simulation study of provider compliance with the trial protocol. (3) Three distinct study phases (in-field training, run-in, and statistical inclusion) to minimize the Hawthorne effect and other biases. (4) Monitoring of the CPR process using either transthoracic impedance or accelerometer data. (5) Randomization at the subject level after the decision to resuscitate is made to reduce selection bias. (6) Use of the Group Sequential Double Triangular Test with sufficient power to determine superiority, inferiority, or equivalence. Conclusion This unique, large, multicenter study comparing the effectiveness of iA-CPR to M-CPR will contribute to the science of the treatment of out-of-hospital cardiac arrest as well as to the design of future trials.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background
Mild therapeutic hypothermia is argued being beneficial for outcome after cardiac arrest.
Materials and methods
Retrospective analysis of Circulation Improving Resuscitation Care (CIRC) ...trial data to assess if therapeutic cooling to 33 ± 1 °C core temperature had an association with survival. Of 4231 adult, out‐of‐hospital cardiac arrests of presumed cardiac origin initially enrolled, eligibility criteria for therapeutic hypothermia were met by 1812. Logistic regression was undertaken in a stepwise fashion to account for the impact on outcome of each significant difference and for the variable of interest between the groups.
Results
Out‐of‐ and in‐hospital cooled were 263 (15%), only after admission cooled were 230 (13%) and not cooled were 357 (20%) patients. The group cooled out of‐ and in hospital had 98 (37%) survivors as compared to the groups cooled in hospital only 80 (35%) and of those not cooled 68 (19%). After adjusting for known covariates (sex, age, witnessed cardiac arrest, no‐ and low‐flow time, shockable initial rhythm, random allocation, bystander cardiopulmonary resuscitation and percutaneous coronary intervention), the odds ratio for survival comparing no cooling to out‐of‐ plus in‐hospital cooling was 0·53 95% confidence interval (CI): 0·46–0·61, P < 0·001, and comparing to in‐hospital cooling only was 0·67 (95% CI: 0·50–0·89, P = 0·006).
Conclusion
Mild therapeutic hypothermia initiated out of hospital and/or in hospital was associated with improved survival within this secondary analysis of the CIRC cohort compared to no therapeutic hypothermia.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK
Abstract only Background: The Circulation Improving Resuscitation Care (CIRC) Trial found equivalent survival in out-of-hospital cardiac arrest (OHCA) patients who received integrated AutoPulse CPR ...(iA-CPR) compared to high quality Manual CPR (M-CPR), and no difference in neurologic outcome. However, neurologic outcome was not available for some patients, and discharge location may serve as a proxy for neurologic outcome. The objective of this study was to determine if there is a correlation between modified Rankin Scale (mRS) Score at discharge and discharge location, and to determine the association between discharge location and study intervention. Methods: A subgroup-analysis of the CIRC randomized clinical trial comparing iA-CPR to M-CPR was conducted on patients who were discharged from hospital. Neurologic outcome was categorized as good (mRS ≤3), not good (mRS ≥4), or unknown, and according to discharge location of home or rehabilitation, nursing home or assisted living, and unknown or awaiting care, respectively. Spearman correlation was used to determine the relationship between mRS score and discharge location. Logistic Regression was used to compare iA-CPR to M-CPR in predicting neurologic outcome using discharge location and adjusting for the study covariates (study site, patient age, witnessed arrest, and initial rhythm). Results: CIRC enrolled 4,231 patients and 429 (10%) survived to hospital discharge. mRS score was known for 310 of those patients and discharge location for 300 patients, both were known for 292. A Spearman correlation analysis between mRS score and discharge location was statistically significant (r=0.622, p<0.001). iA-CPR was documented to increase survival to hospital discharge with good neurologic outcome (using discharge location as a surrogate) compared to M-CPR (unadjusted OR 2.25, 95% CI 1.21-4.17, p=0.009). When adjusted for covariates there was a trend in favor of iA-CPR (OR 1.82, 95% CI 0.91-3.63, p=0.09). Conclusion: There was a correlation between mRS score and discharge location. More patients were discharged to a location with limited assistance and consequently potential better neurologic outcome in the iA-CPR group compared to the high quality M-CPR group.
Abstract only Background: Deployment of mechanical chest compression devices is suspected to increase hands-off fraction. A potential benefit of mechanical devices is defibrillation during ...compressions, but it is unknown if this is utilized in the field. Our objectives were to compare hands-off fraction between manual CPR (M-CPR) and integrated AutoPulse CPR (iA-CPR), and to determine if providers will defibrillate during mechanical compressions. Methods: An international randomized clinical trial of EMS treated adult cardiac arrests of cardiac origin was conducted at 5 sites from March 2009 to January 2011. All EMS providers received 4 hours of training in providing high quality CPR and AutoPulse deployment. After initial manual compressions, patients were randomized to iA-CPR or M-CPR. ECG and impedance or accelerometer data were analyzed to determine the number of compressions per minute, and hands-off fraction was calculated at 10 and 20 minutes. Descriptive statistics and 95% CI were calculated. Results: A total of 4,232 subjects were enrolled. Electronic data were available for 4,135 (98%) cases (2,055 M-CPR, 2,080 iA-CPR). There were 117 (3%) cases with no compression data (69 M-CPR, 48 iA-CPR). There were more compressions per minute in the M-CPR arm (table). The mean hands-off fraction at 10 minutes was 20.4% M-CPR and 21.5% iA-CPR (difference 1.1%; 95% CI 0.5% to 1.7%) and at 20 minutes was 20.2% M-CPR and 19.6% iA-CPR (difference -0.6%; 95% CI -1.2% to 0.1%). Average time to AutoPulse start after defibrillator on was 172 seconds (±183). In 84% of the iA-CPR cases the device was not stopped during the first cycle of resuscitation. 74% of the defibrillated iA-CPR cases were shocked during compressions. Conclusion: This is the first study to document operational deployment of the AutoPulse. There was no difference in hands-off fraction between M-CPR and iA-CPR. Providers without prior experience using the AutoPulse shocked through compressions in the majority of cases.
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