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Design of the circulation improving resuscitation care (CIRC) trial: a new state of the art design for out-of-hospital cardiac arrest research

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Design of the circulation improving resuscitation care (CIRC) trial: a new state of the art design for out-of-hospital cardiac arrest research. / Lerner, E. Brooke; Persse, David ; Souders, Chris et al.
In: Resuscitation, Vol. 82, No. 3, 03.2011, p. 294-299.

Research output: Contribution to Journal/MagazineJournal articlepeer-review

Harvard

Lerner, EB, Persse, D, Souders, C, Sterz, F, Malzer, R, Lozano, M, Westfall, M, Brouwer, MA, Grunsven, PMV, Whitehead, A, Olsen, J-A, Herken, UR & Wik, L 2011, 'Design of the circulation improving resuscitation care (CIRC) trial: a new state of the art design for out-of-hospital cardiac arrest research', Resuscitation, vol. 82, no. 3, pp. 294-299. https://doi.org/10.1016/j.resuscitation.2010.11.013

APA

Lerner, E. B., Persse, D., Souders, C., Sterz, F., Malzer, R., Lozano, M., Westfall, M., Brouwer, M. A., Grunsven, P. M. V., Whitehead, A., Olsen, J-A., Herken, U. R., & Wik, L. (2011). Design of the circulation improving resuscitation care (CIRC) trial: a new state of the art design for out-of-hospital cardiac arrest research. Resuscitation, 82(3), 294-299. https://doi.org/10.1016/j.resuscitation.2010.11.013

Vancouver

Lerner EB, Persse D, Souders C, Sterz F, Malzer R, Lozano M et al. Design of the circulation improving resuscitation care (CIRC) trial: a new state of the art design for out-of-hospital cardiac arrest research. Resuscitation. 2011 Mar;82(3):294-299. doi: 10.1016/j.resuscitation.2010.11.013

Author

Lerner, E. Brooke ; Persse, David ; Souders, Chris et al. / Design of the circulation improving resuscitation care (CIRC) trial: a new state of the art design for out-of-hospital cardiac arrest research. In: Resuscitation. 2011 ; Vol. 82, No. 3. pp. 294-299.

Bibtex

@article{9cac0d7a15274cac82c62e2afca5f5d8,
title = "Design of the circulation improving resuscitation care (CIRC) trial: a new state of the art design for out-of-hospital cardiac arrest research",
abstract = "PurposeMechanical chest compression devices, such as the AutoPulse{\textregistered}, 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{\textregistered}-CPR) in a randomized controlled trial that addresses methodological issues that may have influenced the results of previous studies.MethodsThis paper describes the methodology of the CIRC trial.ResultsUnlike 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.ConclusionThis 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.",
keywords = "Cardiac arrest, Research methods, Study design",
author = "Lerner, {E. Brooke} and David Persse and Chris Souders and Fritz Sterz and Reinhard Malzer and Michael Lozano and Mark Westfall and Brouwer, {Marc A.} and Grunsven, {Pierre M. van} and Anne Whitehead and Jan-Aage Olsen and Herken, {Ulrich R.} and Lars Wik",
year = "2011",
month = mar,
doi = "10.1016/j.resuscitation.2010.11.013",
language = "English",
volume = "82",
pages = "294--299",
journal = "Resuscitation",
issn = "1873-1570",
publisher = "Elsevier Ireland Ltd",
number = "3",

}

RIS

TY - JOUR

T1 - Design of the circulation improving resuscitation care (CIRC) trial: a new state of the art design for out-of-hospital cardiac arrest research

AU - Lerner, E. Brooke

AU - Persse, David

AU - Souders, Chris

AU - Sterz, Fritz

AU - Malzer, Reinhard

AU - Lozano, Michael

AU - Westfall, Mark

AU - Brouwer, Marc A.

AU - Grunsven, Pierre M. van

AU - Whitehead, Anne

AU - Olsen, Jan-Aage

AU - Herken, Ulrich R.

AU - Wik, Lars

PY - 2011/3

Y1 - 2011/3

N2 - PurposeMechanical 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.MethodsThis paper describes the methodology of the CIRC trial.ResultsUnlike 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.ConclusionThis 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.

AB - PurposeMechanical 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.MethodsThis paper describes the methodology of the CIRC trial.ResultsUnlike 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.ConclusionThis 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.

KW - Cardiac arrest

KW - Research methods

KW - Study design

U2 - 10.1016/j.resuscitation.2010.11.013

DO - 10.1016/j.resuscitation.2010.11.013

M3 - Journal article

VL - 82

SP - 294

EP - 299

JO - Resuscitation

JF - Resuscitation

SN - 1873-1570

IS - 3

ER -