TY - JOUR
T1 - Effect of Physiologic Point-of-Care Cardiopulmonary Resuscitation Training on Survival with Favorable Neurologic Outcome in Cardiac Arrest in Pediatric ICUs
T2 - A Randomized Clinical Trial
AU - The ICU-RESUS and Eunice Kennedy Shriver National Institute of Child Health; Human Development Collaborative Pediatric Critical Care Research Network Investigator Groups
AU - Sutton, Robert M.
AU - Wolfe, Heather A.
AU - Reeder, Ron W.
AU - Ahmed, Tageldin
AU - Bishop, Robert
AU - Bochkoris, Matthew
AU - Burns, Candice
AU - Diddle, J. Wesley
AU - Federman, Myke
AU - Fernandez, Richard
AU - Franzon, Deborah
AU - Frazier, Aisha H.
AU - Friess, Stuart H.
AU - Graham, Kathryn
AU - Hehir, David
AU - Horvat, Christopher M.
AU - Huard, Leanna L.
AU - Landis, William P.
AU - Maa, Tensing
AU - Manga, Arushi
AU - Morgan, Ryan W.
AU - Nadkarni, Vinay M.
AU - Naim, Maryam Y.
AU - Palmer, Chella A.
AU - Schneiter, Carleen
AU - Sharron, Matthew P.
AU - Siems, Ashley
AU - Srivastava, Neeraj
AU - Tabbutt, Sarah
AU - Tilford, Bradley
AU - Viteri, Shirley
AU - Berg, Robert A.
AU - Bell, Michael J.
AU - Carcillo, Joseph A.
AU - Carpenter, Todd C.
AU - Dean, J. Michael
AU - Fink, Ericka L.
AU - Hall, Mark
AU - McQuillen, Patrick S.
AU - Meert, Kathleen L.
AU - Mourani, Peter M.
AU - Notterman, Daniel
AU - Pollack, Murray M.
AU - Sapru, Anil
AU - Wessel, David
AU - Yates, Andrew R.
AU - Zuppa, Athena F.
N1 - Funding Information:
Funding/Support: This study was funded by grants R01HL131544 from the National Heart, Lung, and Blood Institute and U01HD049934, UG1HD049981, UG1HD049983, UG1HD050096, UG1HD063108, UG1HD083166, UG1HD083170, and UG1HD083171 from the National Institute of Child Health and Human Development.
Funding Information:
This document was prepared by the CPCCRN Data Coordinating Center located at the University of Utah School of Medicine, Salt Lake City, Utah. The CPCCRN Data Coordinating Center at the University of Utah is supported by Cooperative Agreement U01-HD049934 from the National Heart,Lung, and Blood Institute (NHLBI). The document was written and typeset using LATEX 2ε.
Funding Information:
The CPCCRN Clinical Centers are the Children’s Hospital Colorado, Children’s Hospital of Michigan, Children’s Hospital of Philadelphia, Children’s Hospital of Pittsburgh, Children’s National Medical Center, Nationwide Children’s Hospital, and the University of California San Francisco, and are supported by Cooperative Agreements UG1-HD083171, UG1-HD050096, UG1-HD063108, UG1-HD049983, UG1-HD049981, UG1-HD083170, and UG1-HD083166, respectively, from the Eunice Kennedy Shriver National Heart,Lung, and Blood Institute (NHLBI).
Funding Information:
reported receiving grants from the National Institutes of Health (NIH) and serving as a volunteer for the American Heart Association. Dr Morgan reported receiving grant funding from the NIH (K23HL148541) and volunteering for the American Heart Association. Dr Carcillo reported receiving grant funding from the NIH. Dr Carpenter reported receiving grant funding from the NIH. Dr Dean reported receiving grant funding from the NIH. Dr Fink reported receiving grant funding from the NIH and Neurocritical Care Society. Dr Hall reported receiving grant funding from the NIH, serving on the DSMBs of La Jolla Pharmaceuticals and AbbVie, and earing income for licensing from Kiadis. Dr Meert reported receiving grant funding from the NIH. Dr Mourani reported receiving grant funding from the NIH. Dr Pollack reported receiving grant funding from the NIH and from Mallinckrodt Pharmaceuticals, LLC. Dr Wessel reported receiving grant funding from the NIH. Dr Zuppa reported receiving grant funding from the NIH.
Funding Information:
The NIH funded parent grant (R01HL131544) has received an ancillary grant (PAR-18-643) from the NIH. "Validation of Physiologic CPR Quality Using NOn-inVasive Waveform Analytics (CPR-NOVA)" was funded pending IRB approval. The grant adds ancillary aims and will collect some additional data from enrolled subjects as described below.
Publisher Copyright:
© 2022 American Medical Association. All rights reserved.
PY - 2022/3/8
Y1 - 2022/3/8
N2 - Importance: Approximately 40% of children who experience an in-hospital cardiac arrest survive to hospital discharge. Achieving threshold intra-arrest diastolic blood pressure (BP) targets during cardiopulmonary resuscitation (CPR) and systolic BP targets after the return of circulation may be associated with improved outcomes. Objective: To evaluate the effectiveness of a bundled intervention comprising physiologically focused CPR training at the point of care and structured clinical event debriefings. Design, Setting, and Participants: A parallel, hybrid stepped-wedge, cluster randomized trial (Improving Outcomes from Pediatric Cardiac Arrest-the ICU-Resuscitation Project [ICU-RESUS]) involving 18 pediatric intensive care units (ICUs) from 10 clinical sites in the US. In this hybrid trial, 2 clinical sites were randomized to remain in the intervention group and 2 in the control group for the duration of the study, and 6 were randomized to transition from the control condition to the intervention in a stepped-wedge fashion. The index (first) CPR events of 1129 pediatric ICU patients were included between October 1, 2016, and March 31, 2021, and were followed up to hospital discharge (final follow-up was April 30, 2021). Intervention: During the intervention period (n = 526 patients), a 2-part ICU resuscitation quality improvement bundle was implemented, consisting of CPR training at the point of care on a manikin (48 trainings/unit per month) and structured physiologically focused debriefings of cardiac arrest events (1 debriefing/unit per month). The control period (n = 548 patients) consisted of usual pediatric ICU management of cardiac arrest. Main Outcomes and Measures: The primary outcome was survival to hospital discharge with a favorable neurologic outcome defined as a Pediatric Cerebral Performance Category score of 1 to 3 or no change from baseline (score range, 1 [normal] to 6 [brain death or death]). The secondary outcome was survival to hospital discharge. Results: Among 1389 cardiac arrests experienced by 1276 patients, 1129 index CPR events (median patient age, 0.6 [IQR, 0.2-3.8] years; 499 girls [44%]) were included and 1074 were analyzed in the primary analysis. There was no significant difference in the primary outcome of survival to hospital discharge with favorable neurologic outcomes in the intervention group (53.8%) vs control (52.4%); risk difference (RD), 3.2% (95% CI,-4.6% to 11.4%); adjusted OR, 1.08 (95% CI, 0.76 to 1.53). There was also no significant difference in survival to hospital discharge in the intervention group (58.0%) vs control group (56.8%); RD, 1.6% (95% CI,-6.2% to 9.7%); adjusted OR, 1.03 (95% CI, 0.73 to 1.47). Conclusions and Relevance: In this randomized clinical trial conducted in 18 pediatric intensive care units, a bundled intervention of cardiopulmonary resuscitation training at the point of care and physiologically focused structured debriefing, compared with usual care, did not significantly improve patient survival to hospital discharge with favorable neurologic outcome among pediatric patients who experienced cardiac arrest in the ICU. Trial Registration: ClinicalTrials.gov Identifier: NCT02837497.
AB - Importance: Approximately 40% of children who experience an in-hospital cardiac arrest survive to hospital discharge. Achieving threshold intra-arrest diastolic blood pressure (BP) targets during cardiopulmonary resuscitation (CPR) and systolic BP targets after the return of circulation may be associated with improved outcomes. Objective: To evaluate the effectiveness of a bundled intervention comprising physiologically focused CPR training at the point of care and structured clinical event debriefings. Design, Setting, and Participants: A parallel, hybrid stepped-wedge, cluster randomized trial (Improving Outcomes from Pediatric Cardiac Arrest-the ICU-Resuscitation Project [ICU-RESUS]) involving 18 pediatric intensive care units (ICUs) from 10 clinical sites in the US. In this hybrid trial, 2 clinical sites were randomized to remain in the intervention group and 2 in the control group for the duration of the study, and 6 were randomized to transition from the control condition to the intervention in a stepped-wedge fashion. The index (first) CPR events of 1129 pediatric ICU patients were included between October 1, 2016, and March 31, 2021, and were followed up to hospital discharge (final follow-up was April 30, 2021). Intervention: During the intervention period (n = 526 patients), a 2-part ICU resuscitation quality improvement bundle was implemented, consisting of CPR training at the point of care on a manikin (48 trainings/unit per month) and structured physiologically focused debriefings of cardiac arrest events (1 debriefing/unit per month). The control period (n = 548 patients) consisted of usual pediatric ICU management of cardiac arrest. Main Outcomes and Measures: The primary outcome was survival to hospital discharge with a favorable neurologic outcome defined as a Pediatric Cerebral Performance Category score of 1 to 3 or no change from baseline (score range, 1 [normal] to 6 [brain death or death]). The secondary outcome was survival to hospital discharge. Results: Among 1389 cardiac arrests experienced by 1276 patients, 1129 index CPR events (median patient age, 0.6 [IQR, 0.2-3.8] years; 499 girls [44%]) were included and 1074 were analyzed in the primary analysis. There was no significant difference in the primary outcome of survival to hospital discharge with favorable neurologic outcomes in the intervention group (53.8%) vs control (52.4%); risk difference (RD), 3.2% (95% CI,-4.6% to 11.4%); adjusted OR, 1.08 (95% CI, 0.76 to 1.53). There was also no significant difference in survival to hospital discharge in the intervention group (58.0%) vs control group (56.8%); RD, 1.6% (95% CI,-6.2% to 9.7%); adjusted OR, 1.03 (95% CI, 0.73 to 1.47). Conclusions and Relevance: In this randomized clinical trial conducted in 18 pediatric intensive care units, a bundled intervention of cardiopulmonary resuscitation training at the point of care and physiologically focused structured debriefing, compared with usual care, did not significantly improve patient survival to hospital discharge with favorable neurologic outcome among pediatric patients who experienced cardiac arrest in the ICU. Trial Registration: ClinicalTrials.gov Identifier: NCT02837497.
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U2 - 10.1001/jama.2022.1738
DO - 10.1001/jama.2022.1738
M3 - Article
C2 - 35258533
AN - SCOPUS:85125981466
SN - 0098-7484
VL - 327
SP - 934
EP - 945
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 10
ER -