Improving outcomes after pediatric cardiac arrest – the ICU-Resuscitation Project: study protocol for a randomized controlled trial

Autor: Reeder, Ron W, Girling, Alan, Wolfe, Heather, Holubkov, Richard, Berg, Robert A, Naim, Maryam Y, Meert, Kathleen L, Tilford, Bradley, Carcillo, Joseph A, Hamilton, Melinda, Bochkoris, Matthew, Hall, Mark, Maa, Tensing, Yates, Andrew R, Sapru, Anil, Kelly, Robert, Federman, Myke, Michael Dean, J, McQuillen, Patrick S, Franzon, Deborah, Pollack, Murray M, Siems, Ashley, Diddle, John, Wessel, David L, Mourani, Peter M, Zebuhr, Carleen, Bishop, Robert, Friess, Stuart, Burns, Candice, Viteri, Shirley, Hehir, David A, Whitney Coleman, R, Jenkins, Tammara L, Notterman, Daniel A, Tamburro, Robert F, Sutton, Robert M, Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN)
Rok vydání: 2018
Předmět:
Male
Resuscitation
Inservice Training
Time Factors
Quality management
Survival
medicine.medical_treatment
Medicine (miscellaneous)
Cardiorespiratory Medicine and Haematology
030204 cardiovascular system & hematology
Cardiovascular
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
Risk Factors
law
Medical Staff
Multicenter Studies as Topic
Pharmacology (medical)
Hospital Mortality
Child
Randomized Controlled Trials as Topic
Cardiopulmonary resuscitation (CPR)
Pediatric
Pediatric intensive care unit
lcsh:R5-920
Age Factors
Cardiac arrest
Quality Improvement
Intensive care unit
3. Good health
Stepped-wedge
Intensive Care Units
Heart Disease
Treatment Outcome
In-hospital
Child
Preschool
Female
lcsh:Medicine (General)
medicine.medical_specialty
Physical Injury - Accidents and Adverse Effects
Adolescent
Point-of-Care Systems
Clinical Trials and Supportive Activities
Clinical Sciences
education
Intensive Care Units
Pediatric
Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network
Hospital
03 medical and health sciences
Clinical Research
General & Internal Medicine
Intervention (counseling)
Medical Staff
Hospital
medicine
Humans
Cardiopulmonary resuscitation
Preschool
Patient Care Team
Protocol (science)
business.industry
Infant
Newborn
Infant
030208 emergency & critical care medicine
Newborn
Cardiopulmonary Resuscitation
United States
Hybrid
Heart Arrest
Cardiovascular System & Hematology
Emergency medicine
business
Zdroj: Trials
Trials, vol 19, iss 1
Trials, Vol 19, Iss 1, Pp 1-10 (2018)
ISSN: 1745-6215
DOI: 10.1186/s13063-018-2590-y
Popis: Background Quality of cardiopulmonary resuscitation (CPR) is associated with survival, but recommended guidelines are often not met, and less than half the children with an in-hospital arrest will survive to discharge. A single-center before-and-after study demonstrated that outcomes may be improved with a novel training program in which all pediatric intensive care unit staff are encouraged to participate in frequent CPR refresher training and regular, structured resuscitation debriefings focused on patient-centric physiology. Methods/design This ongoing trial will assess whether a program of structured debriefings and point-of-care bedside practice that emphasizes physiologic resuscitation targets improves the rate of survival to hospital discharge with favorable neurologic outcome in children receiving CPR in the intensive care unit. This study is designed as a hybrid stepped-wedge trial in which two of ten participating hospitals are randomly assigned to enroll in the intervention group and two are assigned to enroll in the control group for the duration of the trial. The remaining six hospitals enroll initially in the control group but will transition to enrolling in the intervention group at randomly assigned staggered times during the enrollment period. Discussion To our knowledge, this is the first implementation of a hybrid stepped-wedge design. It was chosen over a traditional stepped-wedge design because the resulting improvement in statistical power reduces the required enrollment by 9 months (14%). However, this design comes with additional challenges, including logistics of implementing an intervention prior to the start of enrollment. Nevertheless, if results from the single-center pilot are confirmed in this trial, it will have a profound effect on CPR training and quality improvement initiatives. Trial registration ClinicalTrials.gov, NCT02837497. Registered on July 19, 2016. Electronic supplementary material The online version of this article (10.1186/s13063-018-2590-y) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
Externí odkaz: