Impact of a multifaceted early mobility intervention for critically ill children - the PICU Up! trial: study protocol for a multicenter stepped-wedge cluster randomized controlled trial.

Autor: Azamfirei R; Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.; 'George Emil Palade' University of Medicine, Pharmacy, Science, and Technology, Targu Mures, Romania., Mennie C; Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Dinglas VD; Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Outcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD, USA., Fatima A; Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Outcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD, USA., Colantuoni E; Outcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD, USA.; Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA., Gurses AP; Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Center for Health Care Human Factors, Armstrong Institute for Patient Safety and Quality, Johns Hopkins Medicine, Baltimore, MD, USA., Balas MC; College of Nursing, University of Nebraska Medical Center, Omaha, NE, USA., Needham DM; Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Outcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD, USA.; Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Kudchadkar SR; Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. sapna@jhmi.edu.; Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, USA. sapna@jhmi.edu.; Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA. sapna@jhmi.edu.
Jazyk: angličtina
Zdroj: Trials [Trials] 2023 Mar 15; Vol. 24 (1), pp. 191. Date of Electronic Publication: 2023 Mar 15.
DOI: 10.1186/s13063-023-07206-2
Abstrakt: Background: Over 50% of all critically ill children develop preventable intensive care unit-acquired morbidity. Early and progressive mobility is associated with improved outcomes in critically ill adults including shortened duration of mechanical ventilation and improved muscle strength. However, the clinical effectiveness of early and progressive mobility in the pediatric intensive care unit has never been rigorously studied. The objective of the study is to evaluate if the PICU Up! intervention, delivered in real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children. Additionally, the study aims to identify factors associated with reliable PICU Up! delivery.
Methods: The PICU Up! trial is a stepped-wedge, cluster-randomized trial of a pragmatic, interprofessional, and multifaceted early mobility intervention (PICU Up!) conducted in 10 pediatric intensive care units (PICUs). The trial's primary outcome is days alive free of mechanical ventilation (through day 21). Secondary outcomes include days alive and delirium- and coma-free (ADCF), days alive and coma-free (ACF), days alive, as well as functional status at the earlier of PICU discharge or day 21. Over a 2-year period, data will be collected on 1,440 PICU patients. The study includes an embedded process evaluation to identify factors associated with reliable PICU Up! delivery.
Discussion: This study will examine whether a multifaceted strategy to optimize early mobility affects the duration of mechanical ventilation, delirium incidence, and functional outcomes in critically ill children. This study will provide new and important evidence on ways to optimize short and long-term outcomes for pediatric patients.
Trial Registration: ClinicalTrials.gov NCT04989790. Registered on August 4, 2021.
(© 2023. The Author(s).)
Databáze: MEDLINE
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