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Trials
Published in: Trials 1/2023

Open Access 01-12-2023 | Care | Study protocol

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

Authors: Razvan Azamfirei, Colleen Mennie, Victor D. Dinglas, Arooj Fatima, Elizabeth Colantuoni, Ayse P. Gurses, Michele C. Balas, Dale M. Needham, Sapna R. Kudchadkar, on behalf of the PICU Up! Investigators

Published in: Trials | Issue 1/2023

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Abstract

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.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Razvan Azamfirei
Colleen Mennie
Victor D. Dinglas
Arooj Fatima
Elizabeth Colantuoni
Ayse P. Gurses
Michele C. Balas
Dale M. Needham
Sapna R. Kudchadkar
on behalf of the PICU Up! Investigators
Publication date
01-12-2023
Publisher
BioMed Central
Keywords
Care
Coma
Published in
Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07206-2

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