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
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. Ho...
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07206-2 |
| _version_ | 1797863640170233856 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Razvan Azamfirei |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T22:39:56Z |
| format | Article |
| id | doaj.art-ed12eeab59254ef19bff1642bd0a5948 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T22:39:56Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-ed12eeab59254ef19bff1642bd0a59482023-03-22T12:18:19ZengBMCTrials1745-62152023-03-0124111110.1186/s13063-023-07206-2Impact of a multifaceted early mobility intervention for critically ill children — the PICU Up! trial: study protocol for a multicenter stepped-wedge cluster randomized controlled trialRazvan Azamfirei0Colleen Mennie1Victor D. Dinglas2Arooj Fatima3Elizabeth Colantuoni4Ayse P. Gurses5Michele C. Balas6Dale M. Needham7Sapna R. Kudchadkar8on behalf of the PICU Up! InvestigatorsDepartment of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of MedicineDepartment of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of MedicineDivision of Pulmonary and Critical Care Medicine, Johns Hopkins University School of MedicineDivision of Pulmonary and Critical Care Medicine, Johns Hopkins University School of MedicineOutcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins UniversityDepartment of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of MedicineCollege of Nursing, University of Nebraska Medical CenterDivision of Pulmonary and Critical Care Medicine, Johns Hopkins University School of MedicineDepartment of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of MedicineAbstract 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.https://doi.org/10.1186/s13063-023-07206-2Critical careIntensive care unitPediatricsRehabilitationCluster randomized controlled trial |
| spellingShingle | 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 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 Trials Critical care Intensive care unit Pediatrics Rehabilitation Cluster randomized controlled trial |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Critical care Intensive care unit Pediatrics Rehabilitation Cluster randomized controlled trial |
| url | https://doi.org/10.1186/s13063-023-07206-2 |
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