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.
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.
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超过50%的重症患儿发生可预防的重症监护病房获得性疾病。早期和渐进性活动与重症成人的结局改善相关，包括缩短机械通气持续时间和改善肌肉力量。然而，在儿科重症监护病房中早期和渐进式活动的临床有效性从未被严格研究过。该研究的目的是评估，如果PICU向上！与常规护理相比，在现实条件下实施的干预可缩短机械通气持续时间（主要结局），并改善危重儿童的谵妄和功能状态。此外，该研究旨在确定与可靠的PICU Up！交付. PICU起来了！试验是一项实用的、跨专业的、多方面的早期活动干预（PICU Up！）在10个儿科重症监护病房（PICU）进行。试验的主要结果是无机械通气的生存天数（至第21天）。次要结局包括无谵妄和无昏迷存活天数（ADCF）、无昏迷存活天数（ACF）、存活天数以及PICU出院或第21天（以较早者为准）的功能状态。在为期2年的时间内，将收集1，440名PICU患者的数据。该研究包括一个嵌入式过程评估，以确定与可靠的PICU Up！交付.本研究将探讨一个多方面的策略，以优化早期的流动性是否会影响机械通气的持续时间，谵妄的发生率和功能的结果，在危重病儿童。这项研究将为优化儿科患者的短期和长期结局提供新的重要证据。ClinicalTrials.gov NCT04989790。于2021年8月4日注册。在线版本包含补充材料，可通过10.1186/s13063-023-07206-2获得。
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. 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. 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. ClinicalTrials.gov NCT04989790. Registered on August 4, 2021. The online version contains supplementary material available at 10.1186/s13063-023-07206-2.
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