Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children: A pragmatic, stepped-wedge trial

项目总结 虽然美国儿科重症监护病房(PICU)的死亡率正在改善，但存活的儿童经常 形成持续性的身体、认知和心理障碍。超过一半的危重儿童 经历了可能可以预防的PICU获得性疾病，机械通风的儿童处于 最大的风险。在病情危重的成年人中，随机试验表明进行性活动很早就开始了 (在开始机械通气的3天内)，减少肌肉无力和持续时间 机械通风。然而，类似的随机研究还没有在PICU中进行。我们的前辈 研究表明，10%的危重儿童功能衰退的风险最高，他们的评估方法是 物理或职业治疗师在PICU入院后3天内。考虑到镇静、精神错乱的相互作用， 在PICU的睡眠和不动，单一成分干预，如镇静协议，没有 持续显示对减少机械通气持续时间的益处。因此，我们开发了第一个 儿科专科、跨专业干预(PICU UP！)将目标导向的镇静、神志不清 预防、促进睡眠和家庭参与到日常的PICU护理中，以促进早期和 渐进式机动性。我们已经证明了这一务实、多方面战略的安全性和可行性。 在单点和多中心试点研究中。因此，我们下一阶段的研究是评估 临床效果和交付的PICU起来了！对一系列PICU患者和健康人群的干预 系统。 我们提出了一项务实的、阶梯式、整群随机对照试验，将包括10名学者 和美国的社区医院(1,440名患者)，目的如下：1)评估 上PICU！在真实条件下实施的干预措施可缩短机械通风持续时间 (主要结果)，并改善危重儿童的神志不清和功能状态； 以及2)进行多个利益相关者、混合方法的过程评估，以确定关键的背景因素 与PICU UP的交付相关！ 如果被证明有效，PICU就起来了！干预措施有可能深刻改变中国的医疗保健 PICU，并通过改善越来越多的 危重病儿的幸存者。

PROJECT SUMMARY While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. Our prior studies revealed that <10% of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, we developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. We have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of our research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. We propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States (1,440 patients), with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.