PICU Up!:A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,500
- 试验地点
- 2
- 主要终点
- Duration of mechanical ventilation (days)
研究概览
简要总结
Recent decreases in Pediatric Intensive Care Unit (PICU) mortality rates have been offset by increased morbidity and length of stay for vulnerable young patients. Heavy sedation, bedrest, and delirium contribute to a PICU culture of immobility. While studies in adult ICU patients demonstrate the clinical benefits of early mobilization, fewer than 25% of critically ill children mobilize early in the children's PICU stay. The investigators have demonstrated the safety and feasibility of the 'PICU Up!' Mobility Program, which integrates sleep promotion, delirium prevention, sedation optimization as a bundle to increase mobilization. However, the generalizability and broader impact on patient- and family-centered outcomes is unknown. Therefore, there is an urgent need for trials that blend both clinical effectiveness and implementation research to create a PICU culture of mobility and improve the value of PICU care. The overall objective of the proposed research is to determine the impact of a transdisciplinary and multifaceted early mobility program on clinical outcomes and ICU-acquired morbidities in critically ill children. Additionally, the investigators will identify barriers and facilitators to high-performance bundle adoption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Participating Units:
- •Participating PICUs must be a separate physical space dedicated to the care of critically ill infants and children, with the ability to provide mechanical ventilation.
- •Not implemented a PICU mobility protocol and would commit to not implementing a mobility protocol until the randomized time of unit implementation.
- •Inclusion Criteria for Patients:
- •All patients admitted to the PICUs regardless of length of stay will receive the unit-based PICU Up! intervention, which includes criteria for no mobilization based on specific clinical factors (i.e. open chest, surgeon request).10 For inclusion in data analysis, patients will be eligible if
- •Admitted to the participating PICU ≥ 3 days.
排除标准
- •for Patients:
- •Patients with an active do-not-resuscitate (DNR) order will be excluded.
研究组 & 干预措施
PICU Up! pre- and post-implementation
Each unit will begin in the baseline, usual care phase and then be randomized to implement the PICU Up! program during a set time period, followed by the post-implementation phase.
干预措施: PICU Up! (Other)
结局指标
主要结局
Duration of mechanical ventilation (days)
时间窗: 28 days
Defined as the number of days of mechanical ventilation through an endotracheal tube during the first 28 days of PICU admission.
次要结局
- Number of patients discharged directly to home from the PICU(28 days)
- PICU length of stay (days)(28 days)
- Number of patients discharged from the hospital to a place other than home(28 days)
- Cumulative exposure to benzodiazepines (mg/kg) through PICU Day 28(28 days)
- Hospital length of stay (days)(28 days)
- Proportion of patients receiving out-of-bed mobility before PICU Day 28(28 days)
- Incidence of venous thromboembolism(28 days)
- Cumulative exposure to opioids (mg/kg) through PICU Day 28(28 days)
- Incidence of pressure injury(28 days)