Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 12
- 主要终点
- Adverse Airway Outcomes
研究概览
简要总结
The purpose of the study is to implement a patient-provider dyad tailored, Electronic Health Record (EHR)-informed, digitized Smart Checklist as a Quality Improvement (QI) intervention to support bedside clinician teams to reduce Adverse Airway Outcomes (AAO) across 6 diverse pediatric intensive care units (ICUs).
详细描述
More than 20% of the critically ill children who require tracheal intubation suffer from adverse events. To reduce the adverse event risk, and optimize bedside team performance investigators will implement a digitized Smart Checklist that has three specific features: (1) prompts based on patient characteristics, (2) direct display of difficult airway status and airway information, and (3) high-risk warning based on predictive analytics.
This is a stepped-wedge cluster randomized trial of PICU patients who are intubated across 6 participating hospitals to determine if the Smart Checklist reduces the incidence of adverse tracheal intubation associated events.
The primary objective of this study is to determine the clinical impact of the personalized, dynamic, adaptive Smart Checklist implementation on the occurrence of Adverse Airway Outcomes (AAOs) in the pediatric ICU. The secondary objective is to characterize work systems and processes that affect clinical impact of the digitized Smart Checklist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 19 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients intubated in the PICU at participating sites
排除标准
- •Endotracheal tube exchanges, as this represents a distinct procedure
结局指标
主要结局
Adverse Airway Outcomes
时间窗: During the intubation procedure and up to 20 minutes after procedure
A composite outcome for adverse events or acute oxygen desaturation \<80%
次要结局
- Duration of invasive mechanical ventilation(During the ICU stay, up to 180 days)
- Duration of ICU stay(During the ICU stay, up to 180 days)
- ICU mortality(During the ICU stay, up to 180 days)
