跳至主要内容
临床试验/NCT06085326
NCT06085326招募中不适用

Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study

Children's Hospital of Philadelphia12 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年10月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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