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临床试验/NCT03504176
NCT03504176已完成不适用

Pediatric Acute Respiratory Distress Syndrome Bundle vs. Standard Care; a Before-and-After Study

KK Women's and Children's Hospital1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2018年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
134
试验地点
1
主要终点
mortality

研究概览

简要总结

Mortality rates in children with pediatric acute respiratory distress syndrome (PARDS) are higher in Asia compared to other regions. In adults with acute respiratory distress syndrome, the only therapy that improves mortality rates is a lung protective ventilation strategy. The pediatric ventilation recommendations by the Pediatric Acute Lung Injury Consensus Conference (PALICC) are extrapolated from evidence in adults, including ventilation with low tidal volume, low peak/plateau pressures and high end expiratory pressure. A recent retrospective study of ventilation practices in Asia including Singapore showed that a majority of patients with PARDS were being ventilated with high tidal volume, high peak pressure and low end expiratory pressure, not in compliance with PALICC recommendations. We postulate that currently used ventilation strategies could have contributed to the high PARDS mortality rates in Asia. We aim to determine if implementing a ventilation bundle comprising PALICC recommendations lowers PARDS and pediatric intensive care unit (PICU) mortality rates.

详细描述

We implement a PARDS ventilation bundle compliant with PALICC recommendations. The bundle contains a daily checklist for ventilation targets and reference tables listing targeted tidal volumes and end expiratory pressure-fraction of inspired oxygen titration. We will recruit mechanically ventilated patients who meet PARDS criteria. After a one-month implementation period, we will collect patient data over the subsequent 18 months, and compare them with the corresponding data in the 24 months prior to the implementation. The primary outcome is PARDS mortality, defined as number of deaths out of PARDS cases. Secondary outcomes are feasibility of ventilation bundle implementation, ventilator (VFD) and intensive care unit (IFD) free days and PICU mortality (number of deaths out of PICU admissions).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • fulfill criteria for PARDS
  • mechanically ventilated

排除标准

  • perinatal lung disease

结局指标

主要结局

mortality

时间窗: up to 60 days

death during PICU stay

次要结局

  • PICU free days(up to 28 days)
  • ventilator free days(up to 28 days)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Judith Wong Ju-Ming

Dr

KK Women's and Children's Hospital

研究点 (1)

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