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临床试验/NCT04068038
NCT04068038已完成不适用

Pediatric Acute Respiratory Distress Syndrome: a Prospective Asian Multicenter Study

KK Women's and Children's Hospital19 个研究点 分布在 10 个国家目标入组 738 人开始时间: 2019年8月1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
738
试验地点
19
主要终点
Prevalence of PARDS

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 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 showed varying practices with regards to pulmonary and non-pulmonary therapies, including ventilation. This study aims to determine the prevalence and outcomes of PARDS in the Pediatric Acute and Critical Care Medicine Asian Network (PACCMAN). This study will also determine the use of pulmonary (mechanical ventilation, steroids, neuromuscular blockade, surfactant, pulmonary vasodilators, prone positioning) and non-pulmonary (nutrition, sedation, fluid management, transfusion) PARDS therapies. To achieve this aim, a prospective observational study which involves systematic screening of all pediatric intensive care unit (PICU) admissions and collection of pertinent clinical data will be conducted. Recruitment will be consecutive and follow up will continue to intensive care discharge.

详细描述

The overall objective of this study is to prospectively determine the epidemiology of children with PARDS and describe its management in Asia. The first specific aim is to determine the prevalence of PARDS among PICU admissions. This will be achieved by establishing a systematic manner of screening patients and including them in this study. The second specific aim is to describe the use of pulmonary and non-pulmonary therapies in PARDS. This study will utilize an established dataset to extract pertinent and analyzable clinical data.The third specific aim is to determine the outcome of patients with PARDS. These outcomes will include functional data, PICU mortality, ventilator duration and length of stay data. This is a two-part study - the first part to establish the baseline prevalence and ventilator management strategies, the second part will include the implementation of an evidence based ventilation protocol as part of routine care. The same screening process, eligibility criteria and data collection will apply throughout the two parts. We aim to obtain data for approximately 2years prior to and 2years subsequent to the implementation of the ventilator protocol.

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

  • Satisfies the Pediatric Acute Lung Injury Consensus Conference (PALICC) criteria for PARDS

排除标准

  • Premature neonates with a corrected age of less than 33 weeks and perinatal lung disease
  • High flow nasal cannula

结局指标

主要结局

Prevalence of PARDS

时间窗: Through study completion

Number of participants diagnosed with PARDS over number of intensive care admissions

Mortality

时间窗: up to 60 days

Number of PARDS participants who died over number of participants diagnosed with PARDS

次要结局

  • Intensive Care Unit free days(up to 28 days)
  • Ventilator free days(up to 28 days)
  • Extracorporeal membrane oxygenation(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

Consultant Pediatric Critical Care

KK Women's and Children's Hospital

研究点 (19)

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