Pediatric Acute Respiratory Distress Syndrome Asia Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pediatric Acute Respiratory Distress Syndrome: a Prospective Asian Multicenter Study

Conditions
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Acute Respiratory Distress Syndrome, Pediatric Intensive Care Unit, Mechanical Ventilation

Intervention / Treatment
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* Other: Ventilation protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Satisfies the Pediatric Acute Lung Injury Consensus Conference (PALICC) criteria for PARDS Exclusion Criteria: Premature neonates with a corrected age of less than 33 weeks and perinatal lung disease High flow nasal cannula

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Ventilation protocol|An evidence based ventilation protocol will be implemented at participating sites. This will include limits on peak inspiratory pressure (28cmH2O), driving pressure (16cmH2O), tidal volume (mild 8ml/kg, mod/severe 6ml/kg), positive end expiratory pressure to fraction of inspired oxygen table, permissive hypercarbia (mild allow pH 7.30, mod/severe allow pH 7.20) and permissive hypoxia (mild SpO2 92-97%, mod/severe SpO2 88-92%).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of PARDS | Number of participants diagnosed with PARDS over number of intensive care admissions | Through study completion | 
| Mortality | Number of PARDS participants who died over number of participants diagnosed with PARDS | up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator free days | Number of days alive and free of mechanical ventilation | up to 28 days | 
| Intensive Care Unit free days | Number of days alive and discharge from the intensive care unit | up to 28 days | 
| Extracorporeal membrane oxygenation | Number of participants who require ECMO | up to 28 days |