Pediatric Acute Respiratory Distress Syndrome Asia Study

Summary

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.

Conditions

• Acute Respiratory Distress Syndrome
• Pediatric Intensive Care Unit
• Mechanical Ventilation

Interventions

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%).

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• Guangzhou Women and Children's Medical Center

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Children's Hospital of Fudan University

  collaborator OTHER

• Hong Kong Children's Hospital

  collaborator OTHER

• Sarawak General Hospital

  collaborator OTHER

• Universiti Kebangsaan Malaysia Medical Centre

  collaborator OTHER

• University of Malaya

  collaborator OTHER

• King Chulalongkorn Memorial Hospital

  collaborator OTHER

• Siriraj Hospital

  collaborator OTHER

• Ramathibodi Hospital

  collaborator OTHER

• National Children's Hospital, Vietnam

  collaborator OTHER

• Post Graduate Institute of Medical Education and Research, Chandigarh

  collaborator OTHER

• Rumah Sakit Anak dan Bunda Harapan Kita

  collaborator UNKNOWN

• Sanglah General Hospital

  collaborator OTHER

• General Hospital of North Sumatera University

  collaborator UNKNOWN

• Hyogo Prefectural Kobe Children's Hospital

  collaborator OTHER

• Aga Khan University

  collaborator OTHER

• National University Hospital, Singapore

  collaborator OTHER

• Singapore Clinical Research Institute

  collaborator OTHER

• KK Women's and Children's Hospital

  lead OTHER_GOV

Principal Investigators

• Judith Ju Ming Wong · KK Women's and Children's Hospital

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-01

Primary Completion

2023-03-31

Completion

2024-07-07

Countries

• China
• Hong Kong
• India
• Indonesia
• Japan
• Malaysia
• Pakistan
• Singapore
• Thailand
• Vietnam

Study Locations