Acute Respiratory Distress Syndrome, Mechanical Ventilation, Pediatric Intensive Care Unit
Conditions
Brief 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.
Detailed description
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.
Interventions
OTHERVentilation 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
Children's Hospital of Chongqing Medical University
Guangzhou Women and Children's Medical Center
Shengjing Hospital
Children's Hospital of Fudan University
Hong Kong Children's Hospital
Sarawak General Hospital
Universiti Kebangsaan Malaysia Medical Centre
University of Malaya
King Chulalongkorn Memorial Hospital
Siriraj Hospital
Ramathibodi Hospital
National Children's Hospital, Vietnam
Post Graduate Institute of Medical Education and Research, Chandigarh
Rumah Sakit Anak dan Bunda Harapan Kita
Sanglah General Hospital
General Hospital of North Sumatera University
Hyogo Prefectural Kobe Children's Hospital
Aga Khan University
National University Hospital, Singapore
Singapore Clinical Research Institute
KK Women's and Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of PARDS | Through study completion | Number of participants diagnosed with PARDS over number of intensive care admissions |
| Mortality | up to 60 days | Number of PARDS participants who died over number of participants diagnosed with PARDS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extracorporeal membrane oxygenation | up to 28 days | Number of participants who require ECMO |
| Intensive Care Unit free days | up to 28 days | Number of days alive and discharge from the intensive care unit |
| Ventilator free days | up to 28 days | Number of days alive and free of mechanical ventilation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Composite mortality and ECMO | up to 60 days | Number of PARDS participants who died or required ECMO over total number of participants diagnosed with PARDS |
| Sensitivity analysis | up to 60 days | Mortality and secondary outcomes excluding limitation of care orders |
Countries
China, Hong Kong, India, Indonesia, Japan, Malaysia, Pakistan, Singapore, Thailand, Vietnam
Outcome results
None listed