PARDSProASIA: Pediatric Acute Respiratory Distress Syndrome Asia Study
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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 2years prior to and 2years subsequent to the implementation of the ventilator protocol.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Ventilator free days [up to 28 days]
Number of days alive and free of mechanical ventilation
- Intensive Care Unit free days [up to 28 days]
Number of days alive and discharge from the intensive care unit
- Extracorporeal membrane oxygenation [up to 28 days]
Number of participants who require ECMO
Other Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Satisfies the Pediatric Acute Lung Injury Consensus Conference (PALICC) criteria for PARDS
Exclusion Criteria:
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Premature neonates with a corrected age of less than 33 weeks and perinatal lung disease
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High flow nasal cannula
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Guangzhou Women and Children's Medical Center | Guangzhou | Guangzhou | China | |
2 | Shengjing hospital of China Medical University | Shenyang | Liaoning | China | |
3 | Children's Hospital of Fudan University | Shanghai | Shanghai | China | |
4 | Chongqing Hospital | Chongqing | Sichuan | China | |
5 | Hong Kong Children's Hospital | Kowloon Bay | Kowloon | Hong Kong | |
6 | Post Graduate Institute of Medical Education and Research | Chandigarh | India | ||
7 | Sanglah Hospital Denpasar | Denpasar | Bali | Indonesia | |
8 | Harapan Kita Children and Women hospital | Jakarta | Indonesia | ||
9 | Hyogo Prefectural Kobe Children's Hospital | Hyōgo | Kobe | Japan | |
10 | Universiti Kebangsaan Malaysia Medical Centre | Bandar Tun Razak | Kuala Lumpur | Malaysia | |
11 | Sarawak General Hospital | Kuching | Sarawak | Malaysia | |
12 | University Malaya Medical Centre | Kuala Lumpur | Malaysia | ||
13 | Aga Khan University Hospital | Karachi | Pakistan | ||
14 | KK Women's and Children's Hospital | Singapore | Singapore | 229899 | |
15 | National University Hospital, Singapore | Singapore | Singapore | ||
16 | Siriraj Hospital | Bangkok Noi | Bangkok | Thailand | |
17 | King Chulalongkorn Memorial Hospital | Bangkok | Thailand | ||
18 | Ramathibodi hospital | Bangkok | Thailand | ||
19 | National Hospital of Pediatrics | Dong Da | Hanoi | Vietnam |
Sponsors and Collaborators
- KK Women's and Children's Hospital
- 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
- Postgraduate 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
Investigators
- Principal Investigator: Judith Ju Ming Wong, KK Women's and Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017/3076(2)