Pediatric Acute Respiratory Distress Syndrome Asia Study
- Conditions
- Mechanical VentilationPediatric Intensive Care UnitAcute Respiratory Distress Syndrome
- Registration Number
- NCT04068038
- Lead Sponsor
- KK Women's and Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 738
- Satisfies the Pediatric Acute Lung Injury Consensus Conference (PALICC) criteria for PARDS
- Premature neonates with a corrected age of less than 33 weeks and perinatal lung disease
- High flow nasal cannula
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Extracorporeal membrane oxygenation up to 28 days Number of participants who require ECMO
Trial Locations
- Locations (19)
Guangzhou Women and Children's Medical Center
🇨🇳Guangzhou, Guangzhou, China
Shengjing hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Children's Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Chongqing Hospital
🇨🇳Chongqing, Sichuan, China
Hong Kong Children's Hospital
🇭🇰Kowloon Bay, Kowloon, Hong Kong
Post Graduate Institute of Medical Education and Research
🇮🇳Chandigarh, India
Sanglah Hospital Denpasar
🇮🇩Denpasar, Bali, Indonesia
Harapan Kita Children and Women hospital
🇮🇩Jakarta, Indonesia
Hyogo Prefectural Kobe Children's Hospital
🇯🇵Hyōgo, Kobe, Japan
Universiti Kebangsaan Malaysia Medical Centre
🇲🇾Bandar Tun Razak, Kuala Lumpur, Malaysia
Scroll for more (9 remaining)Guangzhou Women and Children's Medical Center🇨🇳Guangzhou, Guangzhou, China