About this trial
In 2023, the second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) updated the diagnostic and management guidelines for Pediatric Acute Respiratory Distress Syndrome (PARDS). The guidelines do not provide sufficient evidence-based recommendations on whether prone positioning ventilation is necessary for severe PARDS patients. However, the effectiveness of Extracorporeal Membrane Oxygenation (ECMO) in treating severe PARDS has been fluctuating around 70% according to recent data from Extracorporeal Life Support Organization (ELSO).
In 2018, the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS. However, this retrospective study mainly focused on data from North America, with significant variations in annual ECMO support cases among different centers, which may introduce bias. With advancements in ECMO technology and materials, ECMO has become safer and easier to operate. In recent years, pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly.
ECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment. When optimizing ventilator parameters (titrating positive end expiratory pressure (PEEP) levels, neuromuscular blockers, prone positioning), strict fluid management alone cannot maintain satisfactory oxygenation (P/F\<80mmHg or Oxygen Index (OI) \>40 for over 4 hours or OI \>20 for over 24 hours), initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury.
Eligibility criteria
Qualifiers
Severe PARDS and meets the criteria for ECMO support, has received ECMO support for less than 48 hours.
Informed consent obtained from the child's direct/legal guardian
Disqualifiers
Age < 1 month or > 18 years old.
ECMO initiated for more than 48 hours.
Children who have undergone cardiopulmonary resuscitation (CPR) for more than 10 minutes before ECMO initiation without restoration of spontaneous circulation, or children undergoing extracorporeal cardiopulmonary resuscitation (ECPR).
Presence of irreversible brain injury or intracranial hypertension.
Trial design
Treatments tested in this trial
- prone position
Treatment groups
Sponsors and collaborators
Seventh Medical Center of PLA General Hospital
Lead sponsor
Gansu Provincial Maternal and Child Health Care Hospital
Collaborator
Xian Children's Hospital
Collaborator
People's Hospital of Guangxi Zhuang Autonomous Region
Collaborator
Henan Provincial People's Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Shenzhen Bao'an Maternal and Child Health Hospital
Collaborator
Zhengzhou Children's Hospital
Collaborator