Efficiency and Safety of Prone Position During Extracorporeal Membrane Oxygenation in Pediatric Patients With Severe Acute Respiratory Distress Syndrome: A Multi-center Randomized Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Seventh Medical Center of PLA General Hospital
- Enrollment
- 7
- Locations
- 8
- Primary Endpoint
- Mortality
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
- •Children with irreversible lung disease awaiting lung transplantation.
- •Children with abdominal trauma or postoperative acute respiratory distress syndrome (ARDS).
- •Children in whom percutaneous cannulation cannot be performed due to unstable hemodynamics within the first 48 hours after ECMO support initiation.
- •Other contraindications for performing percutaneous cannulation.
- •Liver failure.
- •Burn area \>20% body surface area (BSA).
Outcomes
Primary Outcomes
Mortality
Time Frame: Day 7, Day 14, Day 30, Day 60, Day 90
Survive means that the patient would survive without ECMO support and survival requires follow-up until at least 30 days after ECMO withdrawal. Whether the child requires long-term mechanical ventilation or home oxygen therapy after ECMO withdrawal will be considered. A protocolized management regarding weaning of ECMO will be applied to both groups in all involved centers. The planned analysis will model the risk of death.
Secondary Outcomes
- Failure of supine position(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)
- ECMO successful weaning rate(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)
- Duration of mechanical ventilation days after ECMO successful weaning.(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)
- Duration of Pediatric Intensive Care Unit (PICU) stay.(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)
- Incidence of brain injury before discharge(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)
- Number of ECMO-free days(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)
- Number of days with organ failure(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)
- Number of days with hemodynamic support with catecholamines(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)
- Total duration of ECMO Support(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)
- Duration of hospitalization(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)
- Number of days without hemodynamic support with catecholamines(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)
- Number of days alive without organ failure(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)
- Number of ventilator assist pneumonia, bacteriemia, and cannula infection episodes(Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.)