Prone Position During ECMO in Pediatric Patients With Severe ARDS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorSeventh Medical Center of PLA General Hospital

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

7 Participants
are divided into 2 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