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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
prone position
Procedure/SurgeryThe process of prone positioning requires 5-6 people, with one person acting as the commander responsible for directing and monitoring. The process of monitoring includes ECMO flow and the vital signs. The second person is in charge of the patient's head, including endotracheal intubation, ventilator lines, and jugular ECMO cannula. The third person is responsible for femoral ECMO cannula and central venous line. The fourth to sixth individuals are responsible for rotating the patient's torso towards the side without an ECMO tube. Before initiating prone ventilation, pressure ulcer protection patches should be placed on the patient's forehead, ears, anterior chest, and iliac crest to protect areas under pressure. During ECMO support period, each patient needs to undergo at least four sessions of prone ventilation until their condition improves enough to discontinue ECMO support. Each session should last between 16 to 24 hours.
Treatment groups
7 Participants
are divided into 2 treatment groupsGroup A: prone position during ECMO in pediatric ARDSExperimental treatment 1 intervention
Group B: supine position during ECMO in pediatric ARDSNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Mortality
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.
Time frame
Day 7, Day 14, Day 30, Day 60, Day 90Secondary outcomes
1
Failure of supine position
The definition of failure of supine position: For patient ventilated with ECMO on supine position, when the fraction of oxygen of ECMO was set at 100% and fraction of ventilator oxygen was over 70%, saturation of the patient could not reach above 80%. This condition was defined as failure of supine position.
Time frame
Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.2
ECMO successful weaning rate
ECMO successful weaning rate means the patient still survive for more than 48 hours after weaning from ECMO.
Time frame
Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.3
Total duration of ECMO Support
Time frame
Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.4
Number of ECMO-free days
Number of ECMO-free days means the time for the patient to discharge from ECMO successful weaning.
Time frame
Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov