Clinical trial NCT06369584: Prone Position During ECMO in Pediatric Patients With Severe ARDS
Official title: Efficiency and Safety of Prone Position During Extracorporeal Membrane Oxygenation in Pediatric Patients With Severe Acute Respiratory Distress Syndrome: A Multi-center Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Acute Respiratory Distress Syndrome
Extracorporeal Membrane Oxygenation
Keywords: Extracorporeal Membrane oxygenation
pediatric acute respiratory distress syndrome
prone position ventilation
Lead sponsor: Seventh Medical Center of PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Gansu Provincial Maternal and Child Health Care Hospital
name: Xian Children's Hospital
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Henan Provincial People's Hospital
name: Guangdong Provincial People's Hospital
name: Shenzhen Bao'an Maternal and Child Health Hospital
name: Zhengzhou Children's Hospital
First posted: 2024-04-17
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

1. Age \< 1 month or \> 18 years old.
2. ECMO initiated for more than 48 hours.
3. 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).
4. Presence of irreversible brain injury or intracranial hypertension.
5. Children with irreversible lung disease awaiting lung transplantation.
6. Children with abdominal trauma or postoperative acute respiratory distress syndrome (ARDS).
7. Children in whom percutaneous cannulation cannot be performed due to unstable hemodynamics within the first 48 hours after ECMO support initiation.
8. Other contraindications for performing percutaneous cannulation.
9. Liver failure.
10. Burn area \>20% body surface area (BSA).

Primary outcomes:
measure: Mortality
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90
Secondary outcomes:
measure: Failure of supine position
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
measure: ECMO successful weaning rate
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
measure: Total duration of ECMO Support
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
measure: Number of ECMO-free days
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
measure: Duration of mechanical ventilation days after ECMO successful weaning.
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
measure: Duration of Pediatric Intensive Care Unit (PICU) stay.
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
measure: Duration of hospitalization
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
measure: Incidence of brain injury before discharge
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
measure: Number of days with organ failure
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
measure: Number of days alive without organ failure
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
measure: Number of ventilator assist pneumonia, bacteriemia, and cannula infection episodes
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
measure: Number of days with hemodynamic support with catecholamines
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
measure: Number of days without hemodynamic support with catecholamines
timeFrame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Seventh medical center of Chinese PLA General Hospital
state: Beijing
city: Lanzhou
country: China
facility: Gansu Provincial Maternal and Child Health Care Hospital
state: Gansu
city: Guangzhou
country: China
facility: The Second School of Clinical Medicine, Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Bao'an Maternity & Child Health Hospital
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Zhengzhou
country: China
facility: Henan Children's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Xi'an
country: China
facility: Xi'an Children's Hospital
state: Shaanxi
Study officials:
References: