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Search / Trial NCT06369584

Prone Position During ECMO in Pediatric Patients With Severe ARDS

Launched by SEVENTH MEDICAL CENTER OF PLA GENERAL HOSPITAL · Apr 12, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Extracorporeal Membrane Oxygenation Pediatric Acute Respiratory Distress Syndrome Prone Position Ventilation

ClinConnect Summary

This clinical trial is looking at the use of a specific position called "prone positioning" for children with severe Acute Respiratory Distress Syndrome (ARDS) who are receiving a treatment called Extracorporeal Membrane Oxygenation (ECMO). ECMO is a life-support system that helps children breathe when their lungs are severely damaged. The trial is trying to find out if placing these children on their stomachs (prone position) while on ECMO can improve their chances of recovery. The research is important because current guidelines do not clearly state if this positioning helps, and the success rates of ECMO can vary.

To be eligible for this trial, children must be between 1 month and 18 years old, have severe ARDS, and have been receiving ECMO support for 48 hours or less. Their legal guardians must also provide consent for participation. If a child joins the study, they will receive ECMO while being monitored closely to see if the prone position helps improve their breathing and overall health. It's important to note that there are certain medical conditions that would prevent a child from participating, such as serious brain injuries or severe lung diseases. Overall, this trial aims to find better ways to help critically ill children breathe easier and recover more effectively.

Gender

ALL

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).

About Seventh Medical Center Of Pla General Hospital

The Seventh Medical Center of the PLA General Hospital is a leading clinical research institution in China, dedicated to advancing medical knowledge and improving patient care through innovative research and clinical trials. As a prominent affiliate of the People's Liberation Army, the center combines military and civilian healthcare expertise, ensuring high standards of clinical practices and rigorous scientific methodologies. With a focus on a wide range of medical specialties, the Seventh Medical Center is committed to fostering collaboration among healthcare professionals, researchers, and industry partners to develop effective therapies and enhance treatment outcomes for diverse patient populations.

Locations

Nanning, Guangxi, China

Zhengzhou, Henan, China

Beijing, Beijing, China

Lanzhou, Gansu, China

Guangzhou, Guangdong, China

Zhengzhou, Henan, China

Xi'an, Shaanxi, China

Shenzhen, Guangdong, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported