RecruitingNot ApplicableNCT06369584

Prone Position During ECMO in Pediatric Patients With Severe ARDS

Efficiency and Safety of Prone Position During Extracorporeal Membrane Oxygenation in Pediatric Patients With Severe Acute Respiratory Distress Syndrome: A Multi-center Randomized Study


Sponsor

Seventh Medical Center of PLA General Hospital

Enrollment

7 participants

Start Date

May 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 MonthMax Age: 18 Years

Inclusion Criteria2

  • 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 Criteria10

  • 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).

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREprone position

The 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.


Locations(8)

Seventh medical center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Gansu Provincial Maternal and Child Health Care Hospital

Lanzhou, Gansu, China

The Second School of Clinical Medicine, Southern Medical University

Guangzhou, Guangdong, China

Shenzhen Bao'an Maternity & Child Health Hospital

Shenzhen, Guangdong, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Henan Children's Hospital

Zhengzhou, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Xi'an Children's Hospital

Xi'an, Shaanxi, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06369584


Related Trials