Prone Position During ECMO in Pediatric Patients With Severe ARDS

Last updated: June 7, 2024
Sponsor: Seventh Medical Center of PLA General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute Respiratory Distress Syndrome (Ards)

Lung Injury

Respiratory Failure

Treatment

prone position

Clinical Study ID

NCT06369584
PEPAD
  • Ages 1-18
  • All Genders

Study 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

Inclusion Criteria:

  • Severe PARDS and meets the criteria for ECMO support, has received ECMO support forless than 48 hours.

  • Informed consent obtained from the child's direct/legal guardian

Exclusion

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 10minutes before ECMO initiation without restoration of spontaneous circulation, orchildren 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 unstablehemodynamics 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).

Study Design

Total Participants: 7
Treatment Group(s): 1
Primary Treatment: prone position
Phase:
Study Start date:
May 09, 2024
Estimated Completion Date:
July 01, 2025

Connect with a study center

  • Seventh medical center of Chinese PLA General Hospital

    Beijing, Beijing 100700
    China

    Active - Recruiting

  • Gansu Provincial Maternal and Child Health Care Hospital

    Lanzhou, Gansu 730050
    China

    Active - Recruiting

  • The Second School of Clinical Medicine, Southern Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Shenzhen Bao'an Maternity & Child Health Hospital

    Shenzhen, Guangdong 518100
    China

    Active - Recruiting

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi
    China

    Active - Recruiting

  • Henan Children's Hospital

    Zhengzhou, Henan 450014
    China

    Active - Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 463599
    China

    Active - Recruiting

  • Xi'an Children's Hospital

    Xi'an, Shaanxi 710002
    China

    Active - Recruiting

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