Actively Recruiting

Phase Not Applicable
Age: 1Month - 18Years
All Genders
NCT06369584

Prone Position During ECMO in Pediatric Patients With Severe ARDS

Led by Seventh Medical Center of PLA General Hospital · Updated on 2024-06-10

7

Participants Needed

8

Research Sites

59 weeks

Total Duration

On this page

Sponsors

S

Seventh Medical Center of PLA General Hospital

Lead Sponsor

G

Gansu Provincial Maternal and Child Health Care Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prone Position During ECMO in Pediatric Patients With Severe ARDS

Who Can Participate

Age: 1Month - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Severe Pediatric Acute Respiratory Distress Syndrome (PARDS) needing ECMO support, with ECMO started less than 48 hours ago
  • Informed consent given by the child's parent or legal guardian
Not Eligible

You will not qualify if you...

  • Age less than 1 month or older than 18 years
  • ECMO support started more than 48 hours ago
  • CPR lasting more than 10 minutes without return of circulation before ECMO, or extracorporeal CPR
  • Irreversible brain injury or high pressure inside the skull
  • Irreversible lung disease waiting for lung transplant
  • Abdominal trauma or ARDS after surgery
  • Unable to perform percutaneous cannulation due to unstable blood flow within first 48 hours of ECMO
  • Other reasons preventing percutaneous cannulation
  • Liver failure
  • Burns covering more than 20% of body surface area

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Seventh medical center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China, 100700

Actively Recruiting

2

Gansu Provincial Maternal and Child Health Care Hospital

Lanzhou, Gansu, China, 730050

Actively Recruiting

3

The Second School of Clinical Medicine, Southern Medical University

Guangzhou, Guangdong, China

Actively Recruiting

4

Shenzhen Bao'an Maternity & Child Health Hospital

Shenzhen, Guangdong, China, 518100

Actively Recruiting

5

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Actively Recruiting

6

Henan Children's Hospital

Zhengzhou, Henan, China, 450014

Actively Recruiting

7

Henan Provincial People's Hospital

Zhengzhou, Henan, China, 463599

Actively Recruiting

8

Xi'an Children's Hospital

Xi'an, Shaanxi, China, 710002

Actively Recruiting

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Research Team

X

Xiaoyang Hong, M.D.

CONTACT

Z

Zhe Zhao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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