Establishment of a Early Risk Model of ECMO in Children With ARDS
Study Details
Study Description
Brief Summary
The key problem in the treatment of ARDS is refractory hypoxemia. Extracorporeal Membrane Oxygenation (ECMO) is an extracorporeal oxygenation of venous blood to eliminate carbon dioxide and return to the body. It has been an important part of the rescue treatment for ARDS. This study intends to explore the timing of ECMO. The main research hypothesis is that the appropriate timing of ECMO treatment can improve the weaning success rate and survival rate of children with severe ARDS; it is expected to provide a basis for determining the best timing of ECMO treatment
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Severe acute respiratory distress syndrome (ARDS), especially those caused by severe viral pneumonia, is still an important factor in the death of children, with a case fatality rate of 55%. The treatment includes lung protective ventilation and advanced ventilation support, but the effect is still not ideal for severe patients. ECMO can effectively support the respiratory system and provide good oxygen exchange. However, the survival rate of ECMO treatment in children with ARDS has a large bias.One of the key factors is the uneven timing of ECMO activation, which significantly affects the prognosis.This study intends to design a multi-center, prospective, non-randomized controlled trial , through retrospective research to find relevant factors affecting the prognosis of ECMO treatment, and to screen key indicators related to the timing of intervention; through a prospective cohort study to screen Good indicators and cut-off values suitable for starting ECMO , constructing and verifying comprehensive prediction models.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ARDS children children with severe ARDS |
Procedure: ECMO
VV-ECMO
|
Outcome Measures
Primary Outcome Measures
- Survival rate [28 days after hospital discharge]
The survival rate of children in 28 days after hospital discharge
Secondary Outcome Measures
- ECMO weaning rate [48 hours after ECMO weaning]
The success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours
Eligibility Criteria
Criteria
Inclusion Criteria:
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Acute onset; within 7 days of clinical insult
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Chest imaging (radiograph or computed tomography) findings of new infiltrates (unilateral or bilateral) consistent with acute parenchymal disease
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Edema not fully explained by fluid overload or cardiac failure
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May present as new acute lung disease in setting of chronic lung disease and/or heart disease
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OI≥16
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Viral etiology is clear
Exclusion Criteria:
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Perinatal lung disease
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Large intracranial bleed with mass effect or need for neurosurgical intervention
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Hypoxic cardiac arrest without adequate CPR
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Irreversible underlying cardiac or lung pathology (and not a transplant candidate)
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Pulmonary hypertension and chronic lung disease
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Chronic multiorgan dysfunction
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Incurable malignancy
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Allogenic bone marrow recipients with pulmonary infiltrates
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Hepatic or renal failure
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Pertussis infection in infants
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Fungal pneumonia
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Immunodeficiency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinese PLA General Hospital | Beijing | China | ||
| 2 | Children's Hospital of Chongqing Medical University | Chongqing | China | ||
| 3 | Guangdong Provincial People's Hospital | Guanzhou | China |
Sponsors and Collaborators
- Children's Hospital of Fudan University
- The Children's Hospital of Zhejiang University School of Medicine
- Children's Hospital of Chongqing Medical University
- Guangdong Provincial People's Hospital
- Chinese PLA General Hospital
Investigators
- Study Director: Ye Cheng, doctor, Children's Hospital of Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- fdpicu-07