Extracorporeal Membrane Oxygenation (ECMO)
- Conditions
- Extracorporeal Membrane Oxygenation
- Interventions
- Device: conventional mechanical ventilationDevice: ECMO
- Registration Number
- NCT03607760
- Lead Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Brief Summary
Since the 1970s, extracorporeal membrane oxygenation (ECMO) support has been used to support gas exchange for children with severe acute respiratory failure who fail mechanical ventilation. ECMO is more expensive than each of these other procedures.But its action is unclear
- Detailed Description
Since 1974, eight randomized controlled trials have been reported in ECMO for respiratory failure, and none have included non-neonatal pediatric patients. Cochrane systematic reviews of this evidence concluded that ECMO for neonatal respiratory failure had a survival advantage, but there was insufficient evidence to demonstrate a survival advantage for ECMO used to support respiratory failure in adults. Moreover, these trials were performed prior to 2009, and since then advances in ECMO technology have enhanced the delivery of ECMO support, and new research has changed conventional management of severe acute respiratory distress syndrome (ARDS)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
-
ECMO group:
-
Oxygenation Index > 40 for >4 hours
-
Failure to wean from 100% oxygen despite prolonged (> 48h) maximal medical therapy or persistent episodes of decompensation
-
Severe hypoxic respiratory failure with acute decompensation (PaO2 <40) unresponsive to intervention
-
Severe pulmonary hypertension with evidence of right ventricular dysfunction and/or left ventricular dysfunction. The pulmonary artery pressure > 60mmHg evaluated by the Echo, arterial duct keeps open and the blood flow was either by-level shunt or completely shunt from right side to left side.
-
Non-ECMO group:
-
Oxygenation Index > 16 and reach the Montreux definition of severe respiratory distress syndrome
-
Vasoactive-inotropic score (VIS) ≥ 40 [VIS=dopamine dose (μg/kg/min)×1 + dobutamine dose (μg/kg/min)×1 + milrinone dose (μg/kg/min)×10 + amrinone dose (μg/kg/min)×10 + epinephrine dose (μg/kg/min)×100 + isoprenaline dose (μg/kg/min)×100]
- Gestational age < 36 weeks, birth weight < 2 kg, day post-birth > 28 days.
- lethal chromosomal disorder (includes trisomy 13, 18 but not 21) or any other lethal anomaly
- irreversible brain damage
- uncontrolled bleeding
- Grade III or greater intraventricular hemorrhage
- ventilator days ≥ 15 days.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description conventional mechanical ventilation conventional mechanical ventilation severe respiratory failure with conventional mechanical ventilation ECMO ECMO severe respiratory failure with ECMO
- Primary Outcome Measures
Name Time Method 28 days' mortality 28 days the patients died
in-hospital mortality 36 weeks' gestational age or before discharge from hospital the patients died
- Secondary Outcome Measures
Name Time Method Intraventricular hemorrhage 36 weeks' gestational age or before discharge from hospital Intraventricular hemorrhage was diagnosed after extubation
Neonatal necrotizing enterocolitis 36 weeks' gestational age or before discharge from hospital Neonatal necrotizing enterocolitis was diagnosed after extubation
bronchopulmonary dysplasia 36 weeks' gestational age or before discharge from hospital bronchopulmonary dysplasia was diagnosed after extubation
Trial Locations
- Locations (1)
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
🇨🇳Chongqing, Chongqing, China