Extracorporeal Membrane Oxygenation (ECMO)

Army Medical University of People's Liberation Army

Status: Completed

Conditions: Extracorporeal Membrane Oxygenation

Treatments: Device: conventional mechanical ventilation; Device: ECMO

Study type: Observational

Funder types: Other

Identifiers

NCT03607760

ECMO

Details and patient eligibility

About

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

Full 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)

Enrollment: 300 patients

Sex: All

Ages: 1 hour to 1 month old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ECMO group:

2. Oxygenation Index > 40 for >4 hours

3. Failure to wean from 100% oxygen despite prolonged (> 48h) maximal medical therapy or persistent episodes of decompensation

4. Severe hypoxic respiratory failure with acute decompensation (PaO2 <40) unresponsive to intervention

5. 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.

6. Non-ECMO group:

7. Oxygenation Index > 16 and reach the Montreux definition of severe respiratory distress syndrome

8. 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]

Exclusion criteria

1. Gestational age < 36 weeks, birth weight < 2 kg, day post-birth > 28 days.
2. lethal chromosomal disorder (includes trisomy 13, 18 but not 21) or any other lethal anomaly
3. irreversible brain damage
4. uncontrolled bleeding
5. Grade III or greater intraventricular hemorrhage
6. ventilator days ≥ 15 days.

Trial design

300 participants in 2 patient groups

ECMO

Description:

severe respiratory failure with ECMO

Treatment:

Device: ECMO

conventional mechanical ventilation

Description:

severe respiratory failure with conventional mechanical ventilation

Treatment:

Device: conventional mechanical ventilation