ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
University of Michigan
Summary
ASCEND researchers are partnering with families of children who receive extracorporeal membrane oxygenation (ECMO) after a sudden failure of breathing named pediatric acute respiratory distress syndrome (PARDS). ECMO is a life support technology that uses an artificial lung outside of the body to do the lung's work. ASCEND has two objectives. The first objective is to learn more about children's abilities and quality of life among ECMO-supported children in the year after they leave the pediatric intensive care unit. The second objective is to compare short and long-term patient outcomes in two groups of children: one group managed with a mechanical ventilation protocol that reserves the use of extracorporeal membrane oxygenation (ECMO) until protocol failure to another group supported on ECMO per usual care.
Description
Decades after extracorporeal membrane oxygenation (ECMO) was first used to support children with severe pediatric acute respiratory distress syndrome (PARDS), pediatric intensivists lack both prospective studies of long-term outcomes in ECMO for PARDS and well-powered studies comparing the impact of ECMO initiation strategies on mortality and morbidity. While clinicians lack the equipoise necessary to randomize ECMO in dying children, there is uncertainty on if and when it is best to initiate ECMO to preserve survival, functioning, and quality of life. To determine if and when ECMO should be i…
Eligibility
- Age range
- 0–20 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Time between intubation and ECMO cannulation is less than 240 hours (10 days) * ECMO support type is respiratory (VV or VA cannulation) * Chest radiograph with bilateral lung disease * Moderate or severe pediatric ARDS as measured by oxygenation index or oxygen saturation index after intubation and prior to ECMO cannulation: One OI ≥ 16 or Two OIs ≥ 12 and ≤ 16 at least four hours apart or Two OSIs ≥ 10 at least four hours apart or One OI ≥ 12 and ≤ 16 and One OSI ≥ 10 at least four hours apart Exclusion Criteria: * Previously enrolled in PROSpect * Perinatal related…
Interventions
- DeviceECMO support
ECMO prescribed by treating physicians for respiratory support in the setting of PARDS.
- OtherPROSpect protocolized therapies
PROSpect is testing the impact of supine/prone positioning and conventional mechanical ventilation (CMV)/high-frequency oscillatory ventilation (HFOV) on clinical outcomes in 1,000 children with severe PARDS. PROSpect manages severe PARDS subjects using a protocol that reserves ECMO for protocol failure. The CMV group targets an exhaled tidal volume of 5-7mL/kg of ideal body weight and a peak inspiratory pressure \<28 cm of H2O. The positive end expiratory pressure (PEEP) and FiO2 are titrated by a PEEP-FiO2 titration grid. The HFOV group titrates the mean airway pressure to target a FiO2 \< 0.5 and a goal hemoglobin oxygen saturation of 88-92%. The frequency is titrated between 8-12 Hz and amplitude from 60-90 to achieve a goal pH of 7.15-7.30. Ventilation protocols are implemented until 28 days or extubation. Children randomized to the prone positioning will remain prone for at least 16 consecutive hours per day. Children randomized to supine positioning group remain supine.
Locations (99)
- Children's of AlabamaBirmingham, Alabama
- Phoenix Children's HospitalPhoenix, Arizona
- Arkansas Children's HospitalLittle Rock, Arkansas
- Loma Linda University Children's HospitalLoma Linda, California
- UCLA Mattel Children's HospitalLos Angeles, California
- Valley Children's HospitalMadera, California