ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
University of Michigan
550 participants
Feb 4, 2021
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria22
- Previously enrolled in PROSpect
- Perinatal related lung disease
- Congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis
- Respiratory failure caused by cardiac failure or fluid overload
- Cyanotic congenital heart disease
- Cardiomyopathy
- Primary pulmonary hypertension (PAH)
- Unilateral lung disease
- Intubated for status asthmaticus
- Obstructive airway disease
- Bronchiolitis obliterans
- Post hematopoietic stem cell transplant
- Post lung transplant
- Home ventilator dependent
- Neuromuscular respiratory failure
- Head trauma: (managed with hyperventilation)
- Intracranial bleeding
- Unstable spine, femur or pelvic fractures
- Acute abdominal process/open abdomen
- Family/medical team have decided to not provide full support
- Enrolled in interventional clinical trial: not approved for co-enrollment; does not include cancer protocols.
- Known pregnancy
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Interventions
ECMO prescribed by treating physicians for respiratory support in the setting of PARDS.
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)
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NCT05388708