ARDS in Children and ECMO strategies impact on Neuro-Development
Research type
Research Study
Full title
ARDS in Children and ECMO initiation strategies impact on Neuro-Development (ASCEND)
IRAS ID
292537
Contact name
Mark Davidson
Contact email
Sponsor organisation
National Institute of Health
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 1 days
Research summary
Paediatric Acute Respiratory Distress Syndrome (PARDS) is a sudden life-threatening illness that requires mechanical ventilator support. If this fails the extra-corporeal membrane oxygenation (ECMO) may be used as a lifesaving supportive measure. There are no established guidelines, comparative effectiveness studies, or randomized clinical trials to inform the transition from mechanical ventilation to ECMO, with its recognised risk profile, but overuse or underuse of ECMO may have profound consequences. Initiating ECMO prior to ventilator failure may unnecessarily expose a child to the potential complications of ECMO. Alternatively, reserving ECMO initiation until conventional therapies fail may result in ventilator-induced lung injury or multisystem organ failure. The critical question: If and when should ECMO be initiated to preserve life while avoiding consequential complications?
Ideally, the impact of ECMO and its complications would be informed by knowledge of the long-term functional outcomes and quality of life of ECMO-supported children. There are no long-term outcomes studies of ECMO use in severe PARDS. This presents a critical knowledge gap as intensivists and families rank long-term functional status as the most important outcome beyond survival.
To answer the question of if or when ECMO should be initiated in these patients, it is necessary to compare the long-term outcomes in ECMO-supported children to otherwise similar children who did not receive ECMO at the same threshold. Ideally, this would be done via a randomized controlled clinical trial, but clinicians lack the equipoise necessary to randomize ECMO in this situation. The international Extra-corporeal Life Support Organisation (ELSO) Registry is a National Institute of Health (NIH) registered database where anonymised details of patients who are supported on ECMO are shared. ECMO is initiated at the discretion of the intensivist and the aim is to use this prospectively collated data in tandem with formalised structure neurological follow-up to answer this question.REC name
West of Scotland REC 1
REC reference
21/WS/0141
Date of REC Opinion
16 Dec 2021
REC opinion
Further Information Favourable Opinion