Non-invasive respiratory support in paediatric critical care Respiratory
Conditions
Interventions
Current interventions as of 17/07/2020:
Study design/setting
Master protocol comprising two multi-centre, parallel groups, non-inferiority RCTs with shared infrastructure, and integrated health-econ
Sponsors
Great Ormond Street Hospital for Children NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
36 Weeks to 16 Years
Inclusion criteria
Inclusion criteria: 1. Admitted/accepted for admission to PICU/HDU 2. Age >36 weeks corrected gestational age and < 16 years 3. Assessed by the treating clinician to require non-invasive respiratory support, EITHER 3.1. For an acute illness (step-up RCT) OR 3.2. Within 72 hours of extubation following a period of invasive ventilation (step-down RCT)
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 02/03/2020: 1. Assessed by the treating clinician to require immediate intubation and invasive ventilation due to severe hypoxia, acidosis and/or respiratory distress, upper airway obstruction, difficulty managing airway secretions or recurrent apnoeas 2. Tracheostomy in place 3. Received HFNC/CPAP for > 2 hours in the prior 24 hours 4. On home non-invasive ventilation prior to PICU/HDU admission 5. Presence of untreated air-leak (pneumothorax and/or pneumomediastinum) 6. Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or recent craniofacial surgery 7. Agreed ‘not for intubation’ or other limitation of critical care treatment plan in place. 8. Previously recruited to the FIRST-ABC trial 9. Clinician decision to start other form of non-invasive respiratory support (i.e. not HFNC or CPAP) Previous participant exclusion criteria: 1. Assessed by the treating clinician to require immediate intubation and invasive ventilation due to severe hypoxia, acidosis and/or respiratory distress, upper airway obstruction, difficulty managing airway secretions or recurrent apnoeas 2. Tracheostomy in place 3. Received HFNC/CPAP for > 2 hours in the prior 24 hours 4. On home non-invasive ventilation prior to PICU/HDU admission 5. Presence of untreated air-leak (pneumothorax and/or pneumomediastinum) 6. Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or recent craniofacial surgery 7. Agreed ‘not for intubation’ or other limitation of critical care treatment plan in place. 8. Previously recruited to the FIRST-ABC trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to liberation from respiratory support, defined as the start of a 48-hour period during which the child was free of all forms of respiratory support | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 02/03/2020: 1. Mortality at PICU/HDU discharge, day 60 and day 180, assessed through review of patient medical notes at the relevant timepoints and/or data-linkage with nationally held death registrations 2. Rate of (re)intubation at 48 hours assessed through review of patient medical notes 3. Duration of PICU/HDU and hospital stay assessed through review of patient medical notes at PICU/HDU discharge and hospital discharge 4. Patient comfort during randomised treatment and during non-invasive respiratory support (i.e. HFNC and/or CPAP) measured using the COMFORT-B score 5. Proportion of patients in whom sedation is used during non-invasive respiratory support, assessed through review of patient medical notes 6. Parental stress in hospital at the time of consent, measured using the Parental Stressor Scale: PICU (PSS:PICU) 7. Health-related quality of life measured using age-appropriate Pediatric Quality of Life Inventory (Peds-QL) and the Child Health Utility 9D (CHU-9D) at 6 months 8. Total costs at 6 months 9. Quality-Adjusted Life Years (QALYs) at 6 months 10. Net monetary benefit gained at a willingness-to-pay of £20,000 per QALY at six months associated with HFNC vs. CPAP Previous secondary outcome measures: 1. Mortality at PICU/HDU discharge, day 60 and day 180, assessed through review of patient medical notes at the relevant timepoints and/or data-linkage with nationally held death registrations 2. Rate of (re)intubation at 48 hours assessed through review of patient medical notes 3. Duration of PICU/HDU and hospital stay assessed through review of patient medical notes at PICU/HDU discharge and hospital discharge 4. Patient comfort during randomised treatment measured using the COMFORT-B score 5. Proportion of patients in whom sedation is used during non-invasive respiratory support, assessed through review of patient medical notes 6. Parental stress in hospital at the time of consent, measured using the Parental Str | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed