Critical care Not Applicable
Conditions
Interventions
The researchers will recruit 2040 patients from 15 paediatric critical care units and their associated specialist retrieval services (teams of doctors and nurses that attend local hospitals to assist
Sponsors
Intensive Care National Audit and Research Centre (ICNARC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >38 weeks corrected gestational age and <16 years 2. Unplanned PICU referral 3. Commenced on invasive mechanical ventilation with supplemental oxygen 4. Within 6 hours of face-to-face contact with PICU staff or retrieval team
Exclusion criteria
Exclusion criteria: 1. Death perceived as imminent 2. Brain pathology/injury as primary reason for admission 3. Known pulmonary hypertension 4. Known or suspected uncorrected congenital cardiac disease 5. Known sickle cell disease 6. End-of-life care plan in place with limitation of resuscitation 7. Receiving long-term mechanical ventilation prior to this admission 8. Recruited to Oxy-PICU in a previous admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. A composite of mortality and days of organ support at 30 days assessed through review of patient medical notes and/or data-linkage with nationally held death registrations (clinical effectiveness) 2. Incremental costs, quality-adjusted life years and net monetary benefit assessed using age-appropriate Pediatric Quality of Life Inventory (Peds-QL) and the Child Health Utility 9D (CHU-9D) at 12 months (cost effectiveness) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 09/11/2022: 1. Incremental costs calculated from patient-level resource data, length of stay in PICU/HDU and acute hospital for the index admission and any re-admission before 30 days after randomisation 2. Mortality assessed via patient medical notes and/or data linkage with nationally held death registrations at PICU discharge, 30 days, 90 days and 12 months 3. Time to liberation from mechanical ventilation, defined as the time the child was extubated and remained so for the remainder of their PICU stay 4. Duration of organ support during the child’s PICU stay 5. Functional status at PICU discharge as assessed by a clinician using the Paediatric Cerebral Performance Category (PCPC) and Paediatric Overall Performance Category (POPC) scales using patient’s notes 6. Duration of PICU and hospital stay assessed through review of patient medical notes at PICU discharge and hospital discharge 7. HrQoL at 12 months, measured by the child, self-or parent-proxy reported PedsQL-4.0 and the Child Heath Utility 9D (CHU-9D) at 12 months post randomisation Previous secondary outcome measures: 1. Mortality assessed via patient medical notes and/or data linkage with nationally held death registrations at PICU discharge, 30 days, 90 days and 12 months 2. Time to liberation from mechanical ventilation defined as the time the child was extubated and remained so for the remainder of their PICU stay 3. Duration of organ support during the child’s PICU stay 4. Duration of PICU and hospital stay assessed through review of patient medical notes at PICU discharge and hospital discharge | — |
Countries
England, United Kingdom
Contacts
Public ContactPaul Mouncey
Outcome results
None listed