Acute respiratory failure in immune impaired children Respiratory Chronic respiratory failure
Conditions
Interventions
Current interventions as of 07/07/2014:
Intervention group
Participants allocated to the intervention group will be admitted to the PICU and receive Continuous Positive
Sponsors
Great Ormond Street Hospital for Children NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 07/07/2014: 1. Age less than 18 years 2. Expected to have impaired immunity for at least 3 months as a result of a primary diagnosis, therapy or a combination of both 3. Acute respiratory failure or acute on chronic respiratory failure Previous inclusion criteria: 1. Age less than 16 years 2. Expected to have impaired immunity for at least 3 months as a result of a primary diagnosis, therapy or a combination of both 3. Acute respiratory failure or acute on chronic respiratory failure
Exclusion criteria
Exclusion criteria: 1. Already receiving invasive mechanical ventilation for non-respiratory indications 2. Other acute indication for emergency PICU admission and invasive mechanical ventilation, independent of the degree of respiratory failure (e.g., shock, reduced level of consciousness, seizures), as assessed by the PICU team 3. Recent oesophageal/gastric surgery 4. End-of-life care plan in place with limitation of resuscitation 5. Life expectancy less than 12 months 6. Already receiving treatment on PICU
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Requirement for intubation and invasive mechanical ventilation within 30 days post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maximum and aggregate daily organ failure score 2. Mortality at 30 days post-randomisation 3. Requirement for Level 2 or Level 3 respiratory support within 30 days post-randomisation 4. Days free from any ventilator support at 30 days post-randomisation 5. Days free from supplemental oxygen (i.e., above pre-acute respiratory failure requirement) at 30 days post-randomisation 6. Hospital mortality 7. Mortality at 90 days post-randomisation 8. Mortality 1 year post-randomisation | — |
Countries
United Kingdom
Outcome results
None listed