Topic: Medicines for Children Research Network
Conditions
Interventions
The three interventions are:
1. Standard cold, dry (unhumidified) oxygen therapy
2. Cold, humidified oxygen therapy
3. Warm, humidified oxygen therapy
Primary intervention: in the A&E department, eac
Sponsors
Alder Hey Children's Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients between 2 and 16 years of age attending A&E with a clinical diagnosis of acute severe or potentially life-threatening asthma according to the BTS/SIGN guidelines and who still require oxygen after initial standard nebuliser therapy. For children 6 years and older, severe asthma will be based on the following criteria being met: 1. Oxygen saturations less than 92% while breathing room air and one of either: 2. Being too breathless to talk in complete sentences 3. Heart rate greater than 120/min 4. Respiratory rate greater than 30/min 5. Use of accessory neck muscles For children aged 2 to 5 years of age, severe asthma will be based on the following criteria being met: 1. Oxygen saturations less than 92% while breathing room air and one of either: 2. Being too breathless to talk or eat 3. Heart rate greater than 130/min 4. Respiratory rate greater than 50/min 5. Use of accessory neck muscles
Exclusion criteria
Exclusion criteria: 1. Requiring admission to intensive care at time of recruitment 2. Previous participation in this iteration of the Humox study 3. Other significant respiratory disease (chronic lung disease of prematurity, previous significant chest infections) 4. Any other significant underlying medical problem (immunodeficiency, neurological and cardiac conditions) 5. Previously or currently involved with a trial of a medicinal product in the three months preceding screening 6. Parents/guardians who are unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Length of time continuously spent in oxygen 2. Time until treatment ?stepped down? to hourly, two-hourly and four-hourly nebuliser therapy 3. Differences in oxygen saturation in air at set time points after entry into the study 4. Changes in Yung?s Asthma Severity Score and in the Pediatric Respiratory Assessment Measure 5. Number of Salbutamol and Ipratropium Bromide nebules required by each patient following randomisation 6. Requirement for escalation of treatment (i.e. need for intravenous salbutamol/aminophylline or HDU/PICU) 7. Adverse events/tolerability 8. Length of stay in hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed