To assess whether humidified oxygen is more effective than standard oxygen therapy in treating children with acute severe asthma

Not Applicable

Completed

• Conditions: Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases; Respiratory

• Registration Number: ISRCTN62616194
• Lead Sponsor: Alder Hey Children's Hospital (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-21
• Study Completion: 2017-04-01
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Length of time continuously spent in oxygen<br>2. Time until treatment ?stepped down? to hourly, two-hourly and four-hourly nebuliser therapy<br>3. Differences in oxygen saturation in air at set time points after entry into the study<br>4. Changes in Yung?s Asthma Severity Score and in the Pediatric Respiratory Assessment Measure<br>5. Number of Salbutamol and Ipratropium Bromide nebules required by each patient following randomisation<br>6. Requirement for escalation of treatment (i.e. need for intravenous salbutamol/aminophylline or HDU/PICU)<br>7. Adverse events/tolerability<br>8. Length of stay in hospital

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration