Humox Study
Research type
Research Study
Full title
A pilot study to assess whether humidified oxygen is more effective that standard oxygen therapy in treating children with acute severe asthma
IRAS ID
138220
Contact name
Paul McNamara
Contact email
Sponsor organisation
Alder Hey Children's Hospital
Research summary
In the UK, there are 1.1 million children (1-in-11) with asthma. Every year, 30,000 attend hospital with this condition, with approximately one third of those children hospitalised need oxygen. Normally when we breathe, air is warmed and humidified in our upper airways and there are very good reasons why anyone with acute severe asthma should also have their oxygen therapy warmed and humidified. This is to prevent their airways becoming more blocked with dried-up mucus and airway secretions. However, when children (and adults) are seen in A&E departments, they are routinely given cold (15 0C), dry (un-humidified) oxygen straight from the wall at the patient bedside. Following transfer to medical wards, most children continue to be treated with cold, dry oxygen, although is a bit of a lottery as nationwide practice varies considerably.
To determine the most effective treatment for children admitted to hospital with severe asthma, we propose a pilot, randomised controlled trial in which participants will receive either: standard oxygen therapy; warm humidified oxygen; cold humidified oxygen. A range of outcomes will be measured which have previously been assessed as relevant and important by consumers and clinicians. The pilot study will establish which outcome measures can be successfully measured, and provide estimates of effect sizes for these outcomes; a consensus exercise will establish which outcome measure(s) is most relevant and important to consumers and clinicians. A health economic assessment will investigate the feasibility of collecting the relevant data required to calculate differences in Quality Adjusted Life Years (QALYs) in a definitive study. This will enable us to plan a larger definitive multi-centre study with a definitive primary outcome measure, sample size and robust data to inform recruitment rate in the population and setting under study.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0738
Date of REC Opinion
22 Oct 2013
REC opinion
Favourable Opinion