To assess whether humidified oxygen is more effective than standard oxygen therapy in treating children with acute severe asthma
| ISRCTN | ISRCTN62616194 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62616194 |
| Secondary identifying numbers | 15768 |
- Submission date
- 21/11/2013
- Registration date
- 21/11/2013
- Last edited
- 15/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
About one third of children admitted to hospital with asthma need oxygen and there are very good reasons why this oxygen should be warmed and humidified. This is to prevent airways becoming blocked with dried-up mucus and airway secretions. However, despite this, almost all children (and adults) seen in Accident & Emergency departments nationwide are routinely given cold (15°C), dry oxygen straight from the wall at the patients bedside. Following transfer to medical wards, practices vary around the country, but most children continue to receive cold, dry oxygen. Of them, many children with asthma complain of sore, dry noses and throats (and even nosebleeds) when given oxygen in hospital because of its dehydrating effects on the airway.
We want to assess whether giving humidified oxygen (either heated or unheated) from the time of admission to hospital, is more effective than the current standard of cold, dry oxygen therapy.
Who can participate?
Children (2-16 years) with acute severe asthma, admitted in any of the participating hospitals can take part in this study.
What does the study involve?
Patients will be randomly divided to receive one of the following three treatments: standard oxygen therapy, cold humidified oxygen therapy or warm humidified oxygen therapy. Various parameters including side effects and length of the stay in hospital will be assessed.
What are the possible benefits and risks of participating?
There are no benefits or risks associated with taking part in this study and we are not aware of any significant ethical issues raised by being involved in this study.
Where is the study run from?
The study is run from four hospitals in the North-West of England (Alder Hey, Arrowe Park, Warrington, Chester).
When is the study starting and how long is it expected to run for?
The study started in November 2013 and is expected to run until September 2016.
Who is funding the study?
The study is funded by the National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Paul McNamara
mcnamp@liv.ac.uk
Contact information
Scientific
Royal Liverpool Children's Hospital NHS Trust
Alder Hey Hospital
Eaton Road West Derby
Liverpool
L12 2AP
United Kingdom
| Phone | 123456789 |
|---|---|
| mcnamp@liv.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A pilot study to assess whether humidified oxygen is more effective than standard oxygen therapy in treating children with acute severe asthma |
| Study acronym | Humox Study |
| Study objectives | Current study hypothesis as of 15/05/2018: 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. This will enable us to plan a larger definitive multicentre study with a definitive primary outcome measure, sample size and robust data to inform recruitment rate in the population and setting under study. Previous study hypothesis: 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 multicentre study with a definitive primary outcome measure, sample size and robust data to inform recruitment rate in the population and setting under study. |
| Ethics approval(s) | NRES Committee North West - Liverpool East, 01/11/2013, 13/NW/0738 |
| Health condition(s) or problem(s) studied | Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases |
| Intervention | 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, each child will be randomised to receive one of the above three treatments. Heated humidified oxygen will be delivered by a Fisher & Paykel MR850 humidifier and a RT408 OxygenTherapy System through a System facemask (No 1120 or 1100 depending on patient size). The humidifier will be set to a temperature of 31°C and the percentage inspired oxygen titrated to maintain the patients oxygen saturations above 92%. The humidifier will be filled with sterile water. |
| Intervention type | Other |
| Primary outcome measure | 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 Yungs 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 outcome measures | Not provided at time of registration |
| Overall study start date | 25/11/2013 |
| Completion date | 01/04/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 90; UK Sample Size: 90 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2014 |
| Date of final enrolment | 01/12/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
L12 2AP
United Kingdom
Sponsor information
Hospital/treatment centre
Alder Hey Hospital
Eaton Road West Derby
Liverpool
L12 2AP
England
United Kingdom
"ROR" |
https://ror.org/04z61sd03 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
15/05/2018: The following changes have been made:
1. The overall trial end date has been changed from 01/09/2016 to 01/04/2017.
2. The study hypothesis has been changed.
14/05/2018: The recruitment start date has been changed from 25/11/2013 to 01/06/2014.
10/05/2018: The recruitment end date has been changed from 01/09/2016 to 01/12/2016.
