High concentration oxygen therapy in pediatric asthma exacerbation
| ISRCTN | ISRCTN48562837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48562837 |
| Secondary identifying numbers | 2015-4431 |
- Submission date
- 15/06/2016
- Registration date
- 17/06/2016
- Last edited
- 17/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Asthma Is a common long term health condition caused by inflammation of the bronchi, small tubes that carry air in and out of the lungs. The airways can become narrow if the sufferer comes into something that “triggers” their asthma – for example animal fur, pollen, viral infection and exercise. This can cause symptoms such as coughing, wheezing, tightness of the chest and feeling breathless. Occasionally, asthma symptoms can gradually or suddenly get much worse. This is called an asthma attack. Severe attacks may require hospital treatment and, in extreme cases, can even lead to death. This study is looking at the use of oxygen in children who are having an asthma attack. The researchers are investigating whether the amount of oxygen used affects the carbon dioxide in children suffering from an asthma attack and whether it makes their asthma worse and/or results in their hospitalization.
Who can participate?
Children 2-18 years of age suffering from a moderate to severe asthma attack and are coming to the emergency room (ED)
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 receive 100% oxygen as part of their treatment. Those in group 2 receive titrated oxygen to keep that oxygen level between 92 to 95% while they are receiving their nebulization treatments.
What are the possible benefits and risks of participating?
There are no direct benefits from participating in this study. There are no risks from participating in this study as the oxygen levels are always kept in the normal range in both groups.
Where is the study run from?
The Children's Hospital at Montefiore, Bronx, New York (USA)
When is study starting and how long is it expected to run for?
December 2013 to May 2016
Who is funding the study?
Pediatric Critical Care Division, Children's Hospital at Montefiore (USA)
Who is the main contact?
Dr Bhavi Patel
Contact information
Public
The Children's Hospital at Montefiore
3415 Bainbridge Avenue
Bronx
New York
10467
United States of America
Study information
| Study design | Single-center randomized prospective double-blind clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Randomized clinical trial of high concentration oxygen therapy versus titrated oxygen therapy in pediatric asthma exacerbation |
| Study objectives | High concentration oxygen leads to rise in transcutaneous carbon dioxide in acute exacerbation of asthma in the pediatric population. |
| Ethics approval(s) | Albert Einstein College of Medicine Institutional Board Review, 22/04/2015, ref: 2015-4431 |
| Health condition(s) or problem(s) studied | Pediatric asthma exacerbation |
| Intervention | Children 2 to 18 years with previously diagnosed asthma with moderate to severe asthma exacerbation (asthma score > 5) were randomized to high concentration oxygen therapy (100% oxygen via face mask at >4L/min) or titrated oxygen therapy (titrated up from 21% via a blender continuously) to maintain saturations between 92 to 95% while receiving their nebulized treatments. Randomization was based on computer randomization sequence program generated by the biostatistician. |
| Intervention type | Other |
| Primary outcome measure | Rise in transcutaneous carbon dioxide, measured via a transcutaneous carbon dioxide monitor at 0, 20, 40, 60 minutes and then every 30 minutes till disposition decision was reached by the ED physician |
| Secondary outcome measures | 1. Change of > 4 mmHg PtCO2 and > 38 mmHg PtCO2 measured via a transcutaneous Co2 monitor at 0, 20, 40, 60 minutes and then every 30 minutes till disposition decision was reached by the ED physician 2. Change in asthma score, measured via a validated respiratory score tool used by the hospital as part of the asthma treatment pathway at 0, 20, 40, 60 minutes and then every 30 minutes till disposition decision was reached by the ED physician 3. Admission rates |
| Overall study start date | 01/12/2013 |
| Completion date | 18/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 104 |
| Key inclusion criteria | Patients between 2 to 18 years with previous medical diagnosis of asthma presenting with moderate to severe asthma exacerbation with asthma score > 5 |
| Key exclusion criteria | 1. Disorders with hypercapnic respiratory failure such as neuromuscular disease, chest wall restriction, or obesity hypoventilation 2. Unconscious patient 3. Pregnancy 4. Receiving sedatives/depressants 5. History of congenital heart disease 6. Disease of cardiac, renal, or hepatic systems 7. History of smoking |
| Date of first enrolment | 01/08/2015 |
| Date of final enrolment | 18/05/2016 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Bronx
New York
10467
United States of America
Sponsor information
Hospital/treatment centre
3415 Bainbridge Avenue
Bronx
New York
10467
United States of America
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Hope to get manuscript published in the next 6 months. |
| IPD sharing plan |
Editorial Notes
17/05/2017: Internal review.
