Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2015-4431
Study information
Scientific title
Randomized clinical trial of high concentration oxygen therapy versus titrated oxygen therapy in pediatric asthma exacerbation
Acronym
Study hypothesis
High concentration oxygen leads to rise in transcutaneous carbon dioxide in acute exacerbation of asthma in the pediatric population.
Ethics approval
Albert Einstein College of Medicine Institutional Board Review, 22/04/2015, ref: 2015-4431
Study design
Single-center randomized prospective double-blind clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/12/2013
Overall trial end date
18/05/2016
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
104
Participant 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
Recruitment start date
01/08/2015
Recruitment end date
18/05/2016
Locations
Countries of recruitment
United States of America
Trial participating centre
The Children's Hospital at Montefiore
3415 Bainbridge Avenue
Bronx
New York
10467
United States of America
Funders
Funder type
Hospital/treatment centre
Funder name
Department of Pediatric Critical Care at the Children's Hospital at Montefiore (CHAM)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Hope to get manuscript published in the next 6 months.
Intention to publish date
31/12/2016
Participant level data
Not expected to be available
Results - basic reporting
Publication summary