Condition category
Respiratory
Date applied
15/06/2016
Date assigned
17/06/2016
Last edited
21/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 risk factors from participating in this study as the oxygen levels are always kept in the normal range in both groups. There are also no direct benefits from participating in this study.

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

Contact information

Type

Public

Primary contact

Dr Bhavi Patel

ORCID ID

Contact details

The Children's Hospital at Montefiore
3415 Bainbridge Avenue
Bronx
New York
10467
United States of America

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, 4/22/2015, ref: 2015-4431

Study design

Single centered randomized prospective, double blinded clinical trial

Primary study design

Interventional

Secondary study design

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

Sponsor information

Organisation

Pediatric Critical Care Department

Sponsor details

3415 Bainbrige Avenue
Bronx
New York
10467
United States of America

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

21/06/2016: Internal reivew