Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000549325
Ethics application status
Approved
Date submitted
11/06/2008
Date registered
30/10/2008
Date last updated
9/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of breathing oxygen in patients with asthma.
Scientific title
The effect of high flow oxygen on carbon dioxide levels and ventilation in patients with chronic stable asthma.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 3209 0
Condition category
Condition code
Respiratory 3374 3374 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
100% oxygen inhaled for 20 minutes through a CPAP mask and tubing. Intervention will be administered to 3 groups of subjects: 1. 18 subjects with Asthma 2. 18 subjects with Chronic Obstructive Pulmonary Disease 3. 18 normal subjects (no respiratory disease)
Intervention code [1] 2993 0
Treatment: Other
Comparator / control treatment
The same treatment (100% oxygen inhaled for 20 minutes through a CPAP mask and tubing) will be given to the 2 control groups: normal subjects and a group of Chronic Obstructive Pulmonary Disease (COPD) subjects
Control group
Active

Outcomes
Primary outcome [1] 4264 0
Change in PaCO2 measured by a transcutaneous CO2 monitor clipped to the earlobe
Timepoint [1] 4264 0
After 20 minutes of 100% oxygen inhalation
Secondary outcome [1] 7200 0
Change in ratio of physiological dead space:tidal volume calculated by measuring the mixed exhaled CO2 through a sensor in the mask mouthpiece
Timepoint [1] 7200 0
After 20 minutes of oxygen inhalation
Secondary outcome [2] 262174 0
Change in minute ventilation (in litres per minute) measured by a flow-meter attached to the mask mouthpiece
Timepoint [2] 262174 0
After 20 minutes of 100% oxygen inhalation

Eligibility
Key inclusion criteria
1. Diagnosis of asthma
2. Forced Expiratory Volume in one second (FEV1) < or = 60% predicted
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Diagnosis of COPD
2. Current or ex cigarette smoking of > 10 pack years
3. Risk factors for hypercapnic respiratory failure (Body Mass Index > 40, severe musculoskeletal weakness, chest wall restriction).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 995 0
New Zealand
State/province [1] 995 0

Funding & Sponsors
Funding source category [1] 3439 0
Government body
Name [1] 3439 0
Health Research Council
Country [1] 3439 0
New Zealand
Primary sponsor type
Individual
Name
Kyle Perrin
Address
MRINZ
Level 3
99 The terrace
Wellington
Country
New Zealand
Secondary sponsor category [1] 3081 0
None
Name [1] 3081 0
Address [1] 3081 0
Country [1] 3081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5463 0
Central Regional Ethics Committee
Ethics committee address [1] 5463 0
Ministry of Health
1 - 3 The Terrace
PO Box 5013
Wellington
Ethics committee country [1] 5463 0
New Zealand
Date submitted for ethics approval [1] 5463 0
19/03/2008
Approval date [1] 5463 0
20/05/2008
Ethics approval number [1] 5463 0
CEN/08/04/013

Summary
Brief summary
It is well known that high amounts of oxygen can be harmful to patients with emphysema when they come to the emergency department. There is also a small amount of research to suggest that it could be harmful to patients with severe asthma as well, although they are routinely given high flow oxygen. The main purpose of this study is to see if giving 100% oxygen to asthmatics causes a rise in harmful carbon dioxide, and if so, what is the mechanism?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28630 0
Address 28630 0
Country 28630 0
Phone 28630 0
Fax 28630 0
Email 28630 0
Contact person for public queries
Name 11787 0
Kyle Perrin
Address 11787 0
MRINZ
Level 3
99 The terrace
Wellington
Country 11787 0
New Zealand
Phone 11787 0
+64 4 4729120
Fax 11787 0
Email 11787 0
[email protected]
Contact person for scientific queries
Name 2715 0
Kyle Perrin
Address 2715 0
MRINZ
Level 3
99 The terrace
Wellington
Country 2715 0
New Zealand
Phone 2715 0
+64 4 4729120
Fax 2715 0
Email 2715 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.