Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000172303
Ethics application status
Approved
Date submitted
27/03/2008
Date registered
8/04/2008
Date last updated
22/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of supplemental oxygen in patients with chronic hypercapnic respiratory failure
Scientific title
Ventilatory and haemodynamic responses to supplemental oxygen in patients with chronic hypercapnic respiratory failure
Secondary ID [1] 262591 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic hypercapnic respiratory failure due to obesity hypoventilation syndrome 2980 0
Condition category
Condition code
Respiratory 3127 3127 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During a testing session, participants will breathe supplemental oxygen at 2 concentrations (fraction of inspired oxygen 28% and 50%) for 20 minutes each. There will be a one-hour washout period between interventions. A group of healthy control participants will be tested on only one occasion to allow us to document the normal response to 28% and 50% oxygen. Participants with hypercapnic respiratory failure will perform testing on two occasions: once at initial presentation with untreated hypercapnic respiratory failure; and once after three months of treatment with nocturnal positive airway pressure therapy. Nocturnal positive airway pressure will be prescribed and implemented in accordance with usual clinical practice at our centre. Some data collected as part of this study will also be used for two measurement validation studies. The first study is investigating the validity of arterialised venous blood gases against gold standard acid-base measures obtained from arterial blood gases. A single pair of simultaneously taken arterialised venous and arterial blood samples taken during each testing session will used for this validation. The second study is investigating the validity of respiratory inductive plethysmography in people with obesity hypoventilation syndrome and healthy controls. Simultaneous repeated measurements of tidal volume, minute ventilation, and respiratory rate measured by the air/oxygen breathing circuit and a non-invasive respiratory inductance vest will be compared for this validation study.
Intervention code [1] 2719 0
Treatment: Other
Comparator / control treatment
This is a crossover trial in which each participant will receive supplemental oxygen at 2 concentrations (fraction of inspired oxygen 28% and 50%). Each participant will therefore act as their own control in the comparison between 28% and 50% oxygen. A group of healthy participants (age and gender matched to each participant with chronic hypercapnic respiratory failure) will also be recruited into the study to document the normal response to 28% and 50% oxygen.
Control group
Active

Outcomes
Primary outcome [1] 4012 0
Arterialised venous carbon dioxide
Timepoint [1] 4012 0
Baseline, at 5 minute intervals during treatment time of 20 minutes, and 10 minutes after treatment
Secondary outcome [1] 6750 0
Minute ventilation
Timepoint [1] 6750 0
Baseline, at 5 minute intervals during 20 minute treatment and 10 minutes after treatment

Eligibility
Key inclusion criteria
Chronic hypercapnic respiratory failure due to obesity hypoventilation syndrome or neuromuscular disease
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute respiratory failure or recent respiratory illness,
Obstructive pulmonary disease,
Pregnancy,
Unstable cardiac condition,
Psychiatric illness,
Non-english speaking

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients referred to the department of sleep medicine, Royal Prince Alfred Hospital (RPAH) for the management of chronic hypercapnic respiratory failure will be screened for eligibility. Healthy control participants will be recruited from a sample of cenvenience on the basis of age and gender matching for each participant with chronic hypercapnic respiratory failure. Eligible people will be verbally approached by the investigators and will be provided with an information for participants handout. The study is a randomised crossover design, so the two concentrations of oxygen will be given to each subject in random order. Order of intervention for each subject will be generated randomly and placed in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Order of treatment will be written in an opaque sealed envelope for each subject. This order will be generated via the website www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3244 0
Hospital
Name [1] 3244 0
Royal Prince Alfred Hospital
Country [1] 3244 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Sleep Unit 11West
Missenden Road
CAMPERDOWN 2050
Country
Australia
Secondary sponsor category [1] 2900 0
University
Name [1] 2900 0
The University of Sydney
Address [1] 2900 0
75 East Street
P.O. Box 170
LIDCOMBE NSW 1825
Country [1] 2900 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5227 0
Sydney South West Area Health Service Ethics Review Committee (RPA Zone)
Ethics committee address [1] 5227 0
Research Development Office
Level 8, Building 14
Royal Prince Alfred Hospital
CAMPERDOWN NSW 2050
Ethics committee country [1] 5227 0
Australia
Date submitted for ethics approval [1] 5227 0
23/01/2008
Approval date [1] 5227 0
10/03/2008
Ethics approval number [1] 5227 0
08/RPAH/53

Summary
Brief summary
In medical practice and published research, it is well documented that in some patients with respiratory failure due to chronic lung disease, breathing high concentrations of oxygen can cause carbon dioxide levels to increase, sometimes to potentially harmful levels. The effect of oxygen on patients who have chronic respiratory failure from other causes such as obesity hypoventilation syndrome is less clear. We would like to test the effect of two concentrations of oxygen on breathing pattern and carbon dioxide levels in patients who have chronic respiratory failure due to obesity hypoventilation syndrome. We expect that breathing high concentration oxygen will cause an increase in carbon dioxide levels and alter breathing pattern in this group. It has also been proposed that this group, treating (and reversing) hypercapnia through the use of nocturnal positive airway pressure therapy may improve responsiveness to carbon dioxide, thereby minimising the potentially harmful effects of supplemental oxygen. We hypothesised that three months of treatment with nocturnal positive airway pressure would lessen any adverse responses to supplemental oxygen observed during testing at initial presentation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28472 0
Address 28472 0
Country 28472 0
Phone 28472 0
Fax 28472 0
Email 28472 0
Contact person for public queries
Name 11629 0
Ms. Carly Hollier
Address 11629 0
Sleep Unit 11west
Royal Prince Alfred Hospital
Missenden Rd.
CAMPERDOWN NSW 2050
Country 11629 0
Australia
Phone 11629 0
(02) 9515 8708
Fax 11629 0
(02) 9515 7196
Email 11629 0
[email protected]
Contact person for scientific queries
Name 2557 0
Carly Hollier
Address 2557 0
Sleep Unit 11west
Royal Prince Alfred Hospital
Missenden Rd.
CAMPERDOWN NSW 2050
Country 2557 0
Australia
Phone 2557 0
(02) 9515 8708
Fax 2557 0
(02) 9515 7196
Email 2557 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.