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Trial registered on ANZCTR


Registration number
ACTRN12612000393853
Ethics application status
Approved
Date submitted
5/04/2012
Date registered
5/04/2012
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
High Concentration Oxygen in Neuromuscular Disease
Scientific title
Response of Patients with Neuromuscular Disease to Hyperoxia and Normoxia, as Measured by Carbon Dioxide Levels
Secondary ID [1] 280264 0
Nil
Universal Trial Number (UTN)
U1111-1129-6717
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuromuscular Disease 286212 0
Condition category
Condition code
Neurological 286423 286423 0 0
Other neurological disorders
Musculoskeletal 286424 286424 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
50% oxygen administration for 30 minutes via a full-face continuous positive airway pressure mask without positive airway pressure. Followed by a 30 minute washout period.
Intervention code [1] 284611 0
Treatment: Other
Comparator / control treatment
21% oxygen administration for 30 minutes via a full-face continuous positive airway pressure mask without positive airway pressure. Followed by a 30 minute washout period.
Control group
Placebo

Outcomes
Primary outcome [1] 286868 0
Transcutaneous carbon dioxide level, adjusted for baseline, as measured by a TOSCA monitor.
Timepoint [1] 286868 0
30 minutes.
Secondary outcome [1] 296846 0
Transcutaneous carbon dioxide level, adjusted for baseline, as measured by a TOSCA monitor.
Timepoint [1] 296846 0
10 and 20 minutes.
Secondary outcome [2] 296849 0
Minute ventilation, adjusted for baseline, calculated using a flow sensor attached to the expiratory port of the participant's mask.
Timepoint [2] 296849 0
10, 20 and 30 minutes.
Secondary outcome [3] 296850 0
Volume of dead space to tidal volume ratio, adjusted for baseline, calculated using additional data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [3] 296850 0
10, 20 and 30 minutes.
Secondary outcome [4] 296851 0
Change in transcutaneous carbon dioxide greater than or equal to 4mmHg, as measured by a TOSCA monitor.
Timepoint [4] 296851 0
30 minutes.
Secondary outcome [5] 296852 0
Change in transcutaneous carbon dioxide greater than or equal to 10mmHg, as measured by a TOSCA monitor.
Timepoint [5] 296852 0
30 minutes.
Secondary outcome [6] 296853 0
Tidal volume, adjusted for baseline, calculated using additional data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [6] 296853 0
10, 20 and 30 minutes.
Secondary outcome [7] 296854 0
Volume of dead space, adjusted for baseline, calculated using additional data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [7] 296854 0
10, 20 and 30 minutes.
Secondary outcome [8] 296855 0
Alveolar volume, adjusted for baseline, calculated using additional data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [8] 296855 0
10, 20 and 30 minutes.
Secondary outcome [9] 296856 0
Alveolar minute ventilation, adjusted for baseline, calculated using additional data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [9] 296856 0
10, 20 and 30 minutes.
Secondary outcome [10] 296857 0
Oxygen saturations, adjusted for baseline, as recorded on the TOSCA via continuous electronic recording data download.
Timepoint [10] 296857 0
Continuously over the time course of the intervention and washout period.
Secondary outcome [11] 296858 0
Effect of baseline transcutaneous carbon dioxide, as recoded on the TOSCA, on outcome.
Timepoint [11] 296858 0
Value from baseline.
Secondary outcome [12] 296859 0
Heart rate, adjusted for baseline, as recoded on the TOSCA.
Timepoint [12] 296859 0
10, 20 and 30 minutes.
Secondary outcome [13] 296860 0
Respiratory rate, adjusted for baseline, measured from capnography equipment.
Timepoint [13] 296860 0
10, 20 and 30 minutes.

Eligibility
Key inclusion criteria
Diagnosis of neuromuscular disease with a greater than or equal to 10% drop in vital capacity from standing to lying, or a sniff nasal inspiratory pressure under the lower limit (above which lie 95% of healthy subjects), based on work by Uldry and Fitting (Thorax 1995;50(4)).

OR

Kyphoscoliosis with an FVC <65% predicted.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Baseline transcutaneous carbon dioxide of greater than or equal to 60mmHg Diagnosis of chronic obstructive pulmonary disease FEV1:FVC ratio less than or equal to 70% (if participant able to perform forced spirometry) Obesity (with a body mass index of greater than or equal to 40) Any other condition which, at the investigator's discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.

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)
Following explaination of the trial and consent, participants will be assessed for eligibility. If eligible, participants will be randomised to the order of interventions (21% oxygen and 50% oxygen). This order will be available to an investigator who is not administering treatment, assessing outcomes or analysing data. Their role is to make available the gas bottles and bags (containing either 21% or 50% oxygen) in the randomised order. The labels on the bottles will be covered to maintain the blinding of other investigators and the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By computer.
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
Completed
Date of first participant enrolment
Anticipated
18/04/2012
Actual
13/09/2012
Date of last participant enrolment
Anticipated
Actual
5/01/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 4234 0
New Zealand
State/province [1] 4234 0

Funding & Sponsors
Funding source category [1] 285021 0
Government body
Name [1] 285021 0
Health Research Council of New Zealand
Country [1] 285021 0
New Zealand
Funding source category [2] 285022 0
Charities/Societies/Foundations
Name [2] 285022 0
Medical Research Institute of New Zealand
Country [2] 285022 0
New Zealand
Primary sponsor type
Individual
Name
Janine Pilcher
Address
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 283887 0
Individual
Name [1] 283887 0
Richard Beasley
Address [1] 283887 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [1] 283887 0
New Zealand
Other collaborator category [1] 260683 0
Individual
Name [1] 260683 0
Hamish Collie
Address [1] 260683 0
Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [1] 260683 0
New Zealand
Other collaborator category [2] 260684 0
Individual
Name [2] 260684 0
Kyle Perrin
Address [2] 260684 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [2] 260684 0
New Zealand
Other collaborator category [3] 260685 0
Individual
Name [3] 260685 0
Pip Shirtcliffe
Address [3] 260685 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [3] 260685 0
New Zealand
Other collaborator category [4] 260686 0
Individual
Name [4] 260686 0
Mitesh Patel
Address [4] 260686 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [4] 260686 0
New Zealand
Other collaborator category [5] 260687 0
Individual
Name [5] 260687 0
Mathew Williams
Address [5] 260687 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [5] 260687 0
New Zealand
Other collaborator category [6] 260688 0
Individual
Name [6] 260688 0
Mark Weatherall
Address [6] 260688 0
Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [6] 260688 0
New Zealand
Other collaborator category [7] 260695 0
Individual
Name [7] 260695 0
Irene Braithewaite
Address [7] 260695 0
Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [7] 260695 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287023 0
Health and Disability Ethics Committee: Central
Ethics committee address [1] 287023 0
Ethics committee country [1] 287023 0
New Zealand
Date submitted for ethics approval [1] 287023 0
11/10/2011
Approval date [1] 287023 0
30/03/2012
Ethics approval number [1] 287023 0
CEN/11/11/065

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34011 0
Dr Janine Pilcher
Address 34011 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 34011 0
New Zealand
Phone 34011 0
+64 4 8050241
Fax 34011 0
Email 34011 0
janine.pilcher@mrinz.ac.nz
Contact person for public queries
Name 17258 0
Janine Pilcher
Address 17258 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 17258 0
New Zealand
Phone 17258 0
+64 4 8050241
Fax 17258 0
+64 4 3895707
Email 17258 0
janine.pilcher@mrinz.ac.nz
Contact person for scientific queries
Name 8186 0
Janine Pilcher
Address 8186 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 8186 0
New Zealand
Phone 8186 0
+64 4 8050241
Fax 8186 0
+64 4 3895707
Email 8186 0
janine.pilcher@mrinz.ac.nz

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ThesisNo https://researcharchive.vuw.ac.nz/xmlui/handle/100... [More Details]

Documents added automatically
No additional documents have been identified.