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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
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Scientific title
Response of Patients with Neuromuscular Disease to Hyperoxia and Normoxia, as Measured by Carbon Dioxide Levels
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Secondary ID [1]
280264
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Nil
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Universal Trial Number (UTN)
U1111-1129-6717
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neuromuscular Disease
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Condition category
Condition code
Neurological
286423
286423
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0
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Other neurological disorders
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Musculoskeletal
286424
286424
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
284611
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Treatment: Other
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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.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Transcutaneous carbon dioxide level, adjusted for baseline, as measured by a TOSCA monitor.
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Assessment method [1]
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Timepoint [1]
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30 minutes.
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Secondary outcome [1]
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Transcutaneous carbon dioxide level, adjusted for baseline, as measured by a TOSCA monitor.
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Assessment method [1]
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Timepoint [1]
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10 and 20 minutes.
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Secondary outcome [2]
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Minute ventilation, adjusted for baseline, calculated using a flow sensor attached to the expiratory port of the participant's mask.
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Assessment method [2]
296849
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Timepoint [2]
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10, 20 and 30 minutes.
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Secondary outcome [3]
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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.
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Assessment method [3]
296850
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Timepoint [3]
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10, 20 and 30 minutes.
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Secondary outcome [4]
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Change in transcutaneous carbon dioxide greater than or equal to 4mmHg, as measured by a TOSCA monitor.
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Assessment method [4]
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Timepoint [4]
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30 minutes.
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Secondary outcome [5]
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Change in transcutaneous carbon dioxide greater than or equal to 10mmHg, as measured by a TOSCA monitor.
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Assessment method [5]
296852
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Timepoint [5]
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30 minutes.
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Secondary outcome [6]
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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.
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Assessment method [6]
296853
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Timepoint [6]
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10, 20 and 30 minutes.
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Secondary outcome [7]
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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.
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Assessment method [7]
296854
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Timepoint [7]
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10, 20 and 30 minutes.
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Secondary outcome [8]
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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.
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Assessment method [8]
296855
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Timepoint [8]
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10, 20 and 30 minutes.
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Secondary outcome [9]
296856
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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.
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Assessment method [9]
296856
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Timepoint [9]
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10, 20 and 30 minutes.
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Secondary outcome [10]
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Oxygen saturations, adjusted for baseline, as recorded on the TOSCA via continuous electronic recording data download.
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Assessment method [10]
296857
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Timepoint [10]
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Continuously over the time course of the intervention and washout period.
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Secondary outcome [11]
296858
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Effect of baseline transcutaneous carbon dioxide, as recoded on the TOSCA, on outcome.
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Assessment method [11]
296858
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Timepoint [11]
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Value from baseline.
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Secondary outcome [12]
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Heart rate, adjusted for baseline, as recoded on the TOSCA.
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Assessment method [12]
296859
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Timepoint [12]
296859
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10, 20 and 30 minutes.
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Secondary outcome [13]
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Respiratory rate, adjusted for baseline, measured from capnography equipment.
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Assessment method [13]
296860
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Timepoint [13]
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10, 20 and 30 minutes.
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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.
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Minimum age
14
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By computer.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
18/04/2012
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Actual
13/09/2012
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Date of last participant enrolment
Anticipated
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Actual
5/01/2015
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
24
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Accrual to date
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Final
24
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Recruitment outside Australia
Country [1]
4234
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New Zealand
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State/province [1]
4234
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Health Research Council of New Zealand
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Address [1]
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Level 3- ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland, 1010
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Country [1]
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New Zealand
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Medical Research Institute of New Zealand
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Address [2]
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MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country [2]
285022
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New Zealand
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Primary sponsor type
Individual
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Name
Janine Pilcher
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Address
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country
New Zealand
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Secondary sponsor category [1]
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Individual
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Name [1]
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Richard Beasley
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Address [1]
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MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country [1]
283887
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New Zealand
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Other collaborator category [1]
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Individual
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Name [1]
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Hamish Collie
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Address [1]
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Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country [1]
260683
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New Zealand
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Other collaborator category [2]
260684
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Individual
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Name [2]
260684
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Kyle Perrin
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Address [2]
260684
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MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country [2]
260684
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New Zealand
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Other collaborator category [3]
260685
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Individual
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Name [3]
260685
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Pip Shirtcliffe
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Address [3]
260685
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MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country [3]
260685
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New Zealand
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Other collaborator category [4]
260686
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Individual
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Name [4]
260686
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Mitesh Patel
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Address [4]
260686
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MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country [4]
260686
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New Zealand
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Other collaborator category [5]
260687
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Individual
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Name [5]
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Mathew Williams
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Address [5]
260687
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MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country [5]
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New Zealand
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Other collaborator category [6]
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Individual
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Name [6]
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Mark Weatherall
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Address [6]
260688
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Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country [6]
260688
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New Zealand
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Other collaborator category [7]
260695
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Individual
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Name [7]
260695
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Irene Braithewaite
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Address [7]
260695
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Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country [7]
260695
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Health and Disability Ethics Committee: Central
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Ethics committee address [1]
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1 The Terrace, Wellington, 6011
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Ethics committee country [1]
287023
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New Zealand
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Date submitted for ethics approval [1]
287023
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11/10/2011
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Approval date [1]
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30/03/2012
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Ethics approval number [1]
287023
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CEN/11/11/065
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Summary
Brief summary
Oxygen therapy has been shown to increase carbon dioxide in the blood of patients with certain respiratory conditions. This study aims to find out if oxygen therapy increases carbon dioxide levels in patients with neuromuscular disease and, if so, how.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
34011
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Dr Janine Pilcher
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Address
34011
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MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country
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New Zealand
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Phone
34011
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+64 4 8050241
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Fax
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Email
34011
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[email protected]
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Contact person for public queries
Name
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Dr Janine Pilcher
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Address
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MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country
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New Zealand
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Phone
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+64 4 8050241
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Fax
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+64 4 3895707
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Janine Pilcher
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Address
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MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country
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New Zealand
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Phone
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+64 4 8050241
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Fax
8186
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+64 4 3895707
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Email
8186
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[email protected]
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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
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4351
Thesis
No
https://researcharchive.vuw.ac.nz/xmlui/handle/100...
[
More Details
]
Documents added automatically
No additional documents have been identified.
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