Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000970549
Ethics application status
Approved
Date submitted
3/09/2015
Date registered
16/09/2015
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Date results information initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
High Concentration Oxygen in Neuromuscular Disease: Study 2
Scientific title
Response of Patients with Neuromuscular Disease to Hyperoxia and Normoxia, as Measured by Carbon Dioxide Levels: Study 2
Secondary ID [1] 287409 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 296114 0
Kyphoscoliosis 296163 0
Condition category
Condition code
Neurological 296373 296373 0 0
Other neurological disorders
Musculoskeletal 296374 296374 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] 292761 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] 296018 0
Transcutaneous carbon dioxide level, adjusted for baseline, as measured by a Sentec monitor.
Timepoint [1] 296018 0
30 minutes.
Secondary outcome [1] 317239 0
Transcutaneous carbon dioxide level, adjusted for baseline, as measured by a Sentec monitor.
Timepoint [1] 317239 0
10 and 20 minutes.
Secondary outcome [2] 317240 0
Minute ventilation, adjusted for baseline, calculated using a flow sensor attached to the expiratory port of the participant's mask.
Timepoint [2] 317240 0
10, 20 and 30 minutes.
Secondary outcome [3] 317241 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] 317241 0
10, 20 and 30 minutes.
Secondary outcome [4] 317242 0
Change in transcutaneous carbon dioxide greater than or equal to 4mmHg, as measured by a Sentec monitor.
Timepoint [4] 317242 0
30 minutes.
Secondary outcome [5] 317243 0
Change in transcutaneous carbon dioxide greater than or equal to 10mmHg, as measured by a Sentec monitor.
Timepoint [5] 317243 0
30 minutes.
Secondary outcome [6] 317244 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] 317244 0
10, 20 and 30 minutes.
Secondary outcome [7] 317245 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] 317245 0
10, 20 and 30 minutes.
Secondary outcome [8] 317246 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] 317246 0
10, 20 and 30 minutes.
Secondary outcome [9] 317247 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] 317247 0
10, 20 and 30 minutes.
Secondary outcome [10] 317248 0
Oxygen saturations, adjusted for baseline, as recorded on the Sentec via continuous electronic recording data download.
Timepoint [10] 317248 0
Continuously over the time course of the intervention and washout period.
Secondary outcome [11] 317249 0
Effect of baseline transcutaneous carbon dioxide, as recorded on the Sentec, on outcome.
Timepoint [11] 317249 0
Value from baseline.
Secondary outcome [12] 317250 0
Heart rate, adjusted for baseline, as recorded on the Sentec.
Timepoint [12] 317250 0
10, 20 and 30 minutes.
Secondary outcome [13] 317251 0
Respiratory rate, adjusted for baseline, measured from capnography equipment.
Timepoint [13] 317251 0
10, 20 and 30 minutes.
Secondary outcome [14] 317252 0
End tidal carbon dioxide, calculated using the capnography sensor attached to expiratory port of participant's mask.
Timepoint [14] 317252 0
10, 20 and 30 minutes.
Secondary outcome [15] 317253 0
Transcutaneous carbon dioxide level as measured by Sentec and with drift correction by Sentec computer software
Timepoint [15] 317253 0
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 explanation 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). The unblinded investigator will 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 blinded investigator (who will record outcome data) 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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/09/2015
Actual
13/10/2015
Date of last participant enrolment
Anticipated
Actual
30/05/2017
Date of last data collection
Anticipated
Actual
30/05/2017
Sample size
Target
24
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 7135 0
New Zealand
State/province [1] 7135 0

Funding & Sponsors
Funding source category [1] 291973 0
Government body
Name [1] 291973 0
Health Research Council of New Zealand
Country [1] 291973 0
New Zealand
Funding source category [2] 291974 0
Charities/Societies/Foundations
Name [2] 291974 0
Medical Research Institute of New Zealand
Country [2] 291974 0
New Zealand
Primary sponsor type
Individual
Name
Janine Pilcher
Address
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 290640 0
Individual
Name [1] 290640 0
Richard Beasley
Address [1] 290640 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [1] 290640 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293468 0
Health and Disability Ethics Committee
Ethics committee address [1] 293468 0
20 Aitken Street
Wellington 6011
Ethics committee country [1] 293468 0
New Zealand
Date submitted for ethics approval [1] 293468 0
Approval date [1] 293468 0
30/03/2012
Ethics approval number [1] 293468 0
CEN/11/11/065

Summary
Brief summary
This study directly relates to the trial
ACTRN12612000393853. As there is concern regarding the accuracy of the data collected by the specific transcutaneous probes used with that study (measuring carbon dioxide, oxygen levels and heart rate), the study is being repeated using a Sentec transcutaneous monitor. The Ethics approval number and UTN remain the same, however ANZCTR required a new trial registration number. Two new outcome measures have been added (end tidal carbon dioxide, to further assess the mechanisms behind any change in carbon dioxide, and drift corrected carbon dioxide (a function of the Sentec monitor to improve accuracy)).


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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60050 0
Dr Janine Pilcher
Address 60050 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 60050 0
New Zealand
Phone 60050 0
+6448050147
Fax 60050 0
Email 60050 0
janine.pilcher@mrinz.ac.nz
Contact person for public queries
Name 60051 0
Dr Janine Pilcher
Address 60051 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 60051 0
New Zealand
Phone 60051 0
+6448050147
Fax 60051 0
Email 60051 0
janine.pilcher@mrinz.ac.nz
Contact person for scientific queries
Name 60052 0
Dr Janine Pilcher
Address 60052 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 60052 0
New Zealand
Phone 60052 0
+6448050147
Fax 60052 0
Email 60052 0
janine.pilcher@mrinz.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
Study results articleYes Pilcher J, Thayabaran D, Ebmeier S, Williams M, Ba... [More Details]
ThesisNo https://researcharchive.vuw.ac.nz/xmlui/handle/100... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of 50% oxygen on PtCO2 in patients with stable COPD, bronchiectasis, and neuromuscular disease or kyphoscoliosis: Randomised cross-over trials.2020https://dx.doi.org/10.1186/s12890-020-1132-z
N.B. These documents automatically identified may not have been verified by the study sponsor.