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Trial registered on ANZCTR


Registration number
ACTRN12615000971538
Ethics application status
Approved
Date submitted
4/09/2015
Date registered
16/09/2015
Date last updated
25/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
High Concentration Oxygen in Bronchiectasis or Cystic Fibrosis: Study 2
Scientific title
Response of Patients with Bronchiectasis or Cystic Fibrosis to Hyperoxia and Normoxia, as Measured by Carbon Dioxide Levels: Study 2
Secondary ID [1] 287410 0
Nil
Universal Trial Number (UTN)
U1111-1129-5351
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 296115 0
Cystic Fibrosis 296164 0
Condition category
Condition code
Respiratory 296375 296375 0 0
Other respiratory disorders / diseases

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] 292762 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] 296022 0
Transcutaneous carbon dioxide level, adjusted for baseline, as measured by a Sentec monitor.
Timepoint [1] 296022 0
30 minutes.
Secondary outcome [1] 317255 0
Transcutaneous carbon dioxide level, adjusted for baseline, as measured by a Sentec monitor.
Timepoint [1] 317255 0
10 and 20 minutes.
Secondary outcome [2] 317256 0
Minute ventilation, adjusted for baseline, calculated using a flow sensor attached to the expiratory port of the participant's mask.
Timepoint [2] 317256 0
10, 20 and 30 minutes.
Secondary outcome [3] 317257 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] 317257 0
10, 20 and 30 minutes.
Secondary outcome [4] 317259 0
Change in transcutaneous carbon dioxide greater than or equal to 4mmHg, as measured by a Sentec monitor.
Timepoint [4] 317259 0
30 minutes.
Secondary outcome [5] 317260 0
Change in transcutaneous carbon dioxide greater than or equal to 10mmHg, as measured by a Sentec monitor.
Timepoint [5] 317260 0
30 minutes.
Secondary outcome [6] 317261 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] 317261 0
10, 20 and 30 minutes.
Secondary outcome [7] 317262 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] 317262 0
10, 20 and 30 minutes.
Secondary outcome [8] 317263 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] 317263 0
10, 20 and 30 minutes.
Secondary outcome [9] 317265 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] 317265 0
10, 20 and 30 minutes.
Secondary outcome [10] 317266 0
Oxygen saturations, adjusted for baseline, as recorded on the Sentec via continuous electronic recording data download.
Timepoint [10] 317266 0
Continuously over the time course of the intervention and washout period.
Secondary outcome [11] 317267 0
Effect of baseline transcutaneous carbon dioxide, spirometry and CT findings on outcome.
Timepoint [11] 317267 0
Values at Baseline.
Secondary outcome [12] 317268 0
Heart rate, adjusted for baseline, as recorded on the Sentec.
Timepoint [12] 317268 0
10, 20 and 30 minutes.
Secondary outcome [13] 317269 0
Respiratory rate, adjusted for baseline, measured from capnography equipment.
Timepoint [13] 317269 0
10, 20 and 30 minutes.
Secondary outcome [14] 317270 0
End tidal carbon dioxide, calculated using the capnography sensor attached to expiratory port of participant's mask.
Timepoint [14] 317270 0
10, 20 and 30 minutes.
Secondary outcome [15] 317271 0
Transcutaneous carbon dioxide level as measured by Sentec and with drift correction by Sentec computer software
Timepoint [15] 317271 0
30 minutes

Eligibility
Key inclusion criteria
Cystic Fibrosis as diagnosed by a doctor, or Bronchiectasis diagnosed by a doctor and confirmed on CT scanning.
Minimum age
14 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of infection with Burkholderia
Baseline transcutaneous carbon dioxide level of greater than or equal to 60 mmHg
Diagnosis of chronic obstructive pulmonary disease
Over 10 pack year smoking history
Obesity (body mass index equal to or greater than 40)
Any other condition which, at the investigator's discretion, is believed may present a safety risk of impact feasibility of the study of 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7136 0
New Zealand
State/province [1] 7136 0

Funding & Sponsors
Funding source category [1] 291975 0
Government body
Name [1] 291975 0
Health Research Council of New Zealand
Address [1] 291975 0
Level 3- ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland, 1010
Country [1] 291975 0
New Zealand
Funding source category [2] 291976 0
Charities/Societies/Foundations
Name [2] 291976 0
Medical Research Institute of New Zealand
Address [2] 291976 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [2] 291976 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] 290641 0
Individual
Name [1] 290641 0
Richard Beasley
Address [1] 290641 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [1] 290641 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293469 0
Health and Disability Ethics Committee
Ethics committee address [1] 293469 0
20 Aitken Street
Wellington 6011
Ethics committee country [1] 293469 0
New Zealand
Date submitted for ethics approval [1] 293469 0
Approval date [1] 293469 0
23/03/2012
Ethics approval number [1] 293469 0
CEN/11/12/075

Summary
Brief summary
This study directly relates to the trial
ACTRN12612000356864. 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 bronchiectasis or cystic fibrosis and, if so, how.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60054 0
Dr Janine Pilcher
Address 60054 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 60054 0
New Zealand
Phone 60054 0
+6448050147
Fax 60054 0
Email 60054 0
janine.pilcher@mrinz.ac.nz
Contact person for public queries
Name 60055 0
Dr Janine Pilcher
Address 60055 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 60055 0
New Zealand
Phone 60055 0
+6448050147
Fax 60055 0
Email 60055 0
janine.pilcher@mrinz.ac.nz
Contact person for scientific queries
Name 60056 0
Dr Janine Pilcher
Address 60056 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 60056 0
New Zealand
Phone 60056 0
+6448050147
Fax 60056 0
Email 60056 0
janine.pilcher@mrinz.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary