Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04947852




Registration number
NCT04947852
Ethics application status
Date submitted
24/06/2021
Date registered
1/07/2021

Titles & IDs
Public title
Efficacy of NIV Masks in COPD
Scientific title
Efficacy of NIV Masks in COPD Patients With Chronic Respiratory Failure: A Randomized Controlled Cross Over Pilot
Secondary ID [1] 0 0
CIA293
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Investigation Mask
Treatment: Devices - Comparator Mask

Experimental: Investigation Mask - Bi Level CPAP Mask

Active comparator: Comparator Mask - Bi Level CPAP Mask


Treatment: Devices: Investigation Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff

Treatment: Devices: Comparator Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Transcutaneous Carbon Dioxide
Timepoint [1] 0 0
60 minutes
Secondary outcome [1] 0 0
Oxygen Saturation
Timepoint [1] 0 0
60 minutes
Secondary outcome [2] 0 0
Minute Ventilation
Timepoint [2] 0 0
60 minutes
Secondary outcome [3] 0 0
Heart Rate
Timepoint [3] 0 0
60 minutes
Secondary outcome [4] 0 0
Respiratory Rate
Timepoint [4] 0 0
60 minutes
Secondary outcome [5] 0 0
Borg Dyspnoea Score
Timepoint [5] 0 0
60 Minutes

Eligibility
Key inclusion criteria
* A doctor's diagnosis of COPD
* PtCO2 =45mmHg on transcutaneous monitor at baseline measure
* Oxygen saturation measured by pulse oximetry (SpO2) =85%
* Fits the study mask
* Can tolerate the therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* FEV1/FVC =70%
* Body mass index >35
* Hypercapnia considered to be primarily due to Obesity Hypoventilation syndrome and/or Obstructive Sleep Apnea
* Any condition which makes NIV contra-indicated as per BTS guidelines based on clinical judgement

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not 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
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/03/2022
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Alex Semprini
Address 0 0
Medical Research Institute of New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no plan to make IPD available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04947852