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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04947852




Registration number
NCT04947852
Ethics application status
Date submitted
24/06/2021
Date registered
1/07/2021
Date last updated
18/03/2022

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
Basic Science
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
A randomized controlled pilot study to compare the efficacy and tolerability of a two
different NIV masks on carbon dioxide in participants with stable chronic obstructive
pulmonary disease (COPD) with chronic type II respiratory failure.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04947852
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