Trial Review

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 registered on ANZCTR


Registration number
ACTRN12623000926639
Ethics application status
Approved
Date submitted
7/08/2023
Date registered
29/08/2023
Date last updated
5/11/2023
Date data sharing statement initially provided
29/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to investigate the effect of a new nasal mask on breathing and comfort while using non-invasive ventilation in adults with chronic respiratory failure.
Scientific title
The effect of a novel nasal mask on minute ventilation in adults with chronic respiratory failure: A pilot randomised cross-over trial.
Secondary ID [1] 309799 0
None
Universal Trial Number (UTN)
U1111-1296-2852
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic respiratory failure 330208 0
Condition category
Condition code
Respiratory 327077 327077 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study examines an investigational mask designed with soft plugs that occlude the inner nares, delivering gases with a flow path that has been modified to better refresh the anatomic dead space, with a low-profile adjustable harness system. Two variations of this novel nasal mask are compared to a standard of care oronasal mask in patients with chronic respiratory failure across continuous positive airway pressure (CPAP) and bi-level positive airway pressure at varying pressures. The study will be undertaken on a single day at a private research organisation and be supervised by doctors trained in non-invasive ventilatory (NIV) care. A doctor will provide 1:1 monitoring of ventilator settings, protocol adherence and patient adherence to therapy. Participants will trial the three masks in a randomised order. Each mask will tested across a 20-minute session of CPAP. There will be a 10-minute break between masks. The pressures during the 20-minute session of CPAP will start as 7cm H2O and be uptitrated by the doctor at 10-minutes to 12cm H2O for the remaining 10-minutes.
Intervention code [1] 326228 0
Treatment: Devices
Comparator / control treatment
This study is a 3-way cross-over study so all participants will undergo the same therapies (CPAP) using the same three masks (two versions of the investigational mask and a standard of care oronasal mask) but in a randomised order, acting as their own comparators/controls. The investigational mask is a sub-nasal mask that consists of two pillows that occlude the inner nares, delivering gases with an asymmetric flow path with a low-profile adjustable harness system. The investigational masks will be compared to a comparator mask, an oronasal mask that covers both the mouth and nose surrounded by a cushioned seal with a crown strap harness system.
Control group
Active

Outcomes
Primary outcome [1] 334942 0
To determine minute ventilation response, as measured using electrical impedance tomography, to 3 different non-invasive ventilation mask interfaces over a 10-minute standardised intervention period while receiving continuous positive airway pressure at 7cm H20 CPAP
Timepoint [1] 334942 0
End of the 10-minute CPAP intervention period adjusted for the baseline period (mean of the final 5 minutes of these periods will be used)
Secondary outcome [1] 422494 0
To determine the change in minute ventilation, as measured using electrical impedance tomography, while receiving 12cm H2O CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [1] 422494 0
End of the 20-minute CPAP intervention period adjusted for the baseline period (mean of the final 5 minutes of these periods will be used)
Secondary outcome [2] 422495 0
To determine PtCO2 response, as measured using transcutaneous CO2 earlobe sensor, while receiving 7cm H20 CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [2] 422495 0
End of the 10-minute CPAP intervention periods adjusted for baseline obtained at 0-minute period (mean of the final 60 seconds of this period will be used)
Secondary outcome [3] 422496 0
To determine respiratory rate response, as detected using ventilator device, while receiving 7cm H20 CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [3] 422496 0
End of the 10-minute CPAP intervention period adjusted for the baseline period (mean of the final 5 minutes of these periods will be used)
Secondary outcome [4] 422497 0
To determine heart rate response, as measured using earlobe sensor pulse oximetry, while receiving 7cm H20 CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [4] 422497 0
End of the 10-minute CPAP intervention period adjusted for baseline obtained at 0-minute period (mean of the final 60 seconds of this period will be used)
Secondary outcome [5] 422498 0
To determine tidal volume response, as measured using electrical impedance tomography, while receiving 7cm H20 CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [5] 422498 0
End of the 10-minute CPAP intervention period adjusted for the baseline period (mean of the final 5 minutes of these periods will be used)
Secondary outcome [6] 423361 0
To determine leak rate response, as detected using ventilator device, while receiving 7cm H20 CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [6] 423361 0
End of the 10-minute CPAP intervention period adjusted for the baseline period (mean of the final 5 minutes of these periods will be used)
Secondary outcome [7] 423362 0
To determine SpO2 response, as measured using earlobe sensor pulse oximetry, while receiving 7cm H20 CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [7] 423362 0
End of the 10-minute CPAP intervention period adjusted for baseline obtained at 0-minute period (mean of the final 60 seconds of this period will be used)
Secondary outcome [8] 423364 0
To determine physiological responses to respiratory support delivered across 3 different non-invasive ventilation mask interfaces over a 20-minute standardised intervention period using the time course of PtCO2 as measured using transcutaneous CO2 earlobe sensor
Timepoint [8] 423364 0
End of each 20-minute intervention period
Secondary outcome [9] 423365 0
To determine physiological responses to respiratory support delivered across 3 different non-invasive ventilation mask interfaces over a 20-minute standardised intervention period using the time course of SpO2 as measured using earlobe sensor pulse oximetry
Timepoint [9] 423365 0
End of each 20-minute intervention period
Secondary outcome [10] 423366 0
To determine physiological responses to respiratory support delivered across 3 different non-invasive ventilation mask interfaces over a 20-minute standardised intervention period using the time course of heart rate as measured using earlobe sensor pulse oximetry
Timepoint [10] 423366 0
End of each 20-minute intervention period
Secondary outcome [11] 423367 0
To determine physiological responses to respiratory support delivered across 3 different non-invasive ventilation mask interfaces over a 20-minute standardised intervention period using the time course of respiratory rate as detected using ventilator device
Timepoint [11] 423367 0
End of each 20-minute intervention period
Secondary outcome [12] 423368 0
To determine physiological responses to respiratory support delivered across 3 different non-invasive ventilation mask interfaces over a 20-minute standardised intervention period using the time course of minute ventilation as measured using electrical impedance tomography
Timepoint [12] 423368 0
End of each 20-minute intervention period
Secondary outcome [13] 423369 0
To determine physiological responses to respiratory support delivered across 3 different non-invasive ventilation mask interfaces over a 20-minute standardised intervention period using the time course of tidal volume as measured using electrical impedance tomography
Timepoint [13] 423369 0
End of each 20-minute intervention period
Secondary outcome [14] 423371 0
To determine physiological responses to respiratory support delivered across 3 different non-invasive ventilation mask interfaces over a 20-minute standardised intervention period using the time course of leak rate as detected using ventilator device
Timepoint [14] 423371 0
End of each 20-minute intervention period
Secondary outcome [15] 423372 0
To assess patient comfort and tolerability across difference interfaces using modified comfort Borg Dyspnoea questionnaire
Timepoint [15] 423372 0
End of each 20-minute intervention period
Secondary outcome [16] 425512 0
To determine PtCO2 response, as measured using transcutaneous CO2 earlobe sensor, while receiving 12cm H20 CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [16] 425512 0
End of the 20-minute CPAP intervention period adjusted for baseline obtained at 0-minute period (mean of the final 60 seconds of this period will be used)
Secondary outcome [17] 425513 0
To determine heart rate response, as measured using earlobe sensor pulse oximetry, while receiving 12cm H20 CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [17] 425513 0
End of the 20-minute CPAP intervention period adjusted for baseline obtained at 0-minute period (mean of the final 60 seconds of this period will be used)
Secondary outcome [18] 425525 0
To determine respiratory rate response, as detected using ventilator device, while receiving 12cm H20 CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [18] 425525 0
End of the 20-minute CPAP intervention period adjusted for baseline (mean of the final 5 minutes of this period will be used)
Secondary outcome [19] 425527 0
To determine tidal volume response, as measured using electrical impedance tomography, while receiving 12cm H20 CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [19] 425527 0
End of the 20-minute CPAP intervention period adjusted for baseline obtained at 0-minute period (mean of the final 5 minutes of this period will be used)
Secondary outcome [20] 425529 0
To determine leak rate response, as detected using ventilator device, while receiving 12cm H20 CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [20] 425529 0
End of the 20-minute CPAP intervention period adjusted for baseline obtained at 0-minute period (mean of the final 5 minutes of this period will be used)
Secondary outcome [21] 425531 0
To determine SpO2 response, as measured using earlobe sensor pulse oximetry, while receiving 12cm H20 CPAP across 3 non-invasive ventilation mask interfaces.
Timepoint [21] 425531 0
End of the 20-minute CPAP intervention period adjusted for baseline obtained at 0-minute period (mean of the final 60 seconds of this period will be used)

Eligibility
Key inclusion criteria
A doctor’s diagnosis of a chronic respiratory and/or cardiovascular disease
AND
Oxygen saturation measured by pulse oximetry (SpO2) of less than or equal to 90% while breathing room air
OR
PtcCO2 greater than or equal to 45mmHg on transcutaneous monitor at baseline measurement
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age < 18 years
• Unable to tolerate oxygen saturations on room air if on long term oxygen therapy
• Evidence of respiratory infection or colonization with multidrug resistant bacteria, Pseudomonas species, Burkholderia Cepacia or mycobacteria
• Suspected or proven infection with SARS-CoV-2 (COVID-19)
• Risk of barotrauma, as assessed by the investigator
• Nasal or facial conditions precluding use of NIV with nasal pillow or oronasal mask
• Failure of mask fitting test
• Intracranial trauma or trans-nasal neurosurgery (within 6 weeks)
• Failure of PulmoVista 500 IET electrode belt fitting (low signal quality, poor skin integrity)
• BMI >50
• Weight <50kg
• Cardiac pacemaker, an implantable cardioverter-defibrillator (ICD) or any other active implants
• Self-reported current pregnancy
• 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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised 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
Efficacy
Statistical methods / analysis
The primary outcome variable is the change in minute ventilation at 10 minutes adjusted for baseline obtained at 0-minutes across the different interfaces. Data descriptions will include mean and standard deviation (SD) and median and inter-quartile range (IQR) and minimum to maximum of the individual treatments and their differences. A mixed linear model will be used to compare the three interventions to account for the same participants being measured three times with participant treated as a random effect and order of treatment and treatment as fixed effects.
The physiological variables (PtCO2, SpO2, HR, respiratory rate, minute ventilation, tidal volume) measured at 10 minutes and 20 minutes during each intervention will be adjusted for the baseline obtained at the beginning of the intervention. These variables will be presented as mean and standard deviation (SD) and median and inter-quartile range (IQR) and minimum to maximum.
The time course of the physiological variables (PtCO2, SpO2, HR, RR, MV, TV and leak) during each intervention will be shown graphically by scatter plots of the raw and paired data with Locally Estimated Scatter Plot Smoother (LOESS) and approximate 95% confidence intervals.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/11/2023
Actual
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 25567 0
New Zealand
State/province [1] 25567 0
Wellington Region

Funding & Sponsors
Funding source category [1] 313982 0
Commercial sector/Industry
Name [1] 313982 0
Fisher & Paykel Healthcare Limited
Country [1] 313982 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare Limited
Address
15 Maurice Paykel Place, East Tamaki, Auckland 2013, NZ
Country
New Zealand
Secondary sponsor category [1] 315864 0
None
Name [1] 315864 0
Address [1] 315864 0
Country [1] 315864 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313119 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 313119 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 313119 0
New Zealand
Date submitted for ethics approval [1] 313119 0
07/08/2023
Approval date [1] 313119 0
04/09/2023
Ethics approval number [1] 313119 0
2023 FULL 16776

Summary
Brief summary
Non-invasive ventilation (NIV) is an effective treatment for a significant proportion of patients with acute respiratory failure, as well as chronic respiratory failure and sleep-disordered breathing. There are 2 main forms of NIV; continuous positive airway pressure (CPAP) and bi-level positive airway pressure (bi-level). Delivering NIV requires a ventilator device, with tubing and a mask that connects to the patients face using a soft cushion against the skin and straps around the back of the head.

This study tests a new mask designed with soft plugs that occlude the nostrils, delivering pressurised air with a flow path that has been modified to better refresh the airways of carbon dioxide, the body's waste gas, Pre-clinical testing of the investigational mask has indicated it may improve washout of the upper airways compared to a standard nasal mask and thereby could reduce the work of breathing and improve comfort for people who require NIV therapy. Two variations of the new mask will be compared to a standard of care oronasal mask, to check how effectively it helps with breathing and how comfortable it feels when it is used.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127062 0
Dr Julie Cook
Address 127062 0
7 CSB Building Wellington Hospital, Riddiford Street, Newtown, Wellington 6021
Country 127062 0
New Zealand
Phone 127062 0
+6448050147
Fax 127062 0
Email 127062 0
[email protected]
Contact person for public queries
Name 127063 0
Julie Cook
Address 127063 0
7 CSB Building Wellington Hospital, Riddiford Street, Newtown, Wellington 6021
Country 127063 0
New Zealand
Phone 127063 0
+6448050147
Fax 127063 0
Email 127063 0
[email protected]
Contact person for scientific queries
Name 127064 0
Julie Cook
Address 127064 0
7 CSB Building Wellington Hospital, Riddiford Street, Newtown, Wellington 6021
Country 127064 0
New Zealand
Phone 127064 0
+6448050147
Fax 127064 0
Email 127064 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.