Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000935437
Ethics application status
Approved
Date submitted
7/08/2025
Date registered
28/08/2025
Date last updated
28/08/2025
Date data sharing statement initially provided
28/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the comfort and tolerability of a new non-invasive ventilation (NIV) nasal mask in patients receiving NIV therapy
Scientific title
Feasibility of a novel NIV nasal mask in patients receiving NIV therapy in the acute setting: An exploratory study.
Secondary ID [1] 315016 0
CIA-342
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute exacerbation of chronic obstructive pulmonary disease 338579 0
Cardiogenic pulmonary oedema 338580 0
Neuromuscular disorders 338581 0
Obesity hypoventilation syndrome 338582 0
Pneumonia 338583 0
Obstructive sleep apnea 338584 0
Condition category
Condition code
Respiratory 334652 334652 0 0
Chronic obstructive pulmonary disease
Respiratory 334689 334689 0 0
Other respiratory disorders / diseases
Cardiovascular 334690 334690 0 0
Coronary heart disease
Cardiovascular 334769 334769 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a new nasal mask that can be used to deliver NIV (bi-level or continuous positive airway pressure (CPAP)) therapy for acutely-ill patients in intensive care unit (ICU) or high dependency unit (HDU). The new mask only sits inside the nostrils (that is, a nasal mask), and is designed to have improved flow dynamics.
Eligible participants who are already receiving NIV therapy through standard mask will be fitted with the new nasal mask by a treating clinician through which they will receive the therapy for a period of 30 minutes. During this period, some basic information about participants, such as the level of oxygen saturation in their blood, will be recorded. Participants will also be asked to rate their level of comfort and degree of shortness of breath using appropriate validated rating scales.
Intervention code [1] 331616 0
Treatment: Devices
Comparator / control treatment
The comparator is a standard oronasal mask (covering both the nose and mouth) commonly used to deliver NIV therapy. Eligible participants will be fitted with the standard mask by a treating clinician at the beginning of the trial through which they will receive NIV therapy for 30 minutes before switching to the new mask for another 30 minutes. At the end of the second 30 minutes, participants will be switched back to the standard mask through which they will receive NIV therapy for another 30 minutes. During both periods on standard mask, some basic information about participants, such as the level of oxygen saturation in their blood, will be recorded. Participants will also be asked to rate their level of comfort and degree of shortness of breath using appropriate validated rating scales.
Control group
Active

Outcomes
Primary outcome [1] 342345 0
Proportion of patients who were successfully treated with the new mask. Treatment success is defined as the ability of patient to tolerate and withstand the new interface without prompting removal, or the need for a clinical decision to revert patient back to the standard-of-care interface
Timepoint [1] 342345 0
After 30-minute intervention period
Secondary outcome [1] 450405 0
Patient tolerability
Timepoint [1] 450405 0
After each30-minute intervention and comparator period (assessed 3 times for each participant)
Secondary outcome [2] 450407 0
Blood oxygen saturation (SpO2)
Timepoint [2] 450407 0
The final 5 minutes of each 30-minute intervention and comparator period (assessed 3 times for each participant)
Secondary outcome [3] 451100 0
Heart rate
Timepoint [3] 451100 0
The final 5 minutes of each 30-minute intervention and comparator period (assessed 3 times for each participant)
Secondary outcome [4] 451101 0
Blood pressure
Timepoint [4] 451101 0
The final 5 minutes of each 30-minute intervention and comparator period (assessed 3 times for each participant)
Secondary outcome [5] 451102 0
Patient comfort
Timepoint [5] 451102 0
After each 30-minute intervention and comparator period (assessed 3 times by each participant)
Secondary outcome [6] 451103 0
Dyspnea (shortness of breath)
Timepoint [6] 451103 0
After each 30-minute intervention and comparator period (assessed 3 times by each participant)

Eligibility
Key inclusion criteria
Adult patients in the ICU and HDU already receiving bi-level or CPAP therapy.
Fit cognitive state with the ability to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving a nasogastric tube.
Patients prescribed a CPAP pressure setting > 15 cm H2O.
Patients prescribed a bilevel IPAP (inspiratory positive airway pressure) setting > 20 cmH2O.
Patients prescribed a FiO2 (fraction of inspired oxygen) of >0.7
Non-spontaneously breathing
Inability to provide consent
Any other condition which, at the investigators discretion, is believed may present a safety risk or impact the feasibility of the study or study results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
This is an exploratory, non-randomized, prospective feasibility study; therefore, a sample size of 10 will be used. This sample size has been used for previous pilot studies sponsored by the sponsor and represents a suitable starting sample size to determine feasibility.
Continuous variables will be summarised by mean and standard deviation (SD), median and inter-quartile range (IQR) while categorical variables will be summarised as counts and proportions, expressed as a percentage. The difference in success rates between the investigational and comparator devices will be estimated by appropriate categorical data models. The paired t-test will be used to compare the means of two continuous variables as appropriate

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/08/2025
Actual
Date of last participant enrolment
Anticipated
28/08/2026
Actual
Date of last data collection
Anticipated
28/08/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 27257 0
New Zealand
State/province [1] 27257 0
Auckland

Funding & Sponsors
Funding source category [1] 319580 0
Commercial sector/Industry
Name [1] 319580 0
Fisher & Paykel Healthcare Limited
Country [1] 319580 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare Limited
Address
Country
New Zealand
Secondary sponsor category [1] 322078 0
None
Name [1] 322078 0
Address [1] 322078 0
Country [1] 322078 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318144 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 318144 0
Ethics committee country [1] 318144 0
New Zealand
Date submitted for ethics approval [1] 318144 0
20/05/2025
Approval date [1] 318144 0
28/07/2025
Ethics approval number [1] 318144 0
2025 FULL 22419

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

Contacts
Principal investigator
Name 143254 0
Dr Tony Wiiliams
Address 143254 0
Critical Care Complex, Middlemore Hospital, 100 Hospital Road, Middlemore Hospital, Auckland 2025
Country 143254 0
New Zealand
Phone 143254 0
+64 9 276 0112
Fax 143254 0
Email 143254 0
[email protected]
Contact person for public queries
Name 143255 0
Dr James Revie
Address 143255 0
Fisher & Paykel Healthcare, 15 Maurice Paykel Place, East Tamaki, Auckland 2013
Country 143255 0
New Zealand
Phone 143255 0
+64 9 574 0100
Fax 143255 0
Email 143255 0
[email protected]
Contact person for scientific queries
Name 143256 0
Tony Wiiliams
Address 143256 0
Critical Care Complex, Middlemore Hospital, 100 Hospital Road, Middlemore Hospital, Auckland 2025
Country 143256 0
New Zealand
Phone 143256 0
+64 9 276 0112
Fax 143256 0
Email 143256 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.