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Trial registered on ANZCTR


Registration number
ACTRN12624001478505p
Ethics application status
Submitted, not yet approved
Date submitted
27/11/2024
Date registered
18/12/2024
Date last updated
18/12/2024
Date data sharing statement initially provided
18/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Nivairo® versus Visairo® for non-invasive ventilation.
Scientific title
Peripheral oxygen saturations using Full face (Nivairo®) versus a bridge free full face (Visairo®) mask for non-invasive ventilation in intensive care unit patients: a pragmatic randomised equivalence trial.
Secondary ID [1] 313467 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Respiratory Failure 335871 0
Condition category
Condition code
Respiratory 332455 332455 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to determine whether the bridge free Visairo® mask is as effective as the full face Nivairo® mask for the delivery of NIV (Non Invasive Ventilation). To do this we have designed a pragmatic randomised equivalence trial. The Visairo® is a new NIV mask and to date there is no evidence available to demonstrate how effective this mask is in the ‘real world’ clinical context. This trial will address that gap in the evidence.
This study is a single center study at Sunshine Intensive Care Unit. A 13 bed ICU situated at Sunshine Hospital, Furlong Road, St Albans. Consecutive adult (> 18 years of age) patients admitted to the ICU who have not been mechanically ventilated during their admission, and require NIV for Type I Respiratory Failure, will be eligible for inclusion. They will be randomised to receive NIV using either the Nivairo® or Visairo® mask using permuted block randomisation with an allocation ratio of 1:1.
Clinical ICU nurses and physiotherapists will administer the intervention. Eligible patients will receive either Nivairo or Visairo for 4 continuous hours unless the fit of the mask results in excessive leak. Anecdotal evidence indicates air leaks associated with Nivairo® use are rare. If air leaks are evident with the Visairo® and alternative mask size is not rectifying this usual practice would involve switching to the Nivairo®. This switch would generally occur within the first 15 to 30 minutes of NIV implementation. Protocol deviations will be captured in the REDCap survey completed at one hour post implementation and will also be documented in the patient’s progress notes and observation chart. The investigative team is comprised of clinicians (Equipment Nurse, Nurse Unit Manager, ICU Liaison Nurse, ICU Physiotherapist, ICU Nurse Specialists) who will provide 7-day a week oversight during the trial.

Intervention code [1] 330039 0
Treatment: Devices
Comparator / control treatment
Usual Care which is the Nivairo NIV mask. Patients in the control group will receive the Nivario mask.
Control group
Active

Outcomes
Primary outcome [1] 339998 0
Peripheral oxygen saturation (SpO2).
Timepoint [1] 339998 0
We will compare the mean percentage increase in SpO2 from baseline (Time 0) between the Nivairo® (control group) and Visairo® (intervention group) at one hour (Time 1) post implementation to determine whether the Visairo® mask is equivalent to the Nivairo® mask. Time 0 will be prior to commencement of NIV
Secondary outcome [1] 442264 0
Comfort
Timepoint [1] 442264 0
Hourly for the first 4 hours from implementation of NIV.
Secondary outcome [2] 442265 0
Compliance
Timepoint [2] 442265 0
Hourly for the first four hours from implementation of NIV
Secondary outcome [3] 442266 0
Difference in mean SpO2 percentage
Timepoint [3] 442266 0
Measured hourly for 24 hours
Secondary outcome [4] 443191 0
Difference in arterial oxygenation (PaO2)
Timepoint [4] 443191 0
Reviewed for 24 hours
Secondary outcome [5] 443192 0
Difference in arterial carbon dioxide (PaCO2) levels
Timepoint [5] 443192 0
Reviewed for 24 hours.
Secondary outcome [6] 443193 0
Difference in iPAP and ePAP
Timepoint [6] 443193 0
Reviewed for 24 hours
Secondary outcome [7] 443194 0
Freedom from intubation and mechanical ventilation
Timepoint [7] 443194 0
Length of ICU stay
Secondary outcome [8] 443195 0
Incidence of device related PI
Timepoint [8] 443195 0
Review post discharge
Secondary outcome [9] 443196 0
ICU length of stay
Timepoint [9] 443196 0
Hours
Secondary outcome [10] 443197 0
Hospital Length of stay
Timepoint [10] 443197 0
Admission to Discharge in days

Eligibility
Key inclusion criteria
Consecutive adult patients admitted to the ICU that have not been mechanically ventilated during their admission and require NIV for Type 1 Respiratory Failure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years of age
Known history of dementia, claustrophobia, COPD with CO2 retention
Active signs of delirium
At risk of harming themselves of others due to mental illness or behavioral concerns
Facial injuries
Upper Airway Obstruction
Impaired Neurological function (GCS <8)
Ineffective gag
Elevated ICP
Pregnancy
Previously intubated during their current ICU admission

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)
A Research Assistant (RA) who is not a member of the investigative team will manage randomisation, the preparation of opaque envelopes for group allocation, and allocation verification.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (blocks of 2, 4 and 6), with an allocation ratio of 1:1 will be used to generate a random allocation list via computer software (Excel Spreadsheet from Biostatistician).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We have not been able to locate data that reports findings related to testing the effectiveness of bridge free NIV masks. This study has been designed to determine equivalence and with that in mind the sample size estimation and power calculation are based on determining whether the Visairo® is as effective as the Nivairo®. Most trials are designed to determine superiority and failure to show a difference does not equate to equivalence. In the context of an equivalence trial, a similar outcome is anticipated, rather than an outcome that detects inferiority or superiority . Non-inferiority trials are designed to determine whether a new treatment is no worse than standard care. This type of design requires the calculation of a non-inferiority margin that incorporates the potential for some participants to be better off and some not being better off. In this study we want to avoid increasing risk which would be necessary if we include a non-inferiority margin . As such, in conjunction with the Biostatistician on our team, we designed an equivalence trial that will require a minimum of 246 patients (123 in each group). We will aim to recruit from 246 up to 270 patients to allow for a 10% dropout rate due to agitation or clinical deterioration requiring intubation and ventilation.

When NIV is implemented, clinical observation will be focused on ensuring there is at a minimum SpO2 stability or a slight increase in SpO2. Patients who require NIV generally have a relatively low SpO2 (~90%) and the responsible clinician would be looking for a minimum 2%-point (SD 0.8%) increase in SpO2 within the first hour of NIV (90-92% SpO2). The power for this trial based on percentage increase in SpO2 was calculated in PASS 2023 (Version 23.0.2; NCSS, LLC) statistical software for 2-sided tests (a=0.05). Testing for equivalence (Visairo® has to be as effective as Nivairo®), using equivalence limits of 0.3%, a sample of 246 patients (123 per group) will yield a power of 80%, at a 5% level of significance.
Data for secondary outcomes will be exported from REDCap into Excel by the RA. The REDCap data includes corresponding Code ID and Medical Record numbers. A separate Excel file with only Code ID and Medical Record Number will be shared via safe file transfer protocols with the ICU Data Manager, who on completion of patient recruitment will extract routine data collected as a component of usual care (demographic characteristics, admission diagnosis, physiological parameters for the primary and secondary outcome measures, length of stay, incidence of PI, freedom from intubation). On completion of data extraction, screening and cleaning, Mr Kwek will delete the Medical Record numbers from this file so the data are non-identifiable but can be linked via the Code ID number to downloaded secondary outcome measures stored in Excel by the RA.
Data in Excel will be imported into IBM SPSS Statistics (Version 29.1, Chicago, Illinois) for analysis. Categorical data will be presented as frequency and proportion and continuous data as mean and standard deviation where normally distributed, or median with quartiles. Categorical variables will be analysed using chi-square test for independence or two-tailed Fisher’s exact test with appropriate degrees of freedom to test for equality of proportions. Independent samples t-tests (two-tailed) will be used to test for equality of means of continuous variables or the non-parametric equivalent Kruskal-Wallis test. The Shapiro Wilk’s test will be used to assess normality. All analyses will adopt an intention-to-treat approach. The primary outcome will be assessed using a two-sample equivalence test. Trends in secondary outcomes (SpO2, WBFS, BCS PaO2, PaCO2 and FiO2) will be explored for the first 24 hours after NIV initiation and reported descriptively.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
2/02/2026
Actual
Date of last data collection
Anticipated
6/02/2026
Actual
Sample size
Target
246
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27365 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 43458 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 317901 0
Hospital
Name [1] 317901 0
Sunshine Hospital
Country [1] 317901 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Hosptial
Address
Country
Australia
Secondary sponsor category [1] 320248 0
None
Name [1] 320248 0
Address [1] 320248 0
Country [1] 320248 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316589 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 316589 0
Ethics committee country [1] 316589 0
Australia
Date submitted for ethics approval [1] 316589 0
26/11/2024
Approval date [1] 316589 0
Ethics approval number [1] 316589 0

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

Contacts
Principal investigator
Name 138338 0
Mrs Kylie Feely
Address 138338 0
Sunshine Hospital. 176 Furlong Road. St Albans, 3012. Victoria
Country 138338 0
Australia
Phone 138338 0
+61 0383450852
Fax 138338 0
Email 138338 0
kylie.feely@wh.org.au
Contact person for public queries
Name 138339 0
Kylie Feely
Address 138339 0
Sunshine Hospital. 176 Furlong Road. St Albans, 3021 Victoria
Country 138339 0
Australia
Phone 138339 0
+61 0383450852
Fax 138339 0
Email 138339 0
kylie.feely@wh.org.au
Contact person for scientific queries
Name 138340 0
Rochelle Wynne
Address 138340 0
Sunshine Hospital. 176 Furlong Road. St Albans, 3021. Victoria
Country 138340 0
Australia
Phone 138340 0
+61 038395 8163
Fax 138340 0
Email 138340 0
Rochelle.Wynne@wh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual line-by-line data
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Researchers who provide a sound proposal
Available for what types of analyses?
IPD meta-analysis
How or where can data be obtained?
Contact Kylie Feely via email: kylie.feely@wh.org.au


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.