Respiratory FailureNCT05059288
NIV Mask Assessment of Usability and Performance
A study testing Investigational Non Invasive Ventilation Mask in people with Respiratory Failure, run by Fisher and Paykel Healthcare.
Trial summary
Assessment of usability, perceived comfort and performance of a NIV mask in the hospital environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Investigational Non Invasive Ventilation Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 28 Oct 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted and indicated for non invasive ventilation therapy
- Assessed for capacity to consent and consent process documented
- Fits the investigation mask
- Aged 18 year or older
Who cannot join
- Contraindicated for non invasive ventilation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Usability and Performance of a Non-invasive Ventilation Mask. A Prospective Cohort.
Assessment of usability, perceived comfort and performance of a NIV mask in the hospital environment.
Read the detailed description
50 participants admitted for NIV therapy will have the investigation mask fitted. The doctors and nurses assigned to the participants care will complete a subjective evaluation on how the mask performs compared to the standard of care mask. Some therapy settings and demographics will be recorded.
- Conditions
- Respiratory Failure
- Being tested
- Investigational Non Invasive Ventilation Mask
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Non Invasive Ventilation MaskDevice
Oronasal non invasive ventilation mask
| Study group | Role | What they receive |
|---|---|---|
| Investigation Mask | Experimental | Non invasive ventilation mask Receives: Device: Investigational Non Invasive Ventilation Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived mask performance
Three point visual analogue scale on preference 1 = Worse, 2 = Same, 3 = Better
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start28 Oct 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Martynoga, Principal investigator, Waikato Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059288
- Sponsor's protocol ID
- CIA 291
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Performance of a Non-invasive Ventilation Mask. A Prospective Cohort.
- ClinicalTrials.gov ID
- NCT05059288
- Acronym / sponsor ID
- CIA 291
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of usability, perceived comfort and performance of a NIV mask in the hospital environment.
Detailed description
50 participants admitted for NIV therapy will have the investigation mask fitted. The doctors and nurses assigned to the participants care will complete a subjective evaluation on how the mask performs compared to the standard of care mask. Some therapy settings and demographics will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigation Mask | Experimental | Device: Investigational Non Invasive Ventilation MaskNon invasive ventilation mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted and indicated for non invasive ventilation therapy
- Assessed for capacity to consent and consent process documented
- Fits the investigation mask
- Aged 18 year or older
Key exclusion criteria (1 listed)
- Contraindicated for non invasive ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Non Invasive Ventilation MaskOronasal non invasive ventilation mask | Device | Investigation Mask |
Primary outcome
Perceived mask performance
Time frame: During the intervention
Three point visual analogue scale on preference 1 = Worse, 2 = Same, 3 = Better
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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Clinical Genetics Branch Eligibility Screening Survey
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Martynoga principal investigator
Waikato Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Non Invasive Ventilation Mask in people with Respiratory Failure, run by Fisher and Paykel Healthcare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica R Fogarin (095740100, jessica.fogarin@fphcare.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived mask performance (time frame: During the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.