Respiratory Failure Requiring Non Invasive VentilationNCT06939920
NIV With Airway Washout for Dual Limb Ventilation: Improvement in Minute Ventilation
A study testing Non-invasive ventilation mask with airway washout and non-invasive ventilation in people with Respiratory Failure Requiring Non Invasive Ventilation, run by Fisher and Paykel Healthcare.
Trial summary
This is a prospective, non-randomized, non-blinded, crossover feasibility investigation to assess the safety, usability, and efficacy of the investigational mask in the hospital environment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Respiratory Failure Requiring Non Invasive Ventilation
- What is being tested?
- Non-invasive ventilation mask with airway washout and non-invasive ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults admitted to the ICU prescribed NIV and stable
- Able to receive therapy on a sub-nasal (under-the-nose) mask
- Are 18 years old or older
Who cannot join
- Contraindicated for NIV
- NIV is likely to fail and/or intubation be required, at the medical staff's discretion
- Bilevel pressure of ≥ 30 cmH2O required
- Do not fit the investigational mask or the standard mask
- Pregnancy (tested under standard care)
- Unable to tolerate NIV for the duration of the investigation
- Agitated
- Unable to understand the consent process
About this study
This is a prospective, non-randomized, non-blinded, crossover feasibility investigation to assess the safety, usability, and efficacy of the investigational mask in the hospital environment. Eligible patients that are stable in NIV and able to give informed consent will be approached and if they consent the patient will be included in the study. If potential participants decline, normal hospital care will be continued. The enrolled participant will receive NIV on the commercially available Visairo mask for one hour during which their ventilatory parameters will be logged. Then the participant will be switched to the investigational mask for another hour. The ventilator data will be collected for these two hours. At the end of the intervention the participant will be reverted to their original mask. The medical staff will be asked to fill out the case report form pertaining to the function and usability of the investigational mask compared to the conventional mask.
Read the detailed description
In an acute setting, Non-invasive ventilation (NIV) is a method of delivering respiratory support without using an endotracheal tube. It's a first-line treatment for specific conditions like COPD exacerbations and acute cardiogenic pulmonary edema. NIV aims to improve gas exchange, reduce work of breathing, avoid intubation, and reduce complications.
For patients with COPD exacerbations and acute cardiogenic pulmonary edema NIV is a first line therapy. NIV is also considered for other conditions like acute respiratory failure due to asthma exacerbation and in immunocompromised individuals with acute respiratory insufficiency. Additionally, it can be used in post-operative respiratory failure, for difficult weaning, and to prevent post-extubation failure.
NIV has been shown to result in overall better outcomes than mechanical ventilation with reduced mortality and morbidity, fewer ICU acquired infections improved lung function and shorter ICU stays. The severity of the respiratory insufficiency influences the likelihood of successful NIV. One factor associated with respiratory sufficiency is respiratory dead space. This is the volume in the respiratory apparatus that does not partake in gas exchange and in the ventilated patient includes the volume in the equipment, the conductive airways and pathological respiratory tissue. A high dead-space fraction early in the course of the illness is association with increased risk of death.9 Particularly in patients that have a small tidal volume and high respiratory rate, or patients with an increased physiological dead space due to lung disease, a change in instrumental dead space can have a large impact on alveolar minute ventilation. Improved alveolar ventilation can improve CO2 elimination and help to reduce respiratory acidosis as well as improve oxygen delivery.10, 11 This can consequently reduce the respiratory effort required by the patient. 12 If the physician instead chooses to keep arterial CO2 concentration (PaCO2) constant, a reduction of instrumental dead space will allow a reduction of tidal volume, plateau pressure, driving pressure, or a reduction of the respiratory rate and thus a reduction in work of breathing.
NIV with washout improves ventilation compared to conventional NIV by reducing expired air in each breath. This may result in faster normalization of ventilatory gasses and a reduced work of breathing, the patient may improve more rapidly as alveolar ventilation is improved. Or, allow for a reduction in pressure for similar ventilatory benefits, potentially improving NIV tolerance and therapy adherence. In stable COPD patients, NIV with Airway Washout resulted in a significant reduction in minute ventilation compared to conventional NIV. This was approximately 19% lower with OptiNIV compared to conventional NIV.15 In this study minute ventilation will be calculated from the RR and Vt retrieved from the ventilator to asses improvement in ventilation over the study period, this feasibility pilot aims to establish efficacy of airway washout and whether the increased leak required for dead space flushing does not impact safety, usability and performance. When airway washout for dual limb ventilators becomes widely available it may improve NIV therapy efficacy by improving ventilation or reducing the pressure needed for a similar level of ventilatory support.
- Being tested
- Non-invasive ventilation mask with airway washout, non-invasive ventilation
- Keywords
- Non-invasive ventilation, OptiNIV, Airway washout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilation mask with airway washoutOther
Non-invasive ventilation mask with airway washout for dual limb ventilators
non-invasive ventilationOther
standard state of the art non-invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| Visairo | Active comparator | Visairo is a commercially available sub nasal oronasal mask that has a similar design as the interventional OptiNIV Dual Mask Receives: Other: non-invasive ventilation |
| OptiNIV Dual | Experimental | Like the commercially available OptiNIV mask, this mask provides NIV with airway washout but now for dual limb ventilators. Receives: Other: Non-invasive ventilation mask with airway washout |
What is being measured
The primary outcome is the main question the study is designed to answer.
minute ventilation
To establish that the performance of the investigational mask is on par or better than a conventional NIV. Comparing the Visairo and the investigational masks for a reduction in minute ventilation over the 1 hour study period. We anticipate a reduction in minute ventilation that is 2L/min less than in the comparator mask. This will be established with a paired T test over the first 5 and last 5 min of data extracted from the ventilator.
Measured: The first 5 minutes on each mask will be compared to the last 5 minutes on the same mask and the differences compared by paired T-test.
Secondary outcomes (5)
Ventilator data (pressure)
Data will be downloaded from the ventilator after the trial is concluded. This will include pressure flow and leak data as well as alarms and settings. This data will be compared between arms to see if the ventilators behave statistically different between arms and if so on what parameters. Pressure data will be compared via paired T-test between arms.
Measured: Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.
Ventilator data (flow)
Data will be downloaded from the ventilator after the trial is concluded. This will include pressure flow and leak data as well as alarms and settings. This data will be compared between arms to see if the ventilators behave statistically different between arms and if so on what parameters. Flow data will be compared via paired T-test between arms.
Measured: Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.
user feedback
To establish that the safety, usability and performance of the investigational mask is on par with a conventional NIV, according to the attending nurse/healthcare provider. The attending nurse/healthcare provider will complete a questionnaire, comparing the Visairo and the OptiNIV dual masks. Whether the masks performed similarly, ease of therapy establishment, if any asynchrony was noticed, if in their opinion the participants were equally comfortable in both masks. This is qualitative data, each of the 5 questions will be given a score from 1-5 for a maximum of 25. a Score of 8-17 being neutral below will favor the conventional mask above will favor the investigational mask.
Measured: once both arms are completed, right after the 2 hours on NIV
Ventilator data (leak)
Data will be downloaded from the ventilator after the trial is concluded. This will include pressure flow and leak data as well as alarms and settings. This data will be compared between arms to see if the ventilators behave statistically different between arms and if so on what parameters. Leak data will be compared via paired T-test between arms.
Measured: Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.
Ventilator data (alarms)
Data will be downloaded from the ventilator after the trial is concluded. This will include pressure flow and leak data as well as alarms and settings. This data will be compared between arms to see if the ventilators behave statistically different between arms and if so on what parameters. Alarm data will be compared via paired T-test between arms.
Measured: Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Failure Requiring Non Invasive VentilationStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- prospective, non-randomized, non-blinded, crossover pilot investigation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939920
- Sponsor's protocol ID
- Fisher and Paykel Healthcare
- Status last verified
- May 2025
- First submitted
- 31 Mar 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIV With Airway Washout for Dual Limb Ventilation: Improvement in Minute Ventilation
- ClinicalTrials.gov ID
- NCT06939920
- Acronym / sponsor ID
- Fisher and Paykel Healthcare
- Keywords
- Non-invasive ventilation, OptiNIV, Airway washout
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 23 Apr 2025 (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.
This is a prospective, non-randomized, non-blinded, crossover feasibility investigation to assess the safety, usability, and efficacy of the investigational mask in the hospital environment. Eligible patients that are stable in NIV and able to give informed consent will be approached and if they consent the patient will be included in the study. If potential participants decline, normal hospital care will be continued. The enrolled participant will receive NIV on the commercially available Visairo mask for one hour during which their ventilatory parameters will be logged. Then the participant will be switched to the investigational mask for another hour. The ventilator data will be collected for these two hours. At the end of the intervention the participant will be reverted to their original mask. The medical staff will be asked to fill out the case report form pertaining to the function and usability of the investigational mask compared to the conventional mask.
Detailed description
In an acute setting, Non-invasive ventilation (NIV) is a method of delivering respiratory support without using an endotracheal tube. It's a first-line treatment for specific conditions like COPD exacerbations and acute cardiogenic pulmonary edema. NIV aims to improve gas exchange, reduce work of breathing, avoid intubation, and reduce complications.
For patients with COPD exacerbations and acute cardiogenic pulmonary edema NIV is a first line therapy. NIV is also considered for other conditions like acute respiratory failure due to asthma exacerbation and in immunocompromised individuals with acute respiratory insufficiency. Additionally, it can be used in post-operative respiratory failure, for difficult weaning, and to prevent post-extubation failure.
NIV has been shown to result in overall better outcomes than mechanical ventilation with reduced mortality and morbidity, fewer ICU acquired infections improved lung function and shorter ICU stays. The severity of the respiratory insufficiency influences the likelihood of successful NIV. One factor associated with respiratory sufficiency is respiratory dead space. This is the volume in the respiratory apparatus that does not partake in gas exchange and in the ventilated patient includes the volume in the equipment, the conductive airways and pathological respiratory tissue. A high dead-space fraction early in the course of the illness is association with increased risk of death.9 Particularly in patients that have a small tidal volume and high respiratory rate, or patients with an increased physiological dead space due to lung disease, a change in instrumental dead space can have a large impact on alveolar minute ventilation. Improved alveolar ventilation can improve CO2 elimination and help to reduce respiratory acidosis as well as improve oxygen delivery.10, 11 This can consequently reduce the respiratory effort required by the patient. 12 If the physician instead chooses to keep arterial CO2 concentration (PaCO2) constant, a reduction of instrumental dead space will allow a reduction of tidal volume, plateau pressure, driving pressure, or a reduction of the respiratory rate and thus a reduction in work of breathing.
NIV with washout improves ventilation compared to conventional NIV by reducing expired air in each breath. This may result in faster normalization of ventilatory gasses and a reduced work of breathing, the patient may improve more rapidly as alveolar ventilation is improved. Or, allow for a reduction in pressure for similar ventilatory benefits, potentially improving NIV tolerance and therapy adherence. In stable COPD patients, NIV with Airway Washout resulted in a significant reduction in minute ventilation compared to conventional NIV. This was approximately 19% lower with OptiNIV compared to conventional NIV.15 In this study minute ventilation will be calculated from the RR and Vt retrieved from the ventilator to asses improvement in ventilation over the study period, this feasibility pilot aims to establish efficacy of airway washout and whether the increased leak required for dead space flushing does not impact safety, usability and performance. When airway washout for dual limb ventilators becomes widely available it may improve NIV therapy efficacy by improving ventilation or reducing the pressure needed for a similar level of ventilatory support.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, non-randomized, non-blinded, crossover pilot investigation
| Arm | Type | Receives |
|---|---|---|
| Visairo | Active comparator | Other: non-invasive ventilationVisairo is a commercially available sub nasal oronasal mask that has a similar design as the interventional OptiNIV Dual Mask |
| OptiNIV Dual | Experimental | Other: Non-invasive ventilation mask with airway washoutLike the commercially available OptiNIV mask, this mask provides NIV with airway washout but now for dual limb ventilators. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults admitted to the ICU prescribed NIV and stable
- Able to receive therapy on a sub-nasal (under-the-nose) mask
- Are 18 years old or older
Key exclusion criteria (8 listed)
- Contraindicated for NIV
- NIV is likely to fail and/or intubation be required, at the medical staff's discretion
- Bilevel pressure of ≥ 30 cmH2O required
- Do not fit the investigational mask or the standard mask
- Pregnancy (tested under standard care)
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 |
|---|---|---|
| Non-invasive ventilation mask with airway washoutNon-invasive ventilation mask with airway washout for dual limb ventilators | Other | OptiNIV Dual |
| non-invasive ventilationstandard state of the art non-invasive ventilation | Other | Visairo |
Primary outcome
minute ventilation
Time frame: The first 5 minutes on each mask will be compared to the last 5 minutes on the same mask and the differences compared by paired T-test.
To establish that the performance of the investigational mask is on par or better than a conventional NIV. Comparing the Visairo and the investigational masks for a reduction in minute ventilation over the 1 hour study period. We anticipate a reduction in minute ventilation that is 2L/min less than in the comparator mask. This will be established with a paired T test over the first 5 and last 5 min of data extracted from the ventilator.
5 secondary outcomes
Ventilator data (pressure)
Time frame: Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.
Ventilator data (flow)
Time frame: Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.
user feedback
Time frame: once both arms are completed, right after the 2 hours on NIV
Ventilator data (leak)
Time frame: Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.
Ventilator data (alarms)
Time frame: Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive ventilation mask with airway washout and non-invasive ventilation in people with Respiratory Failure Requiring Non Invasive Ventilation, 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 22 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
minute ventilation (time frame: The first 5 minutes on each mask will be compared to the last 5 minutes on the same mask and the differences compared by paired T-test.). 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 22 May 2025.