Noninvasive VentilationNCT05964244
Impact of Noninvasive With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure
A study testing Vela Investigational Mask and Nivairo Standard Mask in people with Noninvasive Ventilation, run by Fisher and Paykel Healthcare.
Trial summary
This study will determine if NIV using the Vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in acute patients with hypercapnic respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Noninvasive Ventilation
- What is being tested?
- Vela Investigational Mask and Nivairo Standard Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to May 2024
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have type II acute respiratory failure (ARF) and have been prescribed NIV
- Arterial blood gas (ABG) Partial pressure of arterial carbon dioxide greater or equal to 6.0 kilopascals (45 millimeters of mercury)
- Arterial blood gas acidity greater or equal to 7.35 prior to bilevel commencement
- On NIV for 24 hours or less
- Negative Covid-19 test
- Are 18 years or older
Who cannot join
- Contraindicated for NIV
- On NIV in Emergency Department/ ward for more than 24 hours, within the last 48 hours
- NIV is likely to fail and/or intubation be required, at the doctor's discretion
- CPAP or bilevel pressure of 25 centimeters of water or more is required
- Unable to tolerate NIV for the duration of the investigation
- Do not fit the investigational mask or the standard mask
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- Pregnancy (tested under standard care)
- Agitated
- Unable to understand the consent process
About this study
Official title: Evaluate the Impact of Noninvasive (NIV) With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure. A Prospective, Randomized Cross Over Pilot Investigation.
This study will determine if NIV using the Vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in acute patients with hypercapnic respiratory failure. Patients admitted to hospital with acute respiratory failure (ARF) will be assessed for hypercapnic ARF by normal hospital protocols. Patients requiring noninvasive ventilation (NIV) will be set up on NIV as prescribed per standard of care. Enrollment onto the investigation will occur after the patient has been allowed to stabilize on NIV . Patients that meet the inclusion/exclusion criteria will be approached for consent. Investigation participants will receive two masks in random order;
- NIV for one hour with the investigational mask (Vela)
- NIV for one hour with the standard mask (Nivairo).
Participants will have their physiological respiratory parameters recorded.
Read the detailed description
This is a simple study. Patients who are already on noninvasive ventilation (NIV) for acute respiratory failure will be approached for the study within the first 24 hours on NIV therapy.
The study will be conducted as described above. After the study patients will be able to choose which mask they continue their NIV on. They will continue NIV as part of their normal hospital care.
- Conditions
- Noninvasive Ventilation
- Being tested
- Vela Investigational Mask, Nivairo Standard Mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vela Investigational MaskDevice
Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.
Nivairo Standard MaskDevice
Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive ventilation (CPAP or bilevel) with the Vela investigational mask for 1 hour | Experimental | Pressure settings for noninvasive ventilation to be set as required to provide optimal respiratory support for each patient. Not to be changed during the 2 hours of the study. Receives: Device: Vela Investigational Mask |
| Noninvasive ventilation (CPAP or bilevel) with the standard mask (Nivairo) for 1 hour | Active comparator | Pressure settings for noninvasive ventilation to be set as required to provide optimal respiratory support for each patient. Not to be changed during the 2 hours of the study. Receives: Device: Nivairo Standard Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in respiratory rate
The change in patient's respiratory rate over the 1 hour of the study arm
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study startNov 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover study where each participant receives NIV on the Vela investigational mask and the Nivairo standard mask for one hour each in random order.
- 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
- NCT05964244
- Sponsor's protocol ID
- FisherPaykel
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Impact of Noninvasive (NIV) With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure. A Prospective, Randomized Cross Over Pilot Investigation.
- ClinicalTrials.gov ID
- NCT05964244
- Acronym / sponsor ID
- FisherPaykel
- Conditions
- Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Nov 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 27 Jul 2023 (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 study will determine if NIV using the Vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in acute patients with hypercapnic respiratory failure. Patients admitted to hospital with acute respiratory failure (ARF) will be assessed for hypercapnic ARF by normal hospital protocols. Patients requiring noninvasive ventilation (NIV) will be set up on NIV as prescribed per standard of care. Enrollment onto the investigation will occur after the patient has been allowed to stabilize on NIV . Patients that meet the inclusion/exclusion criteria will be approached for consent. Investigation participants will receive two masks in random order;
- NIV for one hour with the investigational mask (Vela)
- NIV for one hour with the standard mask (Nivairo).
Participants will have their physiological respiratory parameters recorded.
Detailed description
This is a simple study. Patients who are already on noninvasive ventilation (NIV) for acute respiratory failure will be approached for the study within the first 24 hours on NIV therapy.
The study will be conducted as described above. After the study patients will be able to choose which mask they continue their NIV on. They will continue NIV as part of their normal hospital care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover study where each participant receives NIV on the Vela investigational mask and the Nivairo standard mask for one hour each in random order.
| Arm | Type | Receives |
|---|---|---|
| Noninvasive ventilation (CPAP or bilevel) with the Vela investigational mask for 1 hour | Experimental | Device: Vela Investigational MaskPressure settings for noninvasive ventilation to be set as required to provide optimal respiratory support for each patient. Not to be changed during the 2 hours of the study. |
| Noninvasive ventilation (CPAP or bilevel) with the standard mask (Nivairo) for 1 hour | Active comparator | Device: Nivairo Standard MaskPressure settings for noninvasive ventilation to be set as required to provide optimal respiratory support for each patient. Not to be changed during the 2 hours of the study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have type II acute respiratory failure (ARF) and have been prescribed NIV
- Arterial blood gas (ABG) Partial pressure of arterial carbon dioxide greater or equal to 6.0 kilopascals (45 millimeters of mercury)
- Arterial blood gas acidity greater or equal to 7.35 prior to bilevel commencement
- On NIV for 24 hours or less
- Negative Covid-19 test
Key exclusion criteria (9 listed)
- Contraindicated for NIV
- On NIV in Emergency Department/ ward for more than 24 hours, within the last 48 hours
- NIV is likely to fail and/or intubation be required, at the doctor's discretion
- CPAP or bilevel pressure of 25 centimeters of water or more is required
- Unable to tolerate NIV for the duration of the investigation
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 |
|---|---|---|
| Vela Investigational MaskWear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy. | Device | Noninvasive ventilation (CPAP or bilevel) with the Vela investigational mask for 1 hour |
| Nivairo Standard MaskWear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy. | Device | Noninvasive ventilation (CPAP or bilevel) with the standard mask (Nivairo) for 1 hour |
Primary outcome
Change in respiratory rate
Time frame: 1 hour
The change in patient's respiratory rate over the 1 hour of the study arm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
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Validation of the Turkish Version of the S3-NIV Questionnaire
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Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
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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.
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 Vela Investigational Mask and Nivairo Standard Mask in people with Noninvasive 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 6 inclusion and 9 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 27 Jul 2023. 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?
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?
Change in respiratory rate (time frame: 1 hour). 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 27 Jul 2023.