COPDNCT06329609
Airvo 3 Respiratory Rate Validation Study
A study testing Airvo 3 with respiratory rate algorithm in people with COPD and Healthy Volunteers, run by Fisher and Paykel Healthcare at 1 site in United States.
Trial summary
This is a clinical performance testing to validate the accuracy of the Airvo 3 device with respiratory rate algorithm manufactured by Fisher \& Paykel Healthcare for continuous respiratory rate monitoring. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Healthy Volunteers
- What is being tested?
- Airvo 3 with respiratory rate algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2024to Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group A
- Healthy adults with no known history of respiratory disease
- Ability to provide written informed consent
- Ability to comply with study procedures and duration
- Group B
- Out-patient adults with stable COPD: Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages 2 - 4
- Ability to provide written informed consent
- Ability to comply with study procedures and duration
Who cannot join
- Pregnancy or lactation
- Inability to tolerate nasal prongs
- History of severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, electrocardiogram (ECG) electrodes, or other medical sensors
- Inability to provide consent
- Participants considered to be medically unsuitable to participate in the trial
Trial locations and contacts
1 site in 1 country.
Reuben Ayeleke, MBChB, PhD contact
United States1 site
Element Boulder
Louisville, Colorado, 80027
Monica Rabanal, MSc, BSN, monica.rabanal@element.com
Blair Holman, MS, +1 651 379 5549, Blair.Holman@element.com
About this study
Official title: Validating the Accuracy of the Airvo 3 Device for Continuous Respiratory Rate Monitoring in Healthy Adults and Chronic Obstructive Pulmonary Disease (COPD) Patients: Comparison With a Reference Benchmark
This is a clinical performance testing to validate the accuracy of the Airvo 3 device with respiratory rate algorithm manufactured by Fisher \& Paykel Healthcare for continuous respiratory rate monitoring.
Read the detailed description
The Airvo 3 device is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing patients in hospitals and sub-acute facilities. The device has recently been updated with a new feature which allows continuous monitoring of patient's respiratory rate during nasal high flow therapy. This study, therefore, aims to validate the accuracy of the respiratory rate output of the Airvo 3 device. The respiratory rate output of the Airvo 3 device will be compared to the respiratory rate output of a gold standard reference device (capnography) in healthy volunteers and COPD patients to determine the level of agreement between the respiratory rate outputs of the two devices. In addition, the respiratory rate output of the Airvo 3 device will be compared to the respiratory rate output of a United States Food and Drug Administration (U.S. FDA) cleared pulse oximeter in healthy volunteers and COPD patients to determine the level of agreement between the respiratory rate outputs of the two devices.
- Conditions
- COPD, Healthy Volunteers
- Being tested
- Airvo 3 with respiratory rate algorithm
- Keywords
- High flow therapy, Respiratory rate monitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airvo 3 with respiratory rate algorithmDevice
Airvo 3 with respiratory rate algorithm is an active humidification system used to deliver high flow respiratory gases (air and/or oxygen) and monitor respiratory rate
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm will receive the study intervention Receives: Device: Airvo 3 with respiratory rate algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate
Respiratory rate outputs of investigational device and a gold standard reference device (capnography)
Measured: Through study completion, an average of 6 months
Secondary outcomes (1)
Respiratory rate
Respiratory rate outputs of investigational device and a U.S. FDA cleared pulse oximeter
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monica Rabanal, MSc, BSN, Principal investigator, Element Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329609
- Sponsor's protocol ID
- ClA-333
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Accuracy of the Airvo 3 Device for Continuous Respiratory Rate Monitoring in Healthy Adults and Chronic Obstructive Pulmonary Disease (COPD) Patients: Comparison With a Reference Benchmark
- ClinicalTrials.gov ID
- NCT06329609
- Acronym / sponsor ID
- ClA-333
- Conditions
- COPD, Healthy Volunteers
- Keywords
- High flow therapy, Respiratory rate monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Mar 2024 (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 clinical performance testing to validate the accuracy of the Airvo 3 device with respiratory rate algorithm manufactured by Fisher \& Paykel Healthcare for continuous respiratory rate monitoring.
Detailed description
The Airvo 3 device is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing patients in hospitals and sub-acute facilities. The device has recently been updated with a new feature which allows continuous monitoring of patient's respiratory rate during nasal high flow therapy. This study, therefore, aims to validate the accuracy of the respiratory rate output of the Airvo 3 device. The respiratory rate output of the Airvo 3 device will be compared to the respiratory rate output of a gold standard reference device (capnography) in healthy volunteers and COPD patients to determine the level of agreement between the respiratory rate outputs of the two devices. In addition, the respiratory rate output of the Airvo 3 device will be compared to the respiratory rate output of a United States Food and Drug Administration (U.S. FDA) cleared pulse oximeter in healthy volunteers and COPD patients to determine the level of agreement between the respiratory rate outputs of the two devices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Airvo 3 with respiratory rate algorithmThis arm will receive the study intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Group A
- Healthy adults with no known history of respiratory disease
- Ability to provide written informed consent
- Ability to comply with study procedures and duration
- Group B
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Inability to tolerate nasal prongs
- History of severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, electrocardiogram (ECG) electrodes, or other medical sensors
- Inability to provide consent
- Participants considered to be medically unsuitable to participate in the trial
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 |
|---|---|---|
| Airvo 3 with respiratory rate algorithmAirvo 3 with respiratory rate algorithm is an active humidification system used to deliver high flow respiratory gases (air and/or oxygen) and monitor respiratory rate | Device | Intervention |
Primary outcome
Respiratory rate
Time frame: Through study completion, an average of 6 months
Respiratory rate outputs of investigational device and a gold standard reference device (capnography)
1 secondary outcome
Respiratory rate
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Reuben Ayeleke, MBChB, PhD contact
Monica Rabanal, MSc, BSN principal investigator
Element Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airvo 3 with respiratory rate algorithm in people with COPD and Healthy Volunteers, run by Fisher and Paykel Healthcare at 1 site in United States.
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 8 inclusion and 5 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 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 James Revie, PhD (+64 9 574 0123 ext. 7733, james.revie@fphcare.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate (time frame: Through study completion, an average of 6 months). 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 26 Mar 2024; AzTrials last refreshed its copy on 29 Oct 2026.