COPD, Healthy Volunteers
Conditions
Keywords
High flow therapy, Respiratory rate monitoring
Brief 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.
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.
Interventions
DEVICEAirvo 3 with respiratory rate algorithm
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
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate | Through study completion, an average of 6 months | Respiratory rate outputs of investigational device and a gold standard reference device (capnography) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate | Through study completion, an average of 6 months | Respiratory rate outputs of investigational device and a U.S. FDA cleared pulse oximeter |
Countries
United States
Contacts
Primary ContactJames Revie, PhD
Backup ContactReuben Ayeleke, MBChB, PhD
Outcome results
None listed