Clinical trial NCT06329609: Airvo 3 Respiratory Rate Validation 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD
Healthy Volunteers
Keywords: High flow therapy
Respiratory rate monitoring
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2024-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory rate
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Respiratory rate
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Element Boulder
state: Colorado
Study officials:
affiliation: Element Boulder
name: Monica Rabanal, MSc, BSN
role: PRINCIPAL_INVESTIGATOR
References: