Airvo 3 Respiratory Rate Validation Study

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06329609
• Other study ID #: ClA-333
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Fisher and Paykel Healthcare
• Contact: James Revie, PhD
• Phone: +64 9 574 0123
• Email: james.revie[@]fphcare.co.nz
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Healthy Volunteers

Intervention

Device:
• Airvo 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

Locations

Country	Name	City	State
United States	Element Boulder	Louisville	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory rate	Respiratory rate outputs of investigational device and a gold standard reference device (capnography)	Through study completion, an average of 6 months
Secondary	Respiratory rate	Respiratory rate outputs of investigational device and a U.S. FDA cleared pulse oximeter	Through study completion, an average of 6 months