Airvo 3 Respiratory Rate Validation Study

Not Applicable

Not yet recruiting

• Conditions: COPD; Healthy Volunteers
• Interventions: Device: Airvo 3 with respiratory rate algorithm

• Registration Number: NCT06329609
• Lead Sponsor: Fisher and Paykel Healthcare

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-24
• Last Update Submitted: 2024-03-24
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26
• Study Start: 2024-04
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Airvo 3 with respiratory rate algorithm	This arm will receive the study intervention

Primary Outcome Measures

Name	Time	Method
Respiratory rate	Through study completion, an average of 6 months	Respiratory rate outputs of investigational device and a gold standard reference device (capnography)

Secondary Outcome Measures

Name	Time	Method
Respiratory rate	Through study completion, an average of 6 months	Respiratory rate outputs of investigational device and a U.S. FDA cleared pulse oximeter

Trial Locations

Locations (1)

Element Boulder; 🇺🇸 Louisville, Colorado, United States