Airvo 3 Respiratory Rate Validation Study

Fisher & Paykel Healthcare

Status: Not yet enrolling

Conditions: Healthy Volunteers; COPD

Treatments: Device: Airvo 3 with respiratory rate algorithm

Study type: Interventional

Funder types: Industry

Identifiers

NCT06329609

ClA-333

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Intervention

Experimental group

Description:

This arm will receive the study intervention

Treatment:

Device: Airvo 3 with respiratory rate algorithm