Airvo 3 Respiratory Rate Validation Study

NCT06329609 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: ClA-333
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Healthy Volunteers

Keywords

High flow therapy; Respiratory rate monitoring

Outcome Measures

Primary Outcomes (1)

• Respiratory rate

  Respiratory rate outputs of investigational device and a gold standard reference device (capnography)

  Through study completion, an average of 6 months

Secondary Outcomes (1)

• Respiratory rate

  Through study completion, an average of 6 months

Study Arms (1)

Intervention

EXPERIMENTAL

This arm will receive the study intervention

Device: Airvo 3 with respiratory rate algorithm

Interventions

Airvo 3 with respiratory rate algorithm DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Element Boulder

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Monica Rabanal, MSc, BSN

  Element Boulder

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Revie, PhD

CONTACT

+64 9 574 0123; james.revie@fphcare.co.nz

Reuben Ayeleke, MBChB, PhD

CONTACT

reuben.ayeleke@fphcare.co.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 26, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)