Airvo 3 Respiratory Rate Validation Study | NCT06329609

Studies
Airvo 3 Respiratory Rate Validation Study

NCT06329609

Sponsor

Fisher and Paykel Healthcare

Status

Unknown status

Last Update Posted

Mar 26, 2024Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

COPD
Healthy Volunteers

Interventions

Airvo 3 with respiratory rate algorithm

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2024Estimated

Primary Completion Date

Oct 2024Estimated

Completion Date

Oct 2024Estimated

First Submitted Date

Mar 14, 2024

First Submission Date that Met QC Criteria

Mar 24, 2024

First Posted Date

Mar 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2024

Last Update Posted Date

Mar 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	This arm will receive the study intervention	Device: Airvo 3 with respiratory rate algorithm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
James Revie, PhD	Contact	+64 9 574 0123	7733	james.revie@fphcare.co.nz
Reuben Ayeleke, MBChB, PhD	Contact			reuben.ayeleke@fphcare.co.nz

Overall Officials

Name	Affiliation	Role
Monica Rabanal, MSc, BSN	Element Boulder	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Element Boulder		Louisville	Colorado	80027	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

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Browse Branches

Not provided