Recruiting

Airvo 3

Sponsor:

Fisher and Paykel Healthcare

Code:

NCT07222410

Conditions

COPD

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Closed loop oxygen control

Manual titration

Study Details

Brief summary:

The trial aims to evaluate whether the Airvo 3 device in OptiO2 mode can maintain patients' SpO2 levels within the target range better than manual oxygen titration in hospitalized COPD patients with hypoxemia/respiratory distress.

Conditions

COPD

Study ID

NCT07222410

Start date

Jan 7, 2026

Status verified date

Oct, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Has cognitive ability to provide informed consent
  • Aged 22 years or older
  • Hospitalized with hypoxemia/respiratory distress
  • Diagnosis of COPD
  • Candidate for/currently prescribed nasal high flow (flow rate of at least 25 L/min) with supplemental oxygen, as assessed by the investigator
  • Expected duration of oxygen and nasal high flow therapy >24 hours (not necessarily continuous)

Exclusion Criteria:

  • Receiving Non Invasive Ventilation (NIV) or indicated for NIV as per European Respiratory Society /American Thoracic Society guidelines
  • Hemodynamic instability (systolic blood pressure <90mmHg or requirement for vasopressor or inotropic support)
  • Patient receiving end of life care
  • Nasal or facial conditions precluding use of nasal high flow
  • Pregnancy or breastfeeding
  • Cognitive impairment or impaired consciousness precluding informed consent
  • Unsuitable for adhesive finger pulse oximetry, as assessed by the investigator
  • Any other condition which, at the investigator's discretion, is believed to present a safety risk to the patient if included
  • The presence of any active comorbidities that affect the patient's condition importantly in the next 30 days, as assessed by the investigator
  • Has already participated in this clinical trial

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Airvo 3 (with OptiO2) OptiO2 mode on

active comparator: Airvo 3 (with OptiO2) OptiO2 mode off

Interventions

Closed loop oxygen control

Nasal high flow with closed loop oxygen control

Manual titration

Nasal high flow with manual titration

Primary outcome measure

  • Percentage of time with SpO2 in target range over period of observation [ Time Frame: 24 hours ]
  • Percentage of time with SpO2 out of target range over period of observation [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Jenny Han

64 9 574 0123optio2trial@fphcare.com

Locations

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Raymond C Wade

205-934-2490rcwade@uab.edu

Central Iowa Hospital Corp - UnityPoint Health

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Matthew Trump

515-205-4013mtrump@iowaclinic.com

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Kathryn Dubowski

212-420-2377Kathryn.Dubowski@mountsinai.org

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Gerard Criner

215-707-8113Gerard.Criner@tuhs.temple.edu

More Information

Sponsor

Fisher and Paykel Healthcare

Last update posted

Jun 23, 2026

Last verified

Oct, 2025

Keywords

  • COPD
  • closed loop oxygen control
  • hypoxemia
  • nasal high flow

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fisher and Paykel Healthcare on 2026-06-23.