Closed-loop oxygen control with nasal high flow for hospitalized COPD patients
Official title: Closed Loop Oxygen Control in COPD Patients Treated With Nasal High Flow in the Hospital
Run by Fisher and Paykel Healthcare · NCT07222410 · Data updated 2026-11-12
This trial will test whether the Airvo 3 device in OptiO2 mode can keep blood oxygen (SpO2) within the target range better than manual oxygen adjustments for hospitalized COPD patients on nasal high flow.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Fisher and Paykel Healthcare Industry-sponsored |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Status | Recruiting |
| Started | January 7, 2026 |
| Main results expected | November 2027 |
| Study ends | November 2027 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT07222410 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 22 or older hospitalized with COPD and hypoxemic respiratory distress who are candidates for nasal high flow (≥25 L/min), expected to need oxygen >24 hours, and able to give informed consent.
✕Probably not a fit
Patients who need noninvasive ventilation, have hemodynamic instability, are receiving end-of-life care, have nasal/facial contraindications, are pregnant/breastfeeding, or cannot use finger pulse oximetry are excluded and unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial compares the Airvo 3 device's OptiO2 closed-loop oxygen control to standard manual oxygen titration in hospitalized patients with COPD and hypoxemic respiratory distress. Eligible patients are those prescribed or considered candidates for nasal high flow therapy at flows ≥25 L/min with supplemental oxygen and an expected need for therapy longer than 24 hours. Participants will be managed with either the closed-loop system or manual titration while continuous SpO2 is monitored to measure time spent in the prespecified target range and episodes of hypo- or hyperoxemia. Patients requiring noninvasive ventilation, hemodynamic support, or with contraindications to nasal high flow or pulse oximetry are excluded.
Why it matters
Potential benefit: If successful, the device could reduce time spent with dangerously low or high oxygen levels and make oxygen management easier for hospitalized COPD patients on nasal high flow.
How similar studies have gone: Closed-loop oxygen systems have improved time-in-range in other settings (ICU, neonatal, and some COVID-era studies), but data specifically for hospitalized COPD patients on nasal high flow remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
The University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting -
Central Iowa Hospital Corp - UnityPoint Health
Des Moines, Iowa, United States Recruiting -
Icahn School of Medicine at Mount Sinai
New York, New York, United States Recruiting -
Temple University Hospital
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Study coordinator: Jenny Han
- Email: optio2trial@fphcare.com
- Phone: 64 9 574 0123
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.