Closed-loop oxygen control with nasal high flow for hospitalized COPD patients
Closed Loop Oxygen Control in COPD Patients Treated With Nasal High Flow in the Hospital
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Fisher and Paykel Healthcare Industry-sponsored |
| Locations | 3 sites (Des Moines, Iowa and 2 other locations) |
| Trial ID | NCT07222410 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Des Moines, Iowa and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.