NCT07222410NARecruiting
Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the Hospital
Fisher and Paykel Healthcare
Start Date
1/7/2026
Completion Date
11/1/2027
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.
Eligibility Criteria
Age Range: 22 years to No maximum
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
Interventions
DEVICE
Closed loop oxygen control
DEVICE
Manual titration
Conditions
COPD
Locations
The University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Central Iowa Hospital Corp - UnityPoint Health
Des Moines, Iowa 50309
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Temple University Hospital
Philadelphia, Pennsylvania 19140
United States