NCT07222410 · Fisher and Paykel Healthcare
Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the Hospital
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Closed loop oxygen control
Nasal high flow with closed loop oxygen control
DEVICE
Manual titration
Nasal high flow with manual titration
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
- Des Moines, Iowa
- New York, New York
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations