RecruitingRecruiting
Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the Hospital
NCT07222410 · Fisher and Paykel Healthcare
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Closed Loop Oxygen Control in COPD Patients Treated With Nasal High Flow in the Hospital
About this study
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
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 target: 70 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-07
Estimated completion: 2027-11
Last updated: 2026-06-23
Interventions
Device: Closed loop oxygen controlDevice: Manual titration
Primary outcomes
- • Percentage of time with SpO2 in target range over period of observation (24 hours)
- • Percentage of time with SpO2 out of target range over period of observation (24 hours)
Sponsor
Fisher and Paykel Healthcare · industry
Contacts & investigators
ContactJenny Han · contact · optio2trial@fphcare.com · 64 9 574 0123
All locations (4)
The University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Central Iowa Hospital Corp - UnityPoint HealthRecruiting
Des Moines, Iowa, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Temple University HospitalRecruiting
Philadelphia, Pennsylvania, United States