Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the Hospital
Recruiting · NCT07222410 · Interventional (participants receive a specific treatment) · Lead sponsor: Fisher and Paykel Healthcare
View the official record on ClinicalTrials.gov →Interventions studied
Closed loop oxygen controlManual titration
What this trial 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.
Who can take part
Age range
22 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
4 locations listed across 4 US states.
- The University of Alabama at Birmingham - Birmingham, Alabama, United States
- Central Iowa Hospital Corp - UnityPoint Health - Des Moines, Iowa, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Temple University Hospital - Philadelphia, Pennsylvania, United States