COPD
Conditions
Keywords
COPD, closed loop oxygen control, hypoxemia, nasal high flow
Brief 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.
Interventions
DEVICEClosed loop oxygen control
Nasal high flow with closed loop oxygen control
DEVICEManual titration
Nasal high flow with manual titration
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Count of number of adjustments in FiO2 by clinical staff over observation period | 24 hours |
| Percentage of time with SpO2 above target range over period of observation | 24 hours |
| Percentage of time with SpO2 below target range over period of observation | 24 hours |
Countries
United States
Contacts
CONTACTJenny Han
Outcome results
None listed