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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Airvo 3 (with OptiO2) OptiO2 mode on | Experimental |
| |
| Airvo 3 (with OptiO2) OptiO2 mode off | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed loop oxygen control | Device | Nasal high flow with closed loop oxygen control |
|
| Measure | Description | 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny Han | Contact | 64 9 574 0123 | optio2trial@fphcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
Sensitivity of data, data will be used for FDA submission
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| Manual titration | Device | Nasal high flow with manual titration |
|
| Percentage of time with SpO2 below target range over period of observation |
| 24 hours |
| Central Iowa Hospital Corp - UnityPoint Health | Recruiting | Des Moines | Iowa | 50309 | United States |
|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| Temple University Hospital | Recruiting | Philadelphia | Pennsylvania | 19140 | United States |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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