Not provided
Not provided
Not provided
Not provided
Slow recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Innovation Fund Denmark | INDIV |
| Naestved Hospital | OTHER |
Not provided
Not provided
Not provided
O2matic HOT is a further development of O2matic and is intended for home oxygen use with patients in need of long-term oxygen treatment (LTOT). O2matic HOT is a closed-loop system which on basis of signals from pulse oximetry titrates the oxygen flow to the patient. In this crossover trial patients are admitted for 24 hours twice. Once with usual fixed dose oxygen and once with oxygen titration by O2matic HOT.
The purpose of this study is to examine if automated oxygen control based on pulse oximetry to patients with domiciliary long-term oxygen treatment (LTOT) is better than manually controlled oxygen treatment in keeping SpO2 within intended target interval. In manually controlled oxygen treatment flow is usually kept constant for months between visits from specialist nurse, whereas in automated control the patient can titrate oxygen flow several times a day based on pulse oximetry in a closed-loop system.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual | Active Comparator | Fixed dose oxygen |
|
| O2matic | Experimental | Automated oxygen titration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| O2matic HOT | Device | Automated oxygen titration with O2matic HOT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time in intended SpO2-interval | Percentage of time with SpO2 in intended interval | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time with SpO2 below 85 % | Percentage of time with SpO2 below 85 % | 24 hours |
| Percentage of time with SpO2 below target but not below 85 % | Percentage of time with SpO2 below target but not below 85 % |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Ringbaek, PhD | Hvidovre University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Hvidovre | 2650 | Denmark | |||
| Næstved University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxygen concentrator |
| Device |
Fixed dose oxygen flow from concentrator |
|
| 24 hours |
| Percentage of time with SpO2 above target | Percentage of time with SpO2 above target | 24 hours |
| Change in PaCO2 from baseline | Change in PaCO2 from baseline to 8 hours | 8 hours |
| Change in PaCO2 from baseline | Change in PaCO2 from baseline to 24 hours | 24 hours |
| Accumulated oxygen usage | Accumulated oxygen usage in 24 hours | 24 hours |
| Adverse and serious adverse events | Adverse and serious adverse events, such as respiratory acidosis | 24 hours |
| Næstved |
| Denmark |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |