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Oxygen supplementation has been proven to be effective in hypoxemic COPD patients by increasing oxygenation and reducing dyspnea. In clinical practice there are three common oxygen delivery systems used: continuous oxygen flow (CF), demand oxygen delivery with liquid oxygen (DDL) and demand oxgen delivery with portable oxygen concentrator (DDC). The CF involves considerable wastage of oxygen because oxygen is supplied during in- and exhalation. Demand oxygen delivery saves oxygen and results in a comparable oxygen saturation at rest in COPD patients. However, it is unknown, if oxygen supplementation via demand oxygen delivery is also sufficient during exercise in hypoxemic COPD patients. In addition, it has to be considered that the lower weight of demand oxygen delivery system might enable patients for higher physical activity level and mobility in daily life.
The effects of These three oxygen delivery systems shall be investigated by a randomized, controlled cross-over Trial. Every patient has to perform an Incremental Shuttle Walk Test and three Endurance Shuttle Walk Tests with three different oxygen supplementation (via CF, DDL or DDK) in randomized order.
The Principal Investigator will inform each patient about procedure, content and measurements of the study. It is obligatory that each patient participating in the study gives a written informed consent.
Following an initial incremental shuttle walk test (ISWT) in order to determine the individual maximum capacity, patients will perform three endurance shuttle walk tests (ESWT) at 85% of the maximal pace. In randomized order, patients will complete one ESWT on CF, one on DDL (liquid oxygen) and one on DDC (portable oxygen concentrator). The time between the three ESWTs will be 24 hours in order to give enough time for regeneration. All patients will use the same oxygen devices (CF: Companion 1000 (CE 0050), Chart Industries, Inc. Garfield Heights, Ohio, USA; DD [liquid oxygen]: Caire Spirit 300 (CE 0029), Chart Industries, Inc. Garfield Heights, Ohio, USA), DD [portable concentrator]: Inogen G2, California, USA) and will carry the oxygen device in a backpack. Continuous oxygen flow in liter per minute will be compared to the level of demand delivery (e.g.: 2 l/min CF will be compared to DD level 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients with delivery order 1, 2, 3 | Experimental | Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. |
|
| COPD patients with delivery order 2,3, 1 | Experimental | Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. |
|
| COPD patients with delivery order 3, 2, 1 | Experimental | Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. |
|
| COPD patients with delivery order 1, 3, 2 | Experimental | Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 continuous flow oxygen supplementation | Device | This oxygen Supplementation is used in special order |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen) | continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT |
| Measure | Description | Time Frame |
|---|---|---|
| Breathing frequency | measured by Visionox | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT |
| Inspiratory capacity | measured by Spiropalm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Kenn, Prof. Dr. | Philipps University Marburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Berchtesgadener Land | Schönau | Berchtesgardener Land | 83471 | Germany |
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| COPD patients with delivery order 2, 1, 3 | Experimental | Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. |
|
| COPD patients with delivery order 3, 1, 2 | Experimental | Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. |
|
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| 2 demand delivery liquid oxygen supplementation | Device | This oxygen Supplementation is used in special order |
|
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| 3 demand delivery oxygen supplementation via concentrator | Device | This oxygen Supplementation is used in special order |
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| at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT |
| Heart rate | continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT |
| Walking distance during ESWT | total distance walked during ESWT | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT |
| dyspnea | assessed by modified Borg scale (0 to 10) | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT |
| partial pressure of carbon dioxide | continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| 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 |
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