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The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).
Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT approximately 3l/min via nasal cannula according to a randomized cross-over design.
The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air.
The effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambient air | Experimental | Patient will perform tests at University Hospital Zurich |
|
| SOT via basal canula | Active Comparator | Supplemental Oxygen Therapy (SOT) at approximately 3l/min will be provided via nasal canula from a small oxygen concentrator while the patient performs tests at University Hospital Zurich. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6-minute walk distance (6MWD) test on ambient air | Other | 6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air | Change in 6MWD in meter between SOT via nasal cannula vs. ambient air | after 6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| SpO2 at rest and peak 6MWD with SOT vs. ambient air | Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with SOT approximately 3l /min vs. ambient air | after 6 minutes |
| Heart rate at rest and peak 6MWD with SOT vs. ambient air |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Ulrich, Prof. Dr. | University Hospital Zurich, Department of Pulmonology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zürich | Zurich | Canton of Zurich | 8091 | Switzerland |
Data will be provided upon request and based on a clear intention reviewed by an ethical review board
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Each participant is its own control
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| 6-minute walk distance test with supplemental oxygen | Other | 6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (approximately 3l/min, nasal) |
|
Change of heart rate (bpm) at rest and at peak 6MWD with SOT vs. ambient air |
| after 6 minutes |
| Borg dyspnea atrest and peak 6MWD with SOT vs. ambient air | Change of Borg dyspnea scale (CR10, 0-10 where 10 is the worst dyspnea) at rest and at peak 6MWD with SOT vs. ambient air | 6 minutes |
| Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air | Change of Borg leg fatigue scale (CR10, 0-10 where 10 is the strongest led fatugue) at rest and at peak 6MWD with SOT vs. ambient air | 6 minutes |
| Blood pressure at rest and peak 6MWD with SOT vs. ambient air | Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT vs. ambient air | after 6 minutes |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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