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To study the effect of SOT in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on pulmonary artery pressure (PAP) and other hemodynamics by echocardiography and in relation to blood gases at 2840m with and without SOT.
Patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA >2500 (PVDHA) will have echocardiografy to assess PAP, cardiac output and other hemodynamics and arterial blood gas to assess SaO2, PaO2 and PaCO2 near their living altitude in Quito at 2840m whilst breathing ambient air or SOT at 10l/min flow via a face mask with reservoir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (ambient hypoxic air at 2840m) | Sham Comparator | Ambient hypoxic air at 2840 m will be applied via a facial mask with reservoir |
|
| SOT (high flow supplemental oxygen therapy) | Experimental | SOT (supplemental oxygen therapy) at a flow of 10 l/min will be applied via a facial mask with reservoir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplemental oxygen therapy | Other | Mobile oxygen via pressurized bottle or mobile oxygen concentrator will be applied |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary Artery Pressure with SOT vs. placebo | Change in PAP in mmHg assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiac Output with SOT vs. placebo | Change in cardiac output (l/min) assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen |
| Change in right to left heart diameter ratio with SOT vs. placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Ulrich, Prof. Dr. | University Hospital Zurich, Departement of Pulmonology | Principal Investigator |
| Rodrigo Hoyos, Dr. | Carlos Adrade Marin Hospital of Quito, Equador | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zürich | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39698150 | Derived | Muller J, Lichtblau M, Saxer S, Schmucki M, Furian M, Schneider SR, Herzig JJ, Bauer M, Saragoni D, Schwarz EI, Cajamarca E, Hoyos R, Ulrich S. The acute effect of high-dose supplemental oxygen on haemodynamics assessed by echocardiography in patients with pulmonary vascular disease living in Quito at 2850 m: a randomized, single-blind, placebo-controlled crossover trial. Eur Heart J Open. 2024 Dec 2;4(6):oeae097. doi: 10.1093/ehjopen/oeae097. eCollection 2024 Nov. |
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Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Otherwise, we will share anonymized research data after publication on a open access repository according to FAIR principles.
Decision about the best suitable plattform is ongoing.
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Each participant works as its own perfect control
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Sham SOT (placebo, ambient hypoxic air at 2840m) versus high-flow oxygen 10l/min both via a facial mask with reservoir will be applied
| Sham Oxygen therapy | Other | Patients will reveice pressurized air via a nasal cannula |
|
|
Change in right to left heart diameter ratio assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask |
| at 15 min of breathing ambient air or supplemental oxygen |
| Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs. placebo | Change in tricuspid annular plane systolic excursion (TAPSE) with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen |
| Change in right atrial area with SOT vs. placebo | Change in right atrial area by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen |
| Change in right heart strain with SOT vs. placebo | Change in in right heart strain by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen |
| Change in ph by arterial blood gases with SOT vs. placebo | Changes in ph by arterial blood gases SaO2, PaO2, PaCO2 with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen |
| Change in PaO2 by arterial blood gases with SOT vs. placebo | Changes in PaO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen |
| Change in PaCO2 by arterial blood gases with SOT vs. placebo | Changes in PaCO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask | at 15 min of breathing ambient air or supplemental oxygen |
| ID | Term |
|---|---|
| D065627 | Familial Primary Pulmonary Hypertension |
| D006976 | Hypertension, Pulmonary |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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