Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Conditions
Keywords
Pulmonary Hypertension, Supplemental Oxygen Therapy, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, 6-Minute Walk Distance
Brief summary
The investigators aim to study the effect of liquid oxygen therapy (4l/min, nasal) )in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).
Detailed description
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 nasal liquid oxygen therapy (LOX) approximately 4l/min via nasal cannula according to a randomized cross-over design. The trial aims to test that the 6MWD with LOX is inferior to a 6MWD in the same participant under ambient air.
Interventions
6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards
6-minute walk test(6MWT) test will be performed according to clinical standards with supplemental liquid oxygen therapy (LOX, approximately 4l/min, nasal)
Sponsors
Silvia Ulrich Somaini
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Each participant serves as its own control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum 18 years of age * Written informed consent * Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH), chronic obstructive pulmonary disease (COPD) with emphysema, COPD without emphysema, or interstitial lung disease * Former desaturation under exercise defined as SpO2-decrease \>3% * Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)
Exclusion criteria
* Severe hypoxemia needing supplemental oxygen therapy defined as PaO2 \< 6.9 kPa * Inability or contraindications to undergo the investigated intervention * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, walk disability etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air | Distance will be measured at the end of 6 minutes from the 6MWT | Change in 6MWD in meter between supplemental liquid oxygen therapy (LOX) via nasal cannula vs. ambient air |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air | 6 minutes | Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with LOX approximately 4l /min vs. ambient air |
| Heart rate at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air | 6 minutes | Change of heart rate (bpm) at rest and at peak 6MWD with LOX vs. ambient air |
| Borg dyspnea at rest and peak 6MWT with supplemental liquid oxygen therapy (LOX) s. ambient air | after 6 minutes | Change of Borg dyspnea scale (CR10, 0-10 where 10 is the worst dyspnea) at rest and at peak 6MWD with LOX vs. ambient air |
| Borg leg fatigue scale at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air | 6 minutes | Change of Borg leg fatigue scale (CR10, 0-10 where 10 is the strongest led fatugue) at rest and at peak 6MWT with LOX vs. ambient air |
| Blood pressure at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air | 6 minutes | Change of blood pressure (mmHg) at rest and at peak 6MWD with LOX vs. ambient air |
Countries
Switzerland
Contacts
CONTACTSilvia Ulrich, Prof. Dr. med.
CONTACTMona Lichtblau, PD. Dr. med.
PRINCIPAL_INVESTIGATORSilvia Ulrich, Prof. Dr. med.
University Hospital Zurich, Department of Pulmonology
Outcome results
None listed