Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)
- Conditions
- Chronic Thromboembolic Pulmonary HypertensionPulmonary Arterial HypertensionPulmonary Vascular Disorder
- Interventions
- Other: 6-minute walk distance (6MWD) test on ambient airOther: 6-minute walk distance test with supplemental oxygen
- Registration Number
- NCT06384534
- Lead Sponsor
- University of Zurich
- Brief Summary
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).
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 28
- Minimum 18 years of age
- Written informed consent
- Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH)
- 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)
- Severe hypoxemia needing supplemental oxygen therapy defined as partial pressure of O2 (PaO2) < 6.9 Kilopascal (kPa)
- Pregnancy
- Unability or contraindications to undergo the investigated intervention
- Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Ambient air 6-minute walk distance (6MWD) test on ambient air Patient will perform tests at University Hospital Zurich SOT via basal canula 6-minute walk distance test with supplemental oxygen 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.
- Primary Outcome Measures
Name Time Method 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air after 6 minutes Change in 6MWD in meter between SOT via nasal cannula vs. ambient air
- Secondary Outcome Measures
Name Time Method SpO2 at rest and peak 6MWD with SOT vs. ambient air after 6 minutes Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with SOT approximately 3l /min vs. ambient air
Heart rate at rest and peak 6MWD with SOT vs. ambient air after 6 minutes Change of heart rate (bpm) at rest and at peak 6MWD with SOT vs. ambient air
Borg dyspnea atrest and peak 6MWD with SOT vs. ambient air 6 minutes 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
Borg leg fatigue scale at rest and peak 6MWD with SOT 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 6MWD with SOT vs. ambient air
Blood pressure at rest and peak 6MWD with SOT vs. ambient air after 6 minutes Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT vs. ambient air
Trial Locations
- Locations (1)
University Hospital Zürich
🇨🇭Zurich, Switzerland