Effect of Supplemental Oxygen Therapy (SOT) on 6-minute Walk Distance (6MWD) in Highlanders With High Altitude Pulmonary Hypertension Permanently Living at >2500m
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- 6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m
Study Overview
Brief Summary
The investigators aim to study the effect of SOT in highlanders with high altitude pulmonary hypertension (HAPH) who permanently live >2500m on 6-minute walk distance (6MWD) assessed at 3200m.
Detailed Description
Highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA (Tricuspid Regurgitation Pressure Gradient) >30 mmHg will be recruited for this project. Highlanders permanently living at HA >2500 m will perform a 6-minute walk distance test near their living altitude in Aksay at 3200 m with and without portable pulsed supplemental oxygen therapy (SOT) via nasal cannula according to a randomized cross-over design.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Permanently living >2500 m
- •HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
- •Written informed consent
Exclusion Criteria
- •Highlanders who cannot follow the study investigations,
- •Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, heavy smoking >20 cigarettes/day or >20 pack-years.
- •Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
- •Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)
Outcomes
Primary Outcomes
6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m
Time Frame: after 6 minute
Change in 6MWD in meters between SOT vs. ambient air at 3200 m
Secondary Outcomes
- Borg leg fatigue scale at end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)
- Blood pressure at rest and end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)
- Borg Dyspnea scale at end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)
- SpO2 at rest and end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)
- Heart rate at rest and end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)