Respiratory Clinic, University Hospital of Zurich
Zurich, 8091, Switzerland
NCT Number: NCT05112172
To study whether oxygen therapy titrated to maintain oxygenation (SpO2) > 90% at 2500m would resolve altitude-related adverse health effects, symptoms and impaired exercise during 30h exposure to high altitude.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Zurich, 8091, Switzerland
Patients with pulmonary hypertension who reveal an altitude-related adverse health effects at 2500m will be given oxygen therapy by nasal cannula titrated to maintain the oxygen saturation above 90%. The study will investigate, whether this measure will restore altitude-induced impairment to baseline levels at low altitude.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude
Time frame: 30 hours
Proportion of patients with precapillary pulmonary hypertension experiencing an ARAHE at 2500 m of high altitude and receiving oxygen therapy titrated to achieve SpO2 ≥ 90% who recover from ARAHE, have improved symptoms and achieve constant work-rate exercise time within a minimal important difference as defined for patients with respiratory disease within 1.75 min of baseline value at 490 m; time frame within 6 h after initiation of oxygen therapy.
Time frame: 30 hours
Difference with oxygen therapy at high altitude vs. low altitude in constant work-rate exercise time cycle exercise test at 75% Wmax at low altitude
Time frame: 30 hours
Difference with oxygen therapy at high altitude vs. low altitude in maximal exercise capacity during a incremental ramp cycle exercise test
Time frame: 30 hours
Difference with oxygen therapy at high altitude vs. low altitude in hemodynamics assessed by echocardiography at rest including pulmonary artery pressure, cardiac output, pulmonary vascular resistance and right heart function assessed as tricuspid plane systolic excursion and fractional area change.
Time frame: 30 hours
Difference with oxygen therapy at high altitude vs. low altitude baseline in post-exercise Borg dyspnoea scale going from 1-10 scores with higher values meaning worse dyspnea
Time frame: 30 hours
Difference with oxygen therapy at high altitude vs. low altitude baseline in symptoms assessed by the Visual Analogue Scale for dyspnoea, a 10cm line from left to right where patients have to add a cross-line with higher values meaning better feeling.
Time frame: 30 hours
Difference with oxygen therapy at high altitude vs. low altitude baseline in cognitive function tests
Time frame: 30 hours
Difference with oxygen therapy at high altitude vs. low altitude baseline in sit-to-stand test
Time frame: 30 hours
Difference with oxygen therapy at high altitude vs. low altitude in sleep disordered breathing
Time frame: 30 hours
Difference with oxygen therapy at high altitude vs. low altitude in 6 minute walk test
Time frame: 30 hours
Difference with oxygen therapy at high altitude vs. low altitude baseline in symptoms assessed by the Lake Louise acute mountain sickness score going from 0-12 points with mild AMS as 3-5 points, moderate AMS as 6-9 points, and severe AMS as 10-12 points.
University of Zurich
Other
The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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