I27.0
Conditions
Interventions
Group 1: study day with 8 hours of hypobaric Hypoxia (HH) exposition
- Hourly clinical examination for patient safety
- Blood pressure, heart rate, blood oxygen level every 15 minutes
- Resting ECGs
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Sponsors
Uniklinik Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Signed informed consent form - Clinically stable disease for more than 3 months, assessed by the investigator - Right heart catheterisation with assessment of intracardiac blood pressure and haemodynamics within the last 24 months with PAPmean = 20 mmHg - Pulmonary hypertension with stable specific therapy for at least 4 weeks (Nice Class I), or pulmonary hypertension with left heart disease (Nice Class II), or chronic thromboembolic pulmonary hypertension (Nice Class IV)
Exclusion criteria
Exclusion criteria: - Hospitalisation due to cardiac decompensation within the last 3 months - Planned PTCA, ICD implantation, ACVB surgery within the next 90 days - Previous PTCA, cerebrovascular event (TIA, stroke) within the last 90 days - Hb 16 h/day (nocturnal oxygen administration permitted) - Chronic pleural effusion - Acute infectious disease, especially respiratory disease - Women who are pregnant or breastfeeding - Inability to follow the study procedures, e.g. due to speech problems, mental disorders, neurological or orthopaedic problems
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - Difference in the mean intraindividual change versus baseline in O2 saturation (capillary ABG measurement*; measured at 2-hour intervals, measured after 5 minutes of sitting) during the observation period of 8 hours of hypobaric hypoxia compared to normobaric normoxia (control) - Difference in the mean intraindividual change versus baseline of the ESQ IV symptom score (total score of the relevant components AMS-C, AMS-R, exertion, fatigue; measured in 4-hour intervals) during the observation period of 8 hours of hypobaric hypoxia compared to normobaric normoxia (control) - Difference in the mean intraindividual change versus baseline of the ESQ IV symptom score (total score of the other components Muscular Discomfort, Distress, Ear/Nose/Throat, Cold Stress, Alert; measured at 4-hour intervals) during the observation period of 8 hours of hypobaric hypoxia compared to normobaric normoxia (control) - Difference in the maximum intraindividual change versus baseline of the ESQ IV symptom score (total score of the other components Muscular Discomfort, Distress, Ear/Nose/Throat, Cold Stress, Alert; measured at 4-hour intervals) during the observation period of 8 hours of hypobaric hypoxia compared to normobaric normoxia (control) - Prevalence of symptoms, measured by ESQ IV symptom scores (analysis of all 9 components, collected in 4-hour intervals) during the observation period of 8 hours of hypobaric hypoxia compared to normobaric normoxia (control) - Intraindividual changes in vital signs after 2, 4, 6 and 8 hours vs. baseline (BL), in each case under hypobaric hypoxia compared to normoxia, such as - RR, pulse and peripherally derived blood oxygen saturation (1. conventional measurement method: clip on fingertip, earlobe; 2. telemedical method: smart watch (any model, photoplethysmographic sensor technology, analogue readout of measured values by examiner)) - 2018 Lake Louise AMS score (according to Roach et al.) after 3 and 6 hours vs. BL, both under hypobaric | — |
Primary
| Measure | Time frame |
|---|---|
| - Difference in the maximum intraindividual change versus baseline in O2 saturation (capillary ABG measurement*; measured at 2-hour intervals, measured after 5 minutes of sitting) during the observation period of 8 hours of hypobaric hypoxia compared to normobaric normoxia (control) - Difference in the maximum intraindividual change versus baseline of the ESQ IV symptom score (total score of the relevant components AMS-C, AMS-R, exertion, fatigue; measured in 4-hour intervals) during the observation period of 8 hours of hypobaric hypoxia compared to normobaric normoxia (control) | — |
Countries
Germany
Contacts
Public ContactStephan Rosenkranz
Uniklinik Köln
Outcome results
None listed