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Effect of Normobaric Hypoxia and Hyperoxia in Patients With Pulmonary Hypertension

Effect of Normobaric Hypoxia and Hyperoxia on Pulmonary Hemodynamics in Patients With Pulmonary Hypertension

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03195959
Enrollment
44
Registered
2017-06-22
Start date
2017-06-22
Completion date
2022-05-01
Last updated
2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

Pulmonary arterial hypertension, Chronic thromboembolic pulmonary hypertension, Hypoxia, Hyperoxia

Brief summary

Pulmonary Hypertension (PH) is a severe disease with a bad prognosis. However, thanks to extensive research in this field, there are more and better treatment options that allow patients to participate in recreational activities at moderate altitude or bring up the question of air-travel. Still very few is known about the effects hypoxic conditions have on PH patients. The aim of this study is to investigate the effects of hypoxia in comparison to normoxia and hyperoxia on pulmonary hemodynamics in patients with pulmonary hypertension during routine right heart catheterisation. We aim to get insight into the pathophysiology of pulmonary hemodynamics under hypoxic conditions in comparison to normoxia and hyperoxia in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension compared with control patients, that are scheduled for right heart catheterisation due to dyspnea but have no PH.

Interventions

OTHERHypoxia and Hyperoxia

10 minutes of breathing a gas mixture with FiO2 0.16 via a tight fitting mask. After 10 minutes of breathing ambient air (normoxia), patients were exposed to hyperoxia (FiO2 1.0) for 10 minutes.

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* clinically indicated right heart catheterisation * diagnosis of pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension or control without pulmonary hypertension

Exclusion criteria

* hemodynamically unstable * partial pressure of Oxygen \< 7.3kPa * no informed consent * pulmonary hypertension due to left heart disease, chronic lung disease or miscellaneous (Groups II, III and V) according to Galié ERJ 2015

Design outcomes

Primary

MeasureTime frame
Change of pulmonary vascular resistance during hypoxia in comparison to normoxia and hyperoxiaDay 1

Secondary

MeasureTime frame
change of mean pulmonary artery pressure under hyperoxia in comparison to normoxia and hyperoxiaDay 1
change of the cardiac output under hyperoxia in comparison to normoxia and hyperoxiaDay 1
change of the partial pressure of carbon dioxide under hyperoxia in comparison to normoxia and hyperoxiaDay 1
change of the partial pressure of oxygen under hyperoxia in comparison to normoxia and hyperoxiaDay 1

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026