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Trials / Completed

CompletedNCT03574675

Acute Exposure of Simulated Hypoxia on Cardiac Output

Acute Exposure of Simulated Hypoxia on Non-invasive Cardiac Output Assessments at Rest and During Exercise

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
28 (actual)
Sponsor
University of Zurich · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FIO2: 15.1% = equivalent to 2500m above sea level) on non-invasive cardiac output assessments by Finapres® "NOVA" Technology at rest and under exercise.

Detailed description

Low altitude baseline measurements will be performed in Zurich (470m asl) including Echocardiography, right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise. Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device. During the exposure to simulated altitude (FiO2: 15.1%) and shamed altitude of 1 hour each, the participants cardiac output non-invasively assessed will be measured throughout the whole intervention.

Conditions

Interventions

TypeNameDescription
DEVICESimulated Altitude (FiO2: 15.1)Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
DEVICEShamed Hypoxia (FiO2: 20.9)Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.

Timeline

Start date
2018-05-02
Primary completion
2019-04-01
Completion
2019-04-01
First posted
2018-07-02
Last updated
2020-01-07

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03574675. Inclusion in this directory is not an endorsement.