NCT03637114

Acute Exposure of Simulated Hypoxia on Blood and Tissue Oxygenation (aBGA, NIRS)

Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects 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 arterial hypertension (PAH) and chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on blood and tissue oxygenation (ABGA, near infrared spectroscopy)

Detailed description

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas analysis. 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. At rest and under exercise data from ABGA and near infrared spectroscopy will be compared under simulated altitude and shamed altitude.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DEVICE	Simulated Altitude (FiO2: 15.1%)	Inhalation of deoxygenated air through a altitude simulator ("Altitrainer"), for approx. 1 hour. given by a facemask.
DEVICE	Shamed Hypoxia (FiO2: 20.9)	Inhalation of unmodified air through an altitude Simulator ("Altitrainer") for approximately 1 hour given by a facemask

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2018-08-17
• Last updated: 2020-01-07

Locations

1 site across 1 country: Switzerland