Acute Exposure of Simulated Hypoxia on ECG and Non-invasive Blood Pressure

University of Zurich (UZH)

Status: Completed

Conditions: Pulmonary Hypertension

Treatments: Device: Shamed Hypoxia (FiO2: 20.9); Device: Simulated Altitude: (FiO2: 15.1)

Study type: Interventional

Funder types: Other

Identifiers

NCT03581851

2018-00455_A5

Details and patient eligibility

About

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 ECG repolarizations and non-invasive blood pressure measurements by Finapres® NOVA Technology.

Full description

Low altitude baseline measurements will be performed in Zurich (469m asl) including Echocardiography, right heart catheterization, six Minute Walking 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 e 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' ECG and non-invasively assessed blood pressure by Finapres at rest and under exercise will be collected.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent
• PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of initial diagnosis
• PH class 1 (PAH) or 4 (CTEPH)
• Stable condition, on the same medication for > 4 weeks
• Patient live permanently at an altitude < 1000m asl.

Exclusion criteria

• Resting partial O2 pressure (PaO2) ≤7.3 kiloPascal (kPA) corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed)
• Severe daytime hypercapnia (pCO2 > 6.5 kPa)
• Susceptibility to high altitude related diseases (AMS, High Altitude Pulmonary Edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
• Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation
• Residence > 1000m above sea level
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability
• Women who are pregnant or breast feeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Order Sham/Hypoxia

Experimental group

Description:

The participants will be consecutively exposed to shamed hypoxia (FiO2: 20.9%) equivalent to sea level and to simulated altitude (FiO2: 15.1%) equivalent to 2500m above sea level administered by an altitude simulator ("Altitrainer", SMTEC) with a facemask.

Treatment:

Device: Simulated Altitude: (FiO2: 15.1)

Device: Shamed Hypoxia (FiO2: 20.9)

Order Hypoxia/Sham

Experimental group

Description:

The participants will be consecutively exposed to hypoxia (FiO2: 15,1%) equivalent to 2500m above sea level and to shamed hypoxia (FiO2: 20.9%) equivalent to sea level administered by an altitude simulated ("Altitrainer", SMTEC) with a facemask.

Treatment:

Device: Simulated Altitude: (FiO2: 15.1)

Device: Shamed Hypoxia (FiO2: 20.9)