Acute Exposure to High Altitude on Blood and Tissue Oxygenation (ABGA, NIRS)

NCT ID: NCT03600415

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-01-01

Brief Summary

Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) on blood and tissue oxygenation (ABGA, NIRS).

Detailed Description

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

At rest and under exercise data from ABGA and NIRS will be compared at low altitude and High Altitude.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Order A

The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(Säntis; 2500m above sea Level)

Group Type: EXPERIMENTAL

Low altitude: 470m above sea level

Intervention Type: OTHER

Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure

Säntis; 2500m above sea level

Intervention Type: OTHER

Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours

Order B

The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level).

Group Type: EXPERIMENTAL

Low altitude: 470m above sea level

Intervention Type: OTHER

Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure

Säntis; 2500m above sea level

Intervention Type: OTHER

Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours

Interventions

Low altitude: 470m above sea level

Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure

Intervention Type: OTHER

Säntis; 2500m above sea level

Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Informed consent
• PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a 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 PaO2 ≤7.3 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, 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia Ulrich, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Respiratory Clinic, University Hospital of Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2018-00455_B5

Identifier Type: -

Identifier Source: org_study_id