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

NCT03600415 | Completed

• 1 other identifier: 2018-00455_B5
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Hypertension

Keywords

High Altitude; arterial blood gas analysis; near infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• Arterial blood oxygenation at High Altitude (2500m above sea level)

  Difference in arterial blood oxygenation at Low Altitude (Zurich, 470m above sea level) and High Altitude (Säntis; 2500m above sea level)

  within 5 hours

Secondary Outcomes (1)

• Near infrared spectroscopy at High Altitude (2500m)

  within 5 hours

Study Arms (2)

Order A

EXPERIMENTAL

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

Other: Low altitude: 470m above sea level; Other: Säntis; 2500m above sea level

Order B

EXPERIMENTAL

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

Other: Low altitude: 470m above sea level; Other: Säntis; 2500m above sea level

Interventions

Low altitude: 470m above sea level OTHER

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

Order A; Order B

Säntis; 2500m above sea level OTHER

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

Order A; Order B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Altitude Sickness

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders

Study Officials

• Silvia Ulrich, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Including a baseline assessment and assessments at Low altitude and High altitude

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 26, 2018
• Study Start: July 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

CH (1)