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

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Low altitude: 470m above sea level
Säntis; 2500m above sea level
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Hypertension focused on measuring High Altitude, arterial blood gas analysis, near infrared spectroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Respiratory Clinic, University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Order A

Order B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Near infrared spectroscopy at High Altitude (2500m)
Difference in cerebral tissue oxygenation and muscle tissue oxygenation measured by near infrared spectroscopy at low Altitude (Zurich) and High Altitude (Säntis, 2500m)

Full Information

First Posted
July 9, 2018
Last Updated
January 6, 2020
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03600415
Brief Title
Acute Exposure to High Altitude on Blood and Tissue Oxygenation (ABGA, NIRS)
Official Title
Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
High Altitude, arterial blood gas analysis, near infrared spectroscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Including a baseline assessment and assessments at Low altitude and High altitude
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Order A
Arm Type
Experimental
Arm Description
The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(Säntis; 2500m above sea Level)
Arm Title
Order B
Arm Type
Experimental
Arm Description
The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level).
Intervention Type
Other
Intervention Name(s)
Low altitude: 470m above sea level
Intervention Description
Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
Intervention Type
Other
Intervention Name(s)
Säntis; 2500m above sea level
Intervention Description
Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours
Primary Outcome Measure Information:
Title
Arterial blood oxygenation at High Altitude (2500m above sea level)
Description
Difference in arterial blood oxygenation at Low Altitude (Zurich, 470m above sea level) and High Altitude (Säntis; 2500m above sea level)
Time Frame
within 5 hours
Secondary Outcome Measure Information:
Title
Near infrared spectroscopy at High Altitude (2500m)
Description
Difference in cerebral tissue oxygenation and muscle tissue oxygenation measured by near infrared spectroscopy at low Altitude (Zurich) and High Altitude (Säntis, 2500m)
Time Frame
within 5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich, Prof.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiratory Clinic, University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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

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