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

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Simulated Altitude (FiO2: 15.1%)
Shamed Hypoxia (FiO2: 20.9)
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 Simulated 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: 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 Oxygen 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

Sites / Locations

  • Respiratory Clinic, University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Order air-hypoxia

Order hypoxia-air

Arm Description

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

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

Outcomes

Primary Outcome Measures

arterial blood oxygenation under simulated altitude at rest (FiO2: 15.1)
Difference in arterial blood oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%) at rest.
arterial blood oxygenation under simulated altitude at the time of exhaustion (FiO2: 15.1)
Difference in arterial blood oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%) at the time of exhaustion

Secondary Outcome Measures

Near infrared spectroscopy under simulated altitude at rest (FiO2: 15.1)
Difference in cerebral tissue oxygenation and muscle tissue oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%) at rest
Near infrared spectroscopy under simulated altitude at rest (FiO2: 15.1)
Difference in cerebral tissue oxygenation and muscle tissue oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%)

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
NCT03637114
Brief Title
Acute Exposure of Simulated Hypoxia 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
August 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Simulated 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 under simulated altitude and normoxia.
Masking
Participant
Masking Description
The allocated gas mixture will not be disclosed to the patient since he will breath through a facemask during both interventions.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Order air-hypoxia
Arm Type
Experimental
Arm Description
The participants will be exposed to shamed hypoxia (FiO2: 20.9% equivalent to sea level and consecutively to simulated altitude (FiO2: 15.1% equivalent to 2500m above sea level) administered by an altitude Simulator ("Altitrainer, SMTEC"), simulated altitude (FiO2: 15.1%), with a facemask.
Arm Title
Order hypoxia-air
Arm Type
Experimental
Arm Description
The participant will be exposed to hypoxia (FiO2, 15.1% equivalent to 2500m above sea level), simulated altitude (FiO2: 15.1%), and consecutively to shamed hypoxia (FiO2, 20.9%) administered by an altitude simulator ("Altitrainer, SMTEC") with a facemask.
Intervention Type
Device
Intervention Name(s)
Simulated Altitude (FiO2: 15.1%)
Intervention Description
Inhalation of deoxygenated air through a altitude simulator ("Altitrainer"), for approx. 1 hour. given by a facemask.
Intervention Type
Device
Intervention Name(s)
Shamed Hypoxia (FiO2: 20.9)
Intervention Description
Inhalation of unmodified air through an altitude Simulator ("Altitrainer") for approximately 1 hour given by a facemask
Primary Outcome Measure Information:
Title
arterial blood oxygenation under simulated altitude at rest (FiO2: 15.1)
Description
Difference in arterial blood oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%) at rest.
Time Frame
2 hours
Title
arterial blood oxygenation under simulated altitude at the time of exhaustion (FiO2: 15.1)
Description
Difference in arterial blood oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%) at the time of exhaustion
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Near infrared spectroscopy under simulated altitude at rest (FiO2: 15.1)
Description
Difference in cerebral tissue oxygenation and muscle tissue oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%) at rest
Time Frame
2 hours
Title
Near infrared spectroscopy under simulated altitude at rest (FiO2: 15.1)
Description
Difference in cerebral tissue oxygenation and muscle tissue oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%)
Time Frame
2 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: 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 Oxygen 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
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 of Simulated Hypoxia on Blood and Tissue Oxygenation (aBGA, NIRS)

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