- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02848391
Hypobaric Flight Simulation in COPD Patients
Impact of Hypobaric Flight Simulation on Walking Endurance in COPD Patients
Study Overview
Detailed Description
Background and aim:
Commercial aircrafts have their altitude compensation adjusted to 2500 meter above sea level which corresponds to a pressure difference of about 270 hPa. This causes a reduction of the partial pressure of oxygen during the flight. Patients with lung disease are especially challenged by large walking distances within airports and during their journey. The objective of our study is to evaluate the impact of a simulated flight under hyperbaric conditions on walking endurance in healthy individuals as well as in COPD Patients with and without hypercapnia.
Method:
Healthy individuals as well as COPD patients were assessed pre-flight with the following measurements:
- Arterial blood gas analysis
- Lung function test
- Lung diffusion test
- Hemoglobin level
- Six minute walking distance
During the flight measurements included (measured every 30 minutes until landing):
- Heartrate
- Oxygen saturation
- Borg scale
Post flight measurements included:
- Arterial blood gas analysis
- Six minute walking distance
Intended analysis:
- Description of endurance response as a function of COPD disease severity.
- Description of endurance response in normocapnic and hypercapnic COPD patients.
- Detection of pre-flight predictors that determine flight tolerability and hypoxic response.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
NRW
-
Schmallenberg, NRW, Germany, 57392
- Kloster Grafschaft
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- No lung disease
- COPD without hypercapnea
- COPD with hypercapnea
Exclusion Criteria:
- Claustrophobia
- Renal insufficiency
- Heart failure (ejection fraction < 45 %)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: healthy subjects
three hour flight simulation
|
hypobaric flight simulation
|
Experimental: COPD normocapnic
three hour flight simulation
|
hypobaric flight simulation
|
Experimental: COPD hypercapnic
three hour flight simulation
|
hypobaric flight simulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in six minute walking distance measured in meters
Time Frame: 30 Minutes before and after a 3 hour simulated flight (Time point - 30 and + 210 minutes)
|
difference between pre- and post-flight walking distance
|
30 Minutes before and after a 3 hour simulated flight (Time point - 30 and + 210 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
minimal Oxygen saturation measured by pulse oxymetry in %
Time Frame: measurement completed at 180 minutes
|
Nadir of the oxygen saturation during the flight
|
measurement completed at 180 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Airtravel01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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