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Hypobaric Flight Simulation in COPD Patients

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ClinicalTrials.gov Identifier: NCT02848391
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Dominic Dellweg, M.D., Krankenhaus Kloster Grafschaft

Brief Summary:
Aim of this study was to evaluate the hypoxic response during hypobaric flight simulation in normal individuals as well as in normocapnic and hypercapnic COPD patients as well as to evaluate the impact of a flight simulation on walking endurance in these patients.

Condition or disease Intervention/treatment Phase
COPD Hypoxia Aviation Other: Environmental Not Applicable

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:

  1. Arterial blood gas analysis
  2. Lung function test
  3. Lung diffusion test
  4. Hemoglobin level
  5. Six minute walking distance

During the flight measurements included (measured every 30 minutes until landing):

  1. Heartrate
  2. Oxygen saturation
  3. Borg scale

Post flight measurements included:

  1. Arterial blood gas analysis
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Hypobaric Flight Simulation on Walking Endurance in COPD Patients
Study Start Date : January 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: healthy subjects
three hour flight simulation
Other: Environmental
hypobaric flight simulation

Experimental: COPD normocapnic
three hour flight simulation
Other: Environmental
hypobaric flight simulation

Experimental: COPD hypercapnic
three hour flight simulation
Other: Environmental
hypobaric flight simulation




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. minimal Oxygen saturation measured by pulse oxymetry in % [ Time Frame: measurement completed at 180 minutes ]
    Nadir of the oxygen saturation during the flight



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No lung disease
  • COPD without hypercapnea
  • COPD with hypercapnea

Exclusion Criteria:

  • Claustrophobia
  • Renal insufficiency
  • Heart failure (ejection fraction < 45 %)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848391


Locations
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Germany
Kloster Grafschaft
Schmallenberg, NRW, Germany, 57392
Sponsors and Collaborators
Krankenhaus Kloster Grafschaft

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Responsible Party: Dominic Dellweg, M.D., PD Dr. med, Krankenhaus Kloster Grafschaft
ClinicalTrials.gov Identifier: NCT02848391    
Other Study ID Numbers: Airtravel01
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms