Hypobaric Flight Simulation in COPD Patients

February 28, 2018 updated by: Dominic Dellweg, M.D., Krankenhaus Kloster Grafschaft

Impact of Hypobaric Flight Simulation on Walking Endurance in COPD Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • NRW
      • Schmallenberg, NRW, Germany, 57392
        • Kloster Grafschaft

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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