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OpenTrials
Completed

NCT Number: NCT02848391

Hypobaric Flight Simulation 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kloster Grafschaft

Schmallenberg, North Rhine-Westphalia, 57392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Environmental

Other

hypobaric flight simulation

Primary outcomes

  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 outcomes

  1. minimal Oxygen saturation measured by pulse oxymetry in %

    Time frame: measurement completed at 180 minutes

    Nadir of the oxygen saturation during the flight

Sponsors and collaborators

Lead sponsor

Krankenhaus Kloster Grafschaft

Other

Registry information

Official study title

Impact of Hypobaric Flight Simulation on Walking Endurance in COPD Patients

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jul 28, 2016
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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