Hypobaric Flight Simulation in COPD Patients

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: Hypoxia; COPD; Aviation
• Intervention / Treatment: Other: Environmental

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in six minute walking distance measured in meters	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 %	Nadir of the oxygen saturation during the flight	measurement completed at 180 minutes

Collaborators and Investigators

• Sponsor: Krankenhaus Kloster Grafschaft

Study record dates

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: Signs and Symptoms, Respiratory; Hypoxia
• 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