Hypobaric Flight Simulation in COPD Patients

Not Applicable

Completed

• Conditions: Aviation; COPD; Hypoxia
• Interventions: Other: Environmental

• Registration Number: NCT02848391
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Primary Completion: 2016-08
• Study Completion: 2017-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy subjects	Environmental	three hour flight simulation
COPD normocapnic	Environmental	three hour flight simulation
COPD hypercapnic	Environmental	three hour flight simulation

Primary Outcome Measures

Name	Time	Method
Change in six minute walking distance measured in meters	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

Name	Time	Method
minimal Oxygen saturation measured by pulse oxymetry in %	measurement completed at 180 minutes	Nadir of the oxygen saturation during the flight

Trial Locations

Locations (1)

Kloster Grafschaft; 🇩🇪 Schmallenberg, NRW, Germany