Hypobaric Flight Simulation in COPD Patients

COPD Clinical Trial

Official title:

Impact of Hypobaric Flight Simulation on Walking Endurance in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848391
• Other study ID #: Airtravel01
• Status: Completed
• Phase: N/A
• First received: June 24, 2016
• Last updated: February 28, 2018
• Start date: January 2013
• Est. completion date: September 2017

Study information

• Verified date: February 2018
• Source: Krankenhaus Kloster Grafschaft
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• No lung disease

• COPD without hypercapnea

• COPD with hypercapnea

Exclusion Criteria:

• Claustrophobia

• Renal insufficiency

• Heart failure (ejection fraction < 45 %)

Related Conditions & MeSH terms

• Aviation
• COPD
• Hypoxia

Intervention

Other:
• Environmental
hypobaric flight simulation

Locations

Country	Name	City	State
Germany	Kloster Grafschaft	Schmallenberg	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Kloster Grafschaft

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	minimal Oxygen saturation measured by pulse oxymetry in %	Nadir of the oxygen saturation during the flight	measurement completed at 180 minutes