Hypobaric Flight Simulation in COPD Patients

NCT ID: NCT02848391

Last Updated: 2018-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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COPD Hypoxia Aviation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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healthy subjects

three hour flight simulation

Group Type EXPERIMENTAL

Environmental

Intervention Type OTHER

hypobaric flight simulation

COPD normocapnic

three hour flight simulation

Group Type EXPERIMENTAL

Environmental

Intervention Type OTHER

hypobaric flight simulation

COPD hypercapnic

three hour flight simulation

Group Type EXPERIMENTAL

Environmental

Intervention Type OTHER

hypobaric flight simulation

Interventions

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Environmental

hypobaric flight simulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* No lung disease
* COPD without hypercapnea
* COPD with hypercapnea

Exclusion Criteria

* Claustrophobia
* Renal insufficiency
* Heart failure (ejection fraction \< 45 %)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Krankenhaus Kloster Grafschaft

OTHER

Sponsor Role lead

Responsible Party

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Dominic Dellweg, M.D.

PD Dr. med

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kloster Grafschaft

Schmallenberg, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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Airtravel01

Identifier Type: -

Identifier Source: org_study_id

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