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Hypoxia in Flight Simulation in Obese Patients

NCT ID: NCT02636465

Last Updated: 2015-12-21

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

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-02-28

Brief Summary

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The purpose of this pilot study is to determine whether obese adults,obese (BMI\>30 kg/m2) with obesity hypoventilation or obese COPD-patients do undergo oxygen desaturation under flight simulation and if the hypoxic altitude simulation test is as effective as the hypoxic chamber test.

Detailed Description

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Conditions

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Obesity, COPD, OHS

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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obese healthy adults

persons with BMI\> 30 kg/m2

flight simulationin obese healthy adults or obese patients with or without COPD, OHS

Intervention Type OTHER

obese COPD patients

COPD-patients (GOLD I-IV Group A-D) with BMI\> 30 kg/m2

flight simulationin obese healthy adults or obese patients with or without COPD, OHS

Intervention Type OTHER

OHS-patients

patients with defined OHS: BMI\>30 kg/m2 and sleep related breathing disease, no COPD

flight simulationin obese healthy adults or obese patients with or without COPD, OHS

Intervention Type OTHER

Interventions

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flight simulationin obese healthy adults or obese patients with or without COPD, OHS

Intervention Type OTHER

Other Intervention Names

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flight simulation

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years
* patients with COPD (GOLD I-IV Group A-D) with obesity (BMI\> 30kg/m2), obese healthy adults with BMI\> 30kg /m2, patients with Obesity hypoventilation syndrome
* informed consent provided

Exclusion Criteria

* patients less than BMI \<30 kg/m2 with or without COPD, OHS
* Age \< 18 years
* pregnancy, lactation
* any medical, psychological or other condition restricting the patient's ability to provide informed consent
* participation in another clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Deutsche Luft und Raumfahrt

OTHER_GOV

Sponsor Role collaborator

Wissenschaftliches Institut Bethanien e.V

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bethanien Hospital

Solingen, , Germany

Site Status

Countries

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Germany

References

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Edvardsen A, Ryg M, Akero A, Christensen CC, Skjonsberg OH. COPD and air travel: does hypoxia-altitude simulation testing predict in-flight respiratory symptoms? Eur Respir J. 2013 Nov;42(5):1216-23. doi: 10.1183/09031936.00157112. Epub 2012 Dec 20.

Reference Type BACKGROUND
PMID: 23258777 (View on PubMed)

Edvardsen A, Akero A, Christensen CC, Ryg M, Skjonsberg OH. Air travel and chronic obstructive pulmonary disease: a new algorithm for pre-flight evaluation. Thorax. 2012 Nov;67(11):964-9. doi: 10.1136/thoraxjnl-2012-201855. Epub 2012 Jul 5.

Reference Type BACKGROUND
PMID: 22767877 (View on PubMed)

Edvardsen A, Akero A, Hardie JA, Ryg M, Eagan TM, Skjonsberg OH, Bakke PS. High prevalence of respiratory symptoms during air travel in patients with COPD. Respir Med. 2011 Jan;105(1):50-6. doi: 10.1016/j.rmed.2010.10.006. Epub 2010 Oct 25.

Reference Type BACKGROUND
PMID: 20974527 (View on PubMed)

Howard LS. Last call for the flight simulation test? Eur Respir J. 2013 Nov;42(5):1175-7. doi: 10.1183/09031936.00037813. No abstract available.

Reference Type BACKGROUND
PMID: 24178931 (View on PubMed)

Ahmedzai S, Balfour-Lynn IM, Bewick T, Buchdahl R, Coker RK, Cummin AR, Gradwell DP, Howard L, Innes JA, Johnson AO, Lim E, Lim WS, McKinlay KP, Partridge MR, Popplestone M, Pozniak A, Robson A, Shovlin CL, Shrikrishna D, Simonds A, Tait P, Thomas M; British Thoracic Society Standards of Care Committee. Managing passengers with stable respiratory disease planning air travel: British Thoracic Society recommendations. Thorax. 2011 Sep;66 Suppl 1:i1-30. doi: 10.1136/thoraxjnl-2011-200295. No abstract available.

Reference Type BACKGROUND
PMID: 21856702 (View on PubMed)

Other Identifiers

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WI_105/2013

Identifier Type: -

Identifier Source: org_study_id