Clinical trial NCT02636465: Hypoxia in Flight Simulation in Obese Patients
Official title: Hypoxia in Flight Simulation in Obese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, COPD, OHS
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
Collaborators: name: Deutsche Luft und Raumfahrt
First posted: 2015-12-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese (BMI\>30 kg/m2) healthy adults, obese patients with obesity hypoventilation Syndrome, obese patients with COPD

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: desaturation (SaO2 in %) in flight simulation in obese patients
timeFrame: one hour each patient
Secondary outcomes:
measure: desaturation (SaO2 in %) in hypoxic chamber test versus hypoxia altitude Simulation test
timeFrame: one hour each patient
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Bethanien Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.