Clinical trial NCT01019538: Pre-flight Titration of Supplemental Oxygen
Official title: COPD and Air Travel: Oxygen Equipment and Pre-flight Titration of Supplemental Oxygen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Oxygen
Hypoxemia
Air travel
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients

Brief summary: The purpose of this study is to evaluate if supplemental oxygen during air travel can be reliably titrated using a Hypoxia-altitude simulation test (HAST). Also, the effect of oxygen supplementation given with the various oxygen equipment allowed for air travel is studied.

Detailed description: International guidelines recommend supplemental oxygen if PaO2 \< 6.7 kPa (50 mmHg) during air travel. Hypobaric chamber exposure is the ideal test but is not widely available. In clinical practice, the HAST has been recommended as the preferable test for pre-flight evaluation, and is used with increasing frequency. The oxygen dose during air travel has been recommended titrated during HAST. In the study, supplemental oxygen titration during hypobaric chamber exposure is compared to oxygen titration during HAST, to evaluate if HAST can be used with confidence to titrate the amount of supplemental oxygen needed during air travel.

Eligibility criteria: Inclusion Criteria:

* COPD patients who have performed a Hypoxia-altitude simulation test with a PaO2 \< 6.7 kPa

Exclusion Criteria:

* exacerbation or pneumothorax within the previous six weeks
* LTOT
* anemia
* pulmonary disease other than COPD
* cerebrovascular or symptomatic cardiovascular disease
* claustrophobia
* inability to equalize pressure in the middle ear

Primary outcomes:
measure: PaO2 obtained from oxygen titration during HAST vs hypobaric chamber
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital Ullevaal, Department of Pulmonary Medicine
Study officials:
affiliation: Oslo University Hospital
name: Ole H Skjønsberg, Prof.dr.med
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: Aina Akerø, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gong H Jr, Tashkin DP, Lee EY, Simmons MS. Hypoxia-altitude simulation test. Evaluation of patients with chronic airway obstruction. Am Rev Respir Dis. 1984 Dec;130(6):980-6. doi: 10.1164/arrd.1984.130.6.980.
citation: Akero A, Christensen CC, Edvardsen A, Skjonsberg OH. Hypoxaemia in chronic obstructive pulmonary disease patients during a commercial flight. Eur Respir J. 2005 Apr;25(4):725-30. doi: 10.1183/09031936.05.00093104.
citation: Akero A, Christensen CC, Edvardsen A, Ryg M, Skjonsberg OH. Pulse oximetry in the preflight evaluation of patients with chronic obstructive pulmonary disease. Aviat Space Environ Med. 2008 May;79(5):518-24. doi: 10.3357/asem.2120.2008.
citation: Dine CJ, Kreider ME. Hypoxia altitude simulation test. Chest. 2008 Apr;133(4):1002-5. doi: 10.1378/chest.07-1354.
citation: Akero A, Edvardsen A, Christensen CC, Owe JO, Ryg M, Skjonsberg OH. COPD and air travel: oxygen equipment and preflight titration of supplemental oxygen. Chest. 2011 Jul;140(1):84-90. doi: 10.1378/chest.10-0965. Epub 2010 Nov 11.