- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01019538
Pre-flight Titration of Supplemental Oxygen
July 3, 2011 updated by: Ullevaal University Hospital
COPD and Air Travel: Oxygen Equipment and Pre-flight Titration of Supplemental Oxygen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oslo, Norway, 0407
- Oslo University Hospital Ullevaal, Department of Pulmonary Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
COPD patients
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PaO2 obtained from oxygen titration during HAST vs hypobaric chamber
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ole H Skjønsberg, Prof.dr.med, Oslo University Hospital
- Principal Investigator: Aina Akerø, M.D., Oslo University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- Dine CJ, Kreider ME. Hypoxia altitude simulation test. Chest. 2008 Apr;133(4):1002-5. doi: 10.1378/chest.07-1354.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
November 23, 2009
First Submitted That Met QC Criteria
November 23, 2009
First Posted (Estimate)
November 25, 2009
Study Record Updates
Last Update Posted (Estimate)
July 6, 2011
Last Update Submitted That Met QC Criteria
July 3, 2011
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 897 (M.S.I. Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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