Chronic Obstructive Pulmonary DiseaseNCT01019538
Pre-flight Titration of Supplemental Oxygen
An observational study of Chronic Obstructive Pulmonary Disease, run by Ullevaal University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pre-flight test with supplemental oxygen
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2008to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients
Who may be able to join
- COPD patients who have performed a Hypoxia-altitude simulation test with a PaO2 < 6.7 kPa
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital Ullevaal, Department of Pulmonary Medicine
Oslo, Oslo, 0407
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pre-flight test with supplemental oxygen
- Keywords
- Oxygen, Hypoxemia, Air travel
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-flight test with supplemental oxygenOther
Also called Oxygen
The Hypoxia-altitude simulation test, which is established in clinical practice, is compared to the gold standard of hypobaric chamber while giving supplemental gaseous oxygen without and with oxygen conserving device, and with oxygen concentrator.
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2 obtained from oxygen titration during HAST vs hypobaric chamber
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ole H Skjønsberg, Prof.dr.med, Study director, Oslo University HospitalAina Akerø, M.D., Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019538
- Sponsor's protocol ID
- 897
- Status last verified
- Nov 2009
- First submitted
- 23 Nov 2009
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 6508019Akero 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.
PubMed 15802350Akero 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.
PubMed 18500050Dine CJ, Kreider ME. Hypoxia altitude simulation test. Chest. 2008 Apr;133(4):1002-5. doi: 10.1378/chest.07-1354.
PubMed 18398121Akero 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.
PubMed 21071527
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD and Air Travel: Oxygen Equipment and Pre-flight Titration of Supplemental Oxygen
- ClinicalTrials.gov ID
- NCT01019538
- Acronym / sponsor ID
- 897
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Oxygen, Hypoxemia, Air travel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients
Key inclusion criteria (1 listed)
- COPD patients who have performed a Hypoxia-altitude simulation test with a PaO2 < 6.7 kPa
Key exclusion criteria (7 listed)
- exacerbation or pneumothorax within the previous six weeks
- LTOT
- anemia
- pulmonary disease other than COPD
- cerebrovascular or symptomatic cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-flight test with supplemental oxygenAlso: OxygenThe Hypoxia-altitude simulation test, which is established in clinical practice, is compared to the gold standard of hypobaric chamber while giving supplemental gaseous oxygen without and with oxygen conserving device, and with oxygen concentrator. | Other | – |
Primary outcome
PaO2 obtained from oxygen titration during HAST vs hypobaric chamber
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
- Background: PubMed 6508019Gong 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.
- Background: PubMed 15802350Akero 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.
- Background: PubMed 18500050Akero 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.
- Background: PubMed 18398121Dine CJ, Kreider ME. Hypoxia altitude simulation test. Chest. 2008 Apr;133(4):1002-5. doi: 10.1378/chest.07-1354.
- Derived from this study: PubMed 21071527Akero 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole H Skjønsberg, Prof.dr.med study director
Oslo University Hospital
Aina Akerø, M.D. principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2 obtained from oxygen titration during HAST vs hypobaric chamber (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01019538, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011; AzTrials last refreshed its copy on 6 Nov 2026.