Chronic Obstructive Pulmonary DiseaseNCT00896584
Exercise Pulseoximetry for Pre-flight Evaluation of Chronic Obstructive Pulmonary Disease (COPD) Patients
An observational study of Chronic Obstructive Pulmonary Disease and Hypoxemia, run by LHL Helse at 1 site in Norway.
Trial summary
Some patients with chronic obstructive pulmonary disease (COPD) need supplementary oxygen during air travel. Guidelines issued by The British Thoracic Society (BTS) for pre-flight evaluation do not discriminate sufficiently between those who need supplementary oxygen during flight, and those who can do without. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Hypoxemia
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- May 2009to Nov 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients
Who may be able to join
- patients with COPD who have performed a hypoxia altitude simulation test
- able to perform the 6-minute walking test
Who cannot join
- unstable angina
- uncontrolled hypertension
- uncontrolled arrythmia
- patients with long-term oxygen treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: May Pulseoximetry During Physical Exercise Predict Hypoxemia in COPD Patients During Air Travel?
Some patients with chronic obstructive pulmonary disease (COPD) need supplementary oxygen during air travel. Guidelines issued by The British Thoracic Society (BTS) for pre-flight evaluation do not discriminate sufficiently between those who need supplementary oxygen during flight, and those who can do without. Previous studies have indicated that decreasing hemoglobin oxygen saturation during exercise may predict in-flight hypoxemia. The objective of the present study is to examine if adding exercise oxygen desaturation to the BTS algorithm will better predict requirements for in-flight supplementary oxygen.
Read the detailed description
The British Thoracic Society (BTS) guidelines on pre-flight evaluation for patients with chronic respiratory disease is based on an algorithm where arterial oxygen saturation is the discriminating factor. It has recently been shown that this algorithm does not discriminate sufficiently between patients who need pre-flight evaluation and maybe supplementary oxygen during air travel, and those who can travel by air without supplemental oxygen or further evaluation. Studies have also shown that exercise desaturation may predict in-flight hypoxemia. The objective of the present study is to examine if inclusion of arterial oxygen saturation measured by pulseoximetry during exercise in the BTS algorithm, will increase the sensitivity and specificity of the BTS pre-flight evaluation guidelines.The study also include questionnaires on symptoms during air travel carried out before ande after the pre-flight evaluation.
- Conditions
- Chronic Obstructive Pulmonary Disease, Hypoxemia
- Keywords
- Chronic obstructive pulmonary disease, Hypoxemia, Pre-flight evaluation, Hypobaria, COPD, Pulseoximetry, Air travel, Exercise desaturation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoxia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LHL Helse
- Sponsor type
- University, hospital or other
- Investigators
- Anne Edvardsen, MSc, Principal investigator, LHL HelseMorten S Ryg, Dr philos, Study director, LHL Helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896584
- Sponsor's protocol ID
- GK-40/3
- Other IDs
- S-08640b (REK), 2541 (Biobank), 2008/2/0079 (HelseRehab)
- Status last verified
- Nov 2010
- First submitted
- 8 May 2009
- Last updated
- 18 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18500050Akero 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 15802350British Thoracic Society Standards of Care Committee. Managing passengers with respiratory disease planning air travel: British Thoracic Society recommendations. Thorax. 2002 Apr;57(4):289-304. doi: 10.1136/thorax.57.4.289. No abstract available.
PubMed 11923546Edvardsen 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.
PubMed 23258777
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- May Pulseoximetry During Physical Exercise Predict Hypoxemia in COPD Patients During Air Travel?
- ClinicalTrials.gov ID
- NCT00896584
- Acronym / sponsor ID
- GK-40/3
- Conditions
- Chronic Obstructive Pulmonary Disease, Hypoxemia
- Keywords
- Chronic obstructive pulmonary disease, Hypoxemia, Pre-flight evaluation, Hypobaria, COPD, Pulseoximetry, Air travel, Exercise desaturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LHL HelseUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 May 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.
Some patients with chronic obstructive pulmonary disease (COPD) need supplementary oxygen during air travel. Guidelines issued by The British Thoracic Society (BTS) for pre-flight evaluation do not discriminate sufficiently between those who need supplementary oxygen during flight, and those who can do without. Previous studies have indicated that decreasing hemoglobin oxygen saturation during exercise may predict in-flight hypoxemia. The objective of the present study is to examine if adding exercise oxygen desaturation to the BTS algorithm will better predict requirements for in-flight supplementary oxygen.
Detailed description
The British Thoracic Society (BTS) guidelines on pre-flight evaluation for patients with chronic respiratory disease is based on an algorithm where arterial oxygen saturation is the discriminating factor. It has recently been shown that this algorithm does not discriminate sufficiently between patients who need pre-flight evaluation and maybe supplementary oxygen during air travel, and those who can travel by air without supplemental oxygen or further evaluation. Studies have also shown that exercise desaturation may predict in-flight hypoxemia. The objective of the present study is to examine if inclusion of arterial oxygen saturation measured by pulseoximetry during exercise in the BTS algorithm, will increase the sensitivity and specificity of the BTS pre-flight evaluation guidelines.The study also include questionnaires on symptoms during air travel carried out before ande after the pre-flight evaluation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients
Key inclusion criteria (2 listed)
- patients with COPD who have performed a hypoxia altitude simulation test
- able to perform the 6-minute walking test
Key exclusion criteria (4 listed)
- unstable angina
- uncontrolled hypertension
- uncontrolled arrythmia
- patients with long-term oxygen treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 18 Nov 2010.
- 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 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 11923546British Thoracic Society Standards of Care Committee. Managing passengers with respiratory disease planning air travel: British Thoracic Society recommendations. Thorax. 2002 Apr;57(4):289-304. doi: 10.1136/thorax.57.4.289. No abstract available.
- Derived from this study: PubMed 23258777Edvardsen 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.
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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.
Anne Edvardsen, MSc principal investigator
LHL Helse
Morten S Ryg, Dr philos study director
LHL Helse
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 and Hypoxemia, run by LHL Helse 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 2 inclusion and 4 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 18 Nov 2010. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00896584, which also lists 4 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 18 Nov 2010.