Clinical trial NCT00896584: Exercise Pulseoximetry for Pre-flight Evaluation of Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: May Pulseoximetry During Physical Exercise Predict Hypoxemia in COPD Patients During Air Travel?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Hypoxemia
Keywords: Chronic obstructive pulmonary disease
Hypoxemia
Pre-flight evaluation
Hypobaria
COPD
Pulseoximetry
Air travel
Exercise desaturation
Lead sponsor: LHL Helse
Sponsor class: OTHER
First posted: 2009-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
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: 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.

Eligibility criteria: Inclusion Criteria:

* patients with COPD who have performed a hypoxia altitude simulation test
* able to perform the 6-minute walking test

Exclusion Criteria:

* unstable angina
* uncontrolled hypertension
* uncontrolled arrythmia
* patients with long-term oxygen treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hakadal
country: Norway
facility: Glittreklinikken
Study officials:
affiliation: LHL Helse
name: Anne Edvardsen, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: LHL Helse
name: Morten S Ryg, Dr philos
role: STUDY_DIRECTOR
References:
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: 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: British 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.
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.