NCT00896584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

November 18, 2010

Status Verified

November 1, 2010

Enrollment Period

1.5 years

First QC Date

May 8, 2009

Last Update Submit

November 17, 2010

Conditions

Keywords

Chronic obstructive pulmonary diseaseHypoxemiaPre-flight evaluationHypobariaCOPDPulseoximetryAir travelExercise desaturation

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

COPD patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glittreklinikken

Hakadal, Hakadal, 1485, Norway

Location

Related Publications (4)

  • 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.

    PMID: 18500050BACKGROUND
  • 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.

    PMID: 15802350BACKGROUND
  • 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.

    PMID: 11923546BACKGROUND
  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypoxia

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Anne Edvardsen, MSc

    LHL Helse

    PRINCIPAL INVESTIGATOR
  • Morten S Ryg, Dr philos

    LHL Helse

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 11, 2009

Study Start

May 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 18, 2010

Record last verified: 2010-11

Locations