Exercise Pulseoximetry for Pre-flight Evaluation of Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00896584

First Posted: May 11, 2009

Last Update Posted: November 18, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

LHL Helse

Purpose

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.

Condition
Chronic Obstructive Pulmonary Disease Hypoxemia


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	May Pulseoximetry During Physical Exercise Predict Hypoxemia in COPD Patients During Air Travel?

Resource links provided by NLM:

MedlinePlus related topics: COPD Exercise and Physical Fitness Lung Diseases Traveler's Health

U.S. FDA Resources

Further study details as provided by LHL Helse:


Estimated Enrollment:	100
Study Start Date:	May 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

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

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

COPD patients

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896584

Locations


Norway
Glittreklinikken
Hakadal, Norway, 1485

Sponsors and Collaborators

LHL Helse

Investigators


Principal Investigator:	Anne Edvardsen, MSc	LHL Helse
Study Director:	Morten S Ryg, Dr philos	LHL Helse

More Information

Publications:

Akerø A, Christensen CC, Edvardsen A, Ryg M, Skjønsberg OH. Pulse oximetry in the preflight evaluation of patients with chronic obstructive pulmonary disease. Aviat Space Environ Med. 2008 May;79(5):518-24.

Akerø A, Christensen CC, Edvardsen A, Skjønsberg OH. Hypoxaemia in chronic obstructive pulmonary disease patients during a commercial flight. Eur Respir J. 2005 Apr;25(4):725-30.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Edvardsen A, Ryg M, Akerø A, Christensen CC, Skjønsberg 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.


Responsible Party:	Morten Ryg, Glittreklinikken
ClinicalTrials.gov Identifier:	NCT00896584 History of Changes
Other Study ID Numbers:	GK-40/3 S-08640b (REK) 2541 (Biobank) 2008/2/0079 (HelseRehab)
First Submitted:	May 8, 2009
First Posted:	May 11, 2009
Last Update Posted:	November 18, 2010
Last Verified:	November 2010

Keywords provided by LHL Helse:


Chronic obstructive pulmonary disease Hypoxemia Pre-flight evaluation Hypobaria	COPD Pulseoximetry Air travel Exercise desaturation

Additional relevant MeSH terms:


Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Anoxia	Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms

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