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

This study has been completed.
Sponsor:
Information provided by:
LHL Helse
ClinicalTrials.gov Identifier:
NCT00896584
First received: May 8, 2009
Last updated: November 17, 2010
Last verified: November 2010
  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:


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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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)
Study First Received: May 8, 2009
Last Updated: November 17, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on September 11, 2014