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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

May Pulseoximetry During Physical Exercise Predict Hypoxemia in COPD Patients During Air Travel?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896584
• Other study ID #: GK-40/3
• Secondary ID: S-08640b (REK)25
• Status: Completed
• Phase: N/A
• First received: May 8, 2009
• Last updated: November 17, 2010
• Start date: May 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: LHL Helse
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypoxemia
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Norway	Glittreklinikken	Hakadal

Sponsors (1)

Lead Sponsor	Collaborator
LHL Helse

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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. — View Citation

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. — View 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. — View Citation