Pre-flight Titration of Supplemental Oxygen

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

COPD and Air Travel: Oxygen Equipment and Pre-flight Titration of Supplemental Oxygen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019538
• Other study ID #: 897
• Status: Completed
• Phase: N/A
• First received: November 23, 2009
• Last updated: July 3, 2011
• Start date: December 2008
• Est. completion date: April 2010

Study information

• Verified date: November 2009
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate if supplemental oxygen during air travel can be reliably titrated using a Hypoxia-altitude simulation test (HAST). Also, the effect of oxygen supplementation given with the various oxygen equipment allowed for air travel is studied.

Description:

International guidelines recommend supplemental oxygen if PaO2 < 6.7 kPa (50 mmHg) during air travel. Hypobaric chamber exposure is the ideal test but is not widely available. In clinical practice, the HAST has been recommended as the preferable test for pre-flight evaluation, and is used with increasing frequency. The oxygen dose during air travel has been recommended titrated during HAST. In the study, supplemental oxygen titration during hypobaric chamber exposure is compared to oxygen titration during HAST, to evaluate if HAST can be used with confidence to titrate the amount of supplemental oxygen needed during air travel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COPD patients who have performed a Hypoxia-altitude simulation test with a PaO2 < 6.7 kPa

Exclusion Criteria:

• exacerbation or pneumothorax within the previous six weeks

• LTOT

• anemia

• pulmonary disease other than COPD

• cerebrovascular or symptomatic cardiovascular disease

• claustrophobia

• inability to equalize pressure in the middle ear

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• Pre-flight test with supplemental oxygen
The Hypoxia-altitude simulation test, which is established in clinical practice, is compared to the gold standard of hypobaric chamber while giving supplemental gaseous oxygen without and with oxygen conserving device, and with oxygen concentrator.

Locations

Country	Name	City	State
Norway	Oslo University Hospital Ullevaal, Department of Pulmonary Medicine	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (4)

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

Dine CJ, Kreider ME. Hypoxia altitude simulation test. Chest. 2008 Apr;133(4):1002-5. doi: 10.1378/chest.07-1354. Review. — View Citation

Gong H Jr, Tashkin DP, Lee EY, Simmons MS. Hypoxia-altitude simulation test. Evaluation of patients with chronic airway obstruction. Am Rev Respir Dis. 1984 Dec;130(6):980-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2 obtained from oxygen titration during HAST vs hypobaric chamber		1 day	No