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Pre-flight Titration of Supplemental Oxygen
This study has been completed.

First Received on November 23, 2009.   Last Updated on July 3, 2011   History of Changes
Sponsor: Ullevaal University Hospital
Information provided by: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01019538
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Other: Pre-flight test with supplemental oxygen

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: COPD and Air Travel: Oxygen Equipment and Pre-flight Titration of Supplemental Oxygen

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Oxygen Therapy Traveler's Health
U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • PaO2 obtained from oxygen titration during HAST vs hypobaric chamber [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Arterial blood gases


Estimated Enrollment: 20
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Oxygen
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

COPD patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019538

Locations
Norway
Oslo University Hospital Ullevaal, Department of Pulmonary Medicine
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Director: Ole H Skjønsberg, Prof.dr.med Oslo University Hospital Ullevaal
Principal Investigator: Aina Akerø, M.D. Oslo University Hospital Ullevaal
  More Information

Publications:
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.
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.
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.
Dine CJ, Kreider ME. Hypoxia altitude simulation test. Chest. 2008 Apr;133(4):1002-5. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Akerø A, Edvardsen A, Christensen CC, Owe JO, Ryg M, Skjønsberg OH. COPD and air travel: oxygen equipment and preflight titration of supplemental oxygen. Chest. 2011 Jul;140(1):84-90. Epub 2010 Nov 11.

Responsible Party: Ole Henning Skjønsberg, Prof., dr.med, Oslo University Hospital, Ullevaal, Department of Pulmonary Medicine
ClinicalTrials.gov Identifier: NCT01019538     History of Changes
Other Study ID Numbers: 897
Study First Received: November 23, 2009
Last Updated: July 3, 2011
Health Authority: Norway: The National Committees for Research Ethics in Norway

Keywords provided by Oslo University Hospital:
Oxygen
Hypoxemia
Air travel

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 24, 2012



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