We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pre-flight Titration of Supplemental Oxygen

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.
ClinicalTrials.gov Identifier: NCT01019538
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : July 6, 2011
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Other: Pre-flight test with supplemental 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.

Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: COPD and Air Travel: Oxygen Equipment and Pre-flight Titration of Supplemental Oxygen
Study Start Date : December 2008
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. PaO2 obtained from oxygen titration during HAST vs hypobaric chamber [ Time Frame: 1 day ]

Biospecimen Retention:   Samples Without DNA
Arterial blood gases

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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
Principal Investigator: Aina Akerø, M.D. Oslo University Hospital
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: November 2009

Keywords provided by Oslo University Hospital:
Oxygen
Hypoxemia
Air travel

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