Pre-flight Titration of Supplemental Oxygen

NCT ID: NCT01019538

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Oxygen

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Oslo University Hospital, Ullevaal, Department of Pulmonary Medicine

Principal Investigators

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Ole H Skjønsberg, Prof.dr.med

Role: STUDY_DIRECTOR

Oslo University Hospital

Aina Akerø, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital Ullevaal, Department of Pulmonary Medicine

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

References

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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. doi: 10.1164/arrd.1984.130.6.980.

Reference Type BACKGROUND
PMID: 6508019 (View on PubMed)

Akero A, Christensen CC, Edvardsen A, Skjonsberg OH. Hypoxaemia in chronic obstructive pulmonary disease patients during a commercial flight. Eur Respir J. 2005 Apr;25(4):725-30. doi: 10.1183/09031936.05.00093104.

Reference Type BACKGROUND
PMID: 15802350 (View on PubMed)

Akero A, Christensen CC, Edvardsen A, Ryg M, Skjonsberg OH. Pulse oximetry in the preflight evaluation of patients with chronic obstructive pulmonary disease. Aviat Space Environ Med. 2008 May;79(5):518-24. doi: 10.3357/asem.2120.2008.

Reference Type BACKGROUND
PMID: 18500050 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 18398121 (View on PubMed)

Akero A, Edvardsen A, Christensen CC, Owe JO, Ryg M, Skjonsberg OH. COPD and air travel: oxygen equipment and preflight titration of supplemental oxygen. Chest. 2011 Jul;140(1):84-90. doi: 10.1378/chest.10-0965. Epub 2010 Nov 11.

Reference Type DERIVED
PMID: 21071527 (View on PubMed)

Other Identifiers

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897

Identifier Type: -

Identifier Source: org_study_id

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