Pre-flight Titration of Supplemental Oxygen

NCT01019538 | Completed DMC

• 1 other identifier: 897
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Oxygen; Hypoxemia; Air travel

Outcome Measures

Primary Outcomes (1)

• PaO2 obtained from oxygen titration during HAST vs hypobaric chamber

  1 day

Interventions

Pre-flight test with supplemental oxygen OTHER

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.

Also known as: Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COPD patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ullevaal University Hospital: lead

Study Sites (1)

Oslo University Hospital Ullevaal, Department of Pulmonary Medicine

Oslo, Oslo County, 0407, Norway

Location

Related Publications (5)

• 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.

  PMID: 6508019 BACKGROUND

• 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.

  PMID: 15802350 BACKGROUND

• 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.

  PMID: 18500050 BACKGROUND

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

  PMID: 18398121 BACKGROUND

• 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.

  PMID: 21071527 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Arterial blood gases

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Ole H Skjønsberg, Prof.dr.med

  Oslo University Hospital

  STUDY DIRECTOR

• Aina Akerø, M.D.

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: December 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 6, 2011

Record last verified: 2009-11

Locations

NO (1)