Cystic Fibrosis and Fit-to-Fly

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

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2023-01-31

Brief Summary

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Due to the hypobaric hypoxia during air travel, some patients with Cystic Fibrosis (CF) need supplemental oxygen during air travel.

The study aims to evaluate if adding exercise desaturation to the pre-flight evaluation will help predict requirements for in-flight supplemental oxygen.

Detailed Description

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According to the British Thoracic Society (BTS) recommendations regarding pre-flight evaluation in patients with pulmonary disease, pre-flight arterial oxygen saturation or lung function tests do not discriminate sufficiently between those who need supplemental oxygen during flights, and those who can do without.Therefore, more extensively use of Hypoxia Altitude Simulation test (HAST) has been advocated. However, this test is not widely available. Previous studies have shown that exercise testing is useful for the prediction of in-flight hypoxemia. The investigators have previously developed a pre-flight algorithm for patients with chronic obstructive pulmonary disease (COPD), based on oxygen saturation measured by pulse oximetry at rest and during exercise (six minute walking test (6MWT)). It remains unknown as to whether these results are applicable to the CF population.

The current study aims to validate the pre-flight algorithm for patients with CF. Since a maximum cardiopulmonary exercise test (CPET) is recommended in the routine CF-control, the investigators also aim to evaluate whether the use of CPET predicts in-flight hypoxemia with greater accuracy than 6MWT, and whether CPET may replace HAST.

Conditions

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Cystic Fibrosis Hypoxemia Lung Diseases

Keywords

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Pre-flight evaluation Air travel Pulseoximetry Exercise desaturation Hypobaria Hypoxemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Pre-flight evaluation

All the participants receive the interventions as part of their routine medical care during their annual visit for CF follow-up. Oxygen saturation are measured by pulse oximetry. Exercise testing is performed by 6MWT and CPET. Pre-flight evaluation is performed by HAST.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult CF patients (age from 18 years)
* Signed informed consent

Exclusion Criteria

* Ongoing exacerbation
* Unable to fulfill a CPET or 6MWT
* Long-term oxygen treatment (LTOT)
* Severe heart disease
* Language problems that interfere with data collection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Aina Akerø

Principal Investigator, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aina Akerø, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, Dept. of Pulm. Med.

Locations

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Oslo University Hospital Ullevaal, Department of Pulmonary Medicine

Oslo, , Norway

Site Status

Countries

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Norway

References

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Edvardsen A, Akero A, Christensen CC, Ryg M, Skjonsberg OH. Air travel and chronic obstructive pulmonary disease: a new algorithm for pre-flight evaluation. Thorax. 2012 Nov;67(11):964-9. doi: 10.1136/thoraxjnl-2012-201855. Epub 2012 Jul 5.

Reference Type BACKGROUND

PMID: 22767877 (View on PubMed)

Ahmedzai S, Balfour-Lynn IM, Bewick T, Buchdahl R, Coker RK, Cummin AR, Gradwell DP, Howard L, Innes JA, Johnson AO, Lim E, Lim WS, McKinlay KP, Partridge MR, Popplestone M, Pozniak A, Robson A, Shovlin CL, Shrikrishna D, Simonds A, Tait P, Thomas M; British Thoracic Society Standards of Care Committee. Managing passengers with stable respiratory disease planning air travel: British Thoracic Society recommendations. Thorax. 2011 Sep;66 Suppl 1:i1-30. doi: 10.1136/thoraxjnl-2011-200295. No abstract available.

Reference Type BACKGROUND

PMID: 21856702 (View on PubMed)

Akero A, Edvardsen E, Finstad PL, Skrede B, Osterhaug M, Backman S, Edvardsen A, Skjonsberg OH. Air travel and cystic fibrosis: An algorithm to assess the risk of In-Flight Hypoxemia. J Cyst Fibros. 2025 Sep;24(5):963-969. doi: 10.1016/j.jcf.2025.05.004. Epub 2025 Jun 3.

Reference Type DERIVED

PMID: 40467430 (View on PubMed)

Other Identifiers

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2018/1607 (REK)

Identifier Type: -

Identifier Source: org_study_id