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Cystic Fibrosis and Fit-to-Fly (CyFF)

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Completed

Conditions

Lung Diseases
Cystic Fibrosis
Hypoxemia

Treatments

Other: Pre-flight evaluation

Study type

Observational

Funder types

Other

Identifiers

NCT03843723
2018/1607 (REK)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

79 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Ole Henning Skjønsberg, Prof Dr.Med MD; Aina Akerø, MD PhD

Data sourced from clinicaltrials.gov

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