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Cystic Fibrosis and Fit-to-Fly

Exercise Pulse Oximetry and Pre-flight Evaluation of Adult Cystic Fibrosis (CF) Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03843723
Acronym
CyFF
Enrollment
79
Registered
2019-02-18
Start date
2019-03-01
Completion date
2023-01-31
Last updated
2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Hypoxemia, Lung Diseases

Keywords

Pre-flight evaluation, Air travel, Pulseoximetry, Exercise desaturation, Hypobaria, Hypoxemia

Brief summary

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

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.

Interventions

OTHERPre-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.

Sponsors

The Norwegian Resouce Centre for Cystic Fibrosis
CollaboratorUNKNOWN
Norwegian National Adivisory Unit on Rare Disorders
CollaboratorUNKNOWN
University Hospital, Akershus
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Does oxygen saturation during exercise predict in-flight hypoxemia in adult patients with CF?1 dayOxygen saturation is measured by pulse oximetry (SpO2) during exercise and HAST

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026