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Completed

NCT Number: NCT03843723

Cystic Fibrosis and Fit-to-Fly

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-flight evaluation

Other

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.

Primary outcomes

  1. Does oxygen saturation during exercise predict in-flight hypoxemia in adult patients with CF?

    Time frame: 1 day

    Oxygen saturation is measured by pulse oximetry (SpO2) during exercise and HAST

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian National Adivisory Unit on Rare Disorders
  • The Norwegian Resouce Centre for Cystic Fibrosis
  • University Hospital, Akershus

Registry information

Official study title

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

Acronym: CyFF

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2019
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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