Cystic Fibrosis and Fit-to-Fly

Completed

• Conditions: Hypoxemia; Lung Diseases; Cystic Fibrosis

• Registration Number: NCT03843723
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-18
• Study Start: 2019-03-01
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Does oxygen saturation during exercise predict in-flight hypoxemia in adult patients with CF?	1 day	Oxygen saturation is measured by pulse oximetry (SpO2) during exercise and HAST

Trial Locations

Locations (1)

Oslo University Hospital Ullevaal, Department of Pulmonary Medicine; 🇳🇴 Oslo, Norway