Cystic Fibrosis and Fit-to-Fly

Cystic Fibrosis Clinical Trial

— CyFF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843723
• Other study ID #: 2018/1607 (REK)
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: December 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Hypoxemia
• Hypoxia
• Lung Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital Ullevaal, Department of Pulmonary Medicine	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian National Adivisory Unit on Rare Disorders, The Norwegian Resouce Centre for Cystic Fibrosis, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does oxygen saturation during exercise predict in-flight hypoxemia in adult patients with CF?	Oxygen saturation is measured by pulse oximetry (SpO2) during exercise and HAST	1 day