Cystic Fibrosis and Fit-to-Fly

NCT03843723 | Completed

• 1 other identifier: 2018/1607 (REK)
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Hypoxemia; Lung Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with CF evaluated at the Norwegian Resource Centre for Cystic Fibrosis at the Dep. of Pulm. Med. Oslo University Hospital

You may qualify if:

• Adult CF patients (age from 18 years)
• Signed informed consent

You may not qualify if:

• Ongoing exacerbation
• Unable to fulfill a CPET or 6MWT
• Long-term oxygen treatment (LTOT)
• Severe heart disease
• Language problems that interfere with data collection

Sponsors & Collaborators

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

Study Sites (1)

Oslo University Hospital Ullevaal, Department of Pulmonary Medicine

Oslo, 0407, Norway

Location

Related Publications (3)

• 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.

  PMID: 22767877 BACKGROUND

• 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.

  PMID: 21856702 BACKGROUND

• Akero A, Edvardsen E, Finstad PL, Skrede B, Osterhaug M, Backman S, Edvardsen A, Skjonsberg OH. Air travel and cystic fibrosis: An algorithm to assess the risk of In-Flight Hypoxemia. J Cyst Fibros. 2025 Sep;24(5):963-969. doi: 10.1016/j.jcf.2025.05.004. Epub 2025 Jun 3.

  PMID: 40467430 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Hypoxia; Lung Diseases

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aina Akerø, MD PhD

  Oslo University Hospital, Dept. of Pulm. Med.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD PhD

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 18, 2019
• Study Start: March 1, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)