Cystic Fibrosis and Fit-to-Fly (CyFF)

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Cystic Fibrosis; Hypoxemia
• Intervention / Treatment: Other: Pre-flight evaluation

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 Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0407
    • Oslo University Hospital Ullevaal, Department of Pulmonary Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University Hospital, Akershus; The Norwegian Resouce Centre for Cystic Fibrosis; Norwegian National Adivisory Unit on Rare Disorders
• Investigators: Principal Investigator: Aina Akerø, MD PhD, Oslo University Hospital, Dept. of Pulm. Med.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Hypoxemia; Air travel; Pre-flight evaluation; Pulseoximetry; Exercise desaturation; Hypobaria
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Signs and Symptoms, Respiratory; Pancreatic Diseases; Fibrosis; Lung Diseases; Cystic Fibrosis; Hypoxia
• Other Study ID Numbers: 2018/1607 (REK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participants data available to other researchers due to restrictions from Oslo University Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No