Clinical trial NCT03843723: Cystic Fibrosis and Fit-to-Fly
Official title: Exercise Pulse Oximetry and Pre-flight Evaluation of Adult Cystic Fibrosis (CF) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Hypoxemia
Lung Diseases
Keywords: Pre-flight evaluation
Air travel
Pulseoximetry
Exercise desaturation
Hypobaria
Hypoxemia
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Norwegian Resouce Centre for Cystic Fibrosis
name: Norwegian National Adivisory Unit on Rare Disorders
name: University Hospital, Akershus
First posted: 2019-02-18
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Does oxygen saturation during exercise predict in-flight hypoxemia in adult patients with CF?
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital Ullevaal, Department of Pulmonary Medicine
Study officials:
affiliation: Oslo University Hospital, Dept. of Pulm. Med.
name: Aina Akerø, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.