- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01420224
Study of the Effects of Commercial Air Travel on the Lungs
Study of the Effects of Commercial Air Travel on Pulmonary Artery Pressure in Healthy Passengers and in a Patient With Chuvash Polycythaemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In a commercial airliner flying at high altitude, the reduced cabin air pressure means that all passengers are exposed to slightly lowered oxygen levels ('hypoxia') equivalent to an altitude of approximately 5,000 to 8,000 ft. Although mild, this hypoxia is sufficient to stimulate some of the body's protective responses (eg changes in breathing and in hormonal secretion) and can be dangerous for passengers with heart or lung disease, who must breathe supplementary oxygen in-flight or may even be prohibited from flying because of the risks of hypoxia.
It is well known that severe hypoxia results in constriction of blood vessels in the lungs (a phenomenon called hypoxic pulmonary vasoconstriction), which in turn causes an increase in the blood pressure in the lungs ('pulmonary arterial pressure'). Unlike other physiological responses to hypoxia, this is often harmful and frequently leads to pulmonary hypertension and right heart failure (eg in some lung diseases and at high altitude). Even a modest increase in pulmonary arterial pressure could be clinically important in some airline passengers with heart/lung disease, as it may exacerbate their condition. However, it is not known whether the mild hypoxia experienced in an aircraft cabin is able to cause an increase in pulmonary artery pressure. Limited evidence suggests that it might - for example, there have been reports of passengers acutely developing new right heart failure in-flight, and data from animal studies also support this possibility.
This study aims to establish the effect of mild aircraft cabin hypoxia on pulmonary arterial pressure in healthy passengers and also in a patient with Chuvash polycythaemia. In this rare genetic disease, cellular responses to hypoxia are 'switched on' to some extent even during normoxia, causing increased red blood cell production. Affected individuals usually present with symptoms of polycythaemia in early adulthood and are typically asymptomatic following treatment with therapeutic venesection. Importantly, affected individuals have exaggerated acute hypoxic pulmonary vasoconstriction which may place them at risk of pulmonary hypertensive responses during air travel.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Oxford, United Kingdom, OX13PT
- University of Oxford
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
For healthy volunteers:
Inclusion Criteria:
- suitable for echocardiographic measurements
- in good health
Exclusion Criteria:
- any significant medical condition
For patient with Chuvash polycythaemia:
Inclusion Criteria:
- diagnosis of Chuvash polycythaemia
- suitable for echocardiographic measurements
Exclusion Criteria:
- any other significant medical condition
- pulmonary hypertension
- uncontrolled erythrocytosis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy volunteers
|
Normal scheduled passenger flight
|
Chuvash polycythaemia
|
Normal scheduled passenger flight
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic pulmonary artery pressure
Time Frame: In-flight
|
The primary outcome measure is the effect of commercial air travel on systolic pulmonary artery pressure assessed by in-flight portable Doppler echocardiography.
|
In-flight
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Smith, MBBS DPhil FRCA, University of Oxford
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Oxford in-flight 2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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