Healthy VolunteersNCT01420224
Study of the Effects of Commercial Air Travel on the Lungs
An observational study of Healthy Volunteers and Chuvash Polycythaemia, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The study hypothesis is that commercial air travel causes an increase in the blood pressure in the lungs (pulmonary artery pressure) that can be clinically relevant. Portable echocardiography (heart ultrasound) now offers a non-invasive means of studying this in-flight. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Chuvash Polycythaemia
- What is being tested?
- Commercial airline flight
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with Chuvash polycythaemia recruited from previous study participants with the disease.
Who may be able to join
- suitable for echocardiographic measurements
- in good health
- diagnosis of Chuvash polycythaemia
- suitable for echocardiographic measurements
Who cannot join
- any significant medical condition
- For patient with Chuvash polycythaemia:
- any other significant medical condition
- pulmonary hypertension
- uncontrolled erythrocytosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effects of Commercial Air Travel on Pulmonary Artery Pressure in Healthy Passengers and in a Patient With Chuvash Polycythaemia
The study hypothesis is that commercial air travel causes an increase in the blood pressure in the lungs (pulmonary artery pressure) that can be clinically relevant. Portable echocardiography (heart ultrasound) now offers a non-invasive means of studying this in-flight.
Read the 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.
- Conditions
- Healthy Volunteers, Chuvash Polycythaemia
- Being tested
- Commercial airline flight
- Keywords
- Air travel, Aircraft cabin hypoxia, Pulmonary artery pressure, Hypoxic pulmonary vasoconstriction, Pulmonary hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial airline flightOther
Normal scheduled passenger flight
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described Receives: Other: Commercial airline flight | |
| Chuvash polycythaemia | Not described Receives: Other: Commercial airline flight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic pulmonary artery pressure
The primary outcome measure is the effect of commercial air travel on systolic pulmonary artery pressure assessed by in-flight portable Doppler echocardiography.
Measured: In-flight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Smith, MBBS DPhil FRCA, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420224
- Sponsor's protocol ID
- Oxford in-flight 2011
- Status last verified
- Aug 2011
- First submitted
- 18 Aug 2011
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Commercial Air Travel on Pulmonary Artery Pressure in Healthy Passengers and in a Patient With Chuvash Polycythaemia
- ClinicalTrials.gov ID
- NCT01420224
- Acronym / sponsor ID
- Oxford in-flight 2011
- Conditions
- Healthy Volunteers, Chuvash Polycythaemia
- Keywords
- Air travel, Aircraft cabin hypoxia, Pulmonary artery pressure, Hypoxic pulmonary vasoconstriction, Pulmonary hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study hypothesis is that commercial air travel causes an increase in the blood pressure in the lungs (pulmonary artery pressure) that can be clinically relevant. Portable echocardiography (heart ultrasound) now offers a non-invasive means of studying this in-flight.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: Commercial airline flight |
| Chuvash polycythaemia | – | Other: Commercial airline flight |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Chuvash polycythaemia recruited from previous study participants with the disease.
Key inclusion criteria (4 listed)
- suitable for echocardiographic measurements
- in good health
- diagnosis of Chuvash polycythaemia
- suitable for echocardiographic measurements
Key exclusion criteria (5 listed)
- any significant medical condition
- any other significant medical condition
- pulmonary hypertension
- uncontrolled erythrocytosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercial airline flightNormal scheduled passenger flight | Other | Chuvash polycythaemia, Healthy volunteers |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Smith, MBBS DPhil FRCA principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Chuvash Polycythaemia, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic pulmonary artery pressure (time frame: In-flight). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2011.