COPDNCT02848391
Hypobaric Flight Simulation in COPD Patients
A study testing Environmental in people with COPD and Hypoxia, run by Krankenhaus Kloster Grafschaft at 1 site in Germany.
Trial summary
Aim of this study was to evaluate the hypoxic response during hypobaric flight simulation in normal individuals as well as in normocapnic and hypercapnic COPD patients as well as to evaluate the impact of a flight simulation on walking endurance in these patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Environmental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Sep 2017
- Phase
- Interventional
- 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
Who may be able to join
- No lung disease
- COPD without hypercapnea
- COPD with hypercapnea
Who cannot join
- Claustrophobia
- Renal insufficiency
- Heart failure (ejection fraction < 45 %)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Hypobaric Flight Simulation on Walking Endurance in COPD Patients
Aim of this study was to evaluate the hypoxic response during hypobaric flight simulation in normal individuals as well as in normocapnic and hypercapnic COPD patients as well as to evaluate the impact of a flight simulation on walking endurance in these patients.
Read the detailed description
Background and aim:
Commercial aircrafts have their altitude compensation adjusted to 2500 meter above sea level which corresponds to a pressure difference of about 270 hPa. This causes a reduction of the partial pressure of oxygen during the flight. Patients with lung disease are especially challenged by large walking distances within airports and during their journey. The objective of our study is to evaluate the impact of a simulated flight under hyperbaric conditions on walking endurance in healthy individuals as well as in COPD Patients with and without hypercapnia.
Method:
Healthy individuals as well as COPD patients were assessed pre-flight with the following measurements:
- Arterial blood gas analysis
- Lung function test
- Lung diffusion test
- Hemoglobin level
- Six minute walking distance
During the flight measurements included (measured every 30 minutes until landing):
- Heartrate
- Oxygen saturation
- Borg scale
Post flight measurements included:
- Arterial blood gas analysis
- Six minute walking distance
Intended analysis:
- Description of endurance response as a function of COPD disease severity.
- Description of endurance response in normocapnic and hypercapnic COPD patients.
- Detection of pre-flight predictors that determine flight tolerability and hypoxic response.
- Being tested
- Environmental
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvironmentalOther
hypobaric flight simulation
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Experimental | three hour flight simulation Receives: Other: Environmental |
| COPD normocapnic | Experimental | three hour flight simulation Receives: Other: Environmental |
| COPD hypercapnic | Experimental | three hour flight simulation Receives: Other: Environmental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in six minute walking distance measured in meters
difference between pre- and post-flight walking distance
Measured: 30 Minutes before and after a 3 hour simulated flight (Time point - 30 and + 210 minutes)
Secondary outcomes (1)
minimal Oxygen saturation measured by pulse oxymetry in %
Nadir of the oxygen saturation during the flight
Measured: measurement completed at 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJan 2013
- Primary completionAug 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Kloster Grafschaft
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominic Dellweg, M.D., Krankenhaus Kloster Grafschaft
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848391
- Sponsor's protocol ID
- Airtravel01
- Status last verified
- Feb 2018
- First submitted
- 24 Jun 2016
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hypobaric Flight Simulation on Walking Endurance in COPD Patients
- ClinicalTrials.gov ID
- NCT02848391
- Acronym / sponsor ID
- Airtravel01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Krankenhaus Kloster GrafschaftUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 28 Jul 2016 (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.
Aim of this study was to evaluate the hypoxic response during hypobaric flight simulation in normal individuals as well as in normocapnic and hypercapnic COPD patients as well as to evaluate the impact of a flight simulation on walking endurance in these patients.
Detailed description
Background and aim:
Commercial aircrafts have their altitude compensation adjusted to 2500 meter above sea level which corresponds to a pressure difference of about 270 hPa. This causes a reduction of the partial pressure of oxygen during the flight. Patients with lung disease are especially challenged by large walking distances within airports and during their journey. The objective of our study is to evaluate the impact of a simulated flight under hyperbaric conditions on walking endurance in healthy individuals as well as in COPD Patients with and without hypercapnia.
Method:
Healthy individuals as well as COPD patients were assessed pre-flight with the following measurements:
- Arterial blood gas analysis
- Lung function test
- Lung diffusion test
- Hemoglobin level
- Six minute walking distance
During the flight measurements included (measured every 30 minutes until landing):
- Heartrate
- Oxygen saturation
- Borg scale
Post flight measurements included:
- Arterial blood gas analysis
- Six minute walking distance
Intended analysis:
- Description of endurance response as a function of COPD disease severity.
- Description of endurance response in normocapnic and hypercapnic COPD patients.
- Detection of pre-flight predictors that determine flight tolerability and hypoxic response.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | Experimental | Other: Environmentalthree hour flight simulation |
| COPD normocapnic | Experimental | Other: Environmentalthree hour flight simulation |
| COPD hypercapnic | Experimental | Other: Environmentalthree hour flight simulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No lung disease
- COPD without hypercapnea
- COPD with hypercapnea
Key exclusion criteria (3 listed)
- Claustrophobia
- Renal insufficiency
- Heart failure (ejection fraction < 45 %)
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 |
|---|---|---|
| Environmentalhypobaric flight simulation | Other | COPD hypercapnic, COPD normocapnic, healthy subjects |
Primary outcome
Change in six minute walking distance measured in meters
Time frame: 30 Minutes before and after a 3 hour simulated flight (Time point - 30 and + 210 minutes)
difference between pre- and post-flight walking distance
1 secondary outcome
minimal Oxygen saturation measured by pulse oxymetry in %
Time frame: measurement completed at 180 minutes
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 1 Mar 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental in people with COPD and Hypoxia, run by Krankenhaus Kloster Grafschaft at 1 site in Germany.
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 3 inclusion and 3 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 1 Mar 2018. 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 Germany. 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?
Change in six minute walking distance measured in meters (time frame: 30 Minutes before and after a 3 hour simulated flight (Time point - 30 and + 210 minutes)). 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 1 Mar 2018.