Circulatory CollapseNCT00713102
Surgical and Medical Emergencies on Board of European Aircraft Carriers
An observational study of Circulatory Collapse and Chest Pain, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
The goal of this retrospective study is to describe emergency relevant illnesses occurring in airline passengers. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Circulatory Collapse, Chest Pain, Diarrhea
- How many people
- 10,189 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Aug 2008
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men, women, adolescent, children and babies who have suffered from an emergency on board an European airline.
Who may be able to join
- Men, women, adolescent, children and babies who have suffered from an emergency on board an European airline.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany
Bochum, North Rhine-Westphalia, 44791
About this study
The goal of this retrospective study is to describe emergency relevant illnesses occurring in airline passengers.
Read the detailed description
An epidemiologic database documenting medical and surgical emergencies across European airlines will provide access to data potentially valuable for further flight-epidemiological research. Data on medical emergencies / per rpk (revenue passenger kilometres) are sparse and often based on data from a single airline. While handling the data the regulations of the data protection act of the Ethic commission of the Ruhr-University Bochum are fully respected. As noted, evaluation of the data will be completely anonymized without any information regarding the airline or other details than the passengers illness.
Preview: The results of the study specified above will be submitted for publication in a peer review and Medline listed journal.
Study Design: Retrospective, epidemiological study for the evaluation of medical and surgical emergencies on board airliners.
Patients: In the context of a retrospective study approximately 20,000 patient data from 32 European airlines are collected and statistically evaluated.
Documentation: The direct documentation takes place through project responsible person into an electronic statistical data base.
- Conditions
- Circulatory Collapse, Chest Pain, Diarrhea
- Keywords
- in-flight emergency
- Medical subject headings
- Shock, Chest Pain, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | The group includes 10189 patients with on board medical or surgical emergencies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality, cause of medical or surgical emergency while on aircraft
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circulatory CollapseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10,189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sand, Ruhr University of Bochum
- Investigators
- Benno Mann, MD, Study chair, Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University BochumMichael Sand, MD, Principal investigator, Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713102
- Sponsor's protocol ID
- 004
- Status last verified
- Oct 2016
- First submitted
- 8 Jul 2008
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sand M, Bechara FG, Sand D, Mann B. Surgical and medical emergencies on board European aircraft: a retrospective study of 10189 cases. Crit Care. 2009;13(1):R3. doi: 10.1186/cc7690. Epub 2009 Jan 20.
PubMed 19154581
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Medical Emergencies on Board of European Aircraft Carriers
- ClinicalTrials.gov ID
- NCT00713102
- Acronym / sponsor ID
- 004
- Conditions
- Circulatory Collapse, Chest Pain, Diarrhea
- Keywords
- in-flight emergency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,189 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 11 Jul 2008 (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 goal of this retrospective study is to describe emergency relevant illnesses occurring in airline passengers.
Detailed description
An epidemiologic database documenting medical and surgical emergencies across European airlines will provide access to data potentially valuable for further flight-epidemiological research. Data on medical emergencies / per rpk (revenue passenger kilometres) are sparse and often based on data from a single airline. While handling the data the regulations of the data protection act of the Ethic commission of the Ruhr-University Bochum are fully respected. As noted, evaluation of the data will be completely anonymized without any information regarding the airline or other details than the passengers illness.
Preview: The results of the study specified above will be submitted for publication in a peer review and Medline listed journal.
Study Design: Retrospective, epidemiological study for the evaluation of medical and surgical emergencies on board airliners.
Patients: In the context of a retrospective study approximately 20,000 patient data from 32 European airlines are collected and statistically evaluated.
Documentation: The direct documentation takes place through project responsible person into an electronic statistical data base.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –The group includes 10189 patients with on board medical or surgical emergencies. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men, women, adolescent, children and babies who have suffered from an emergency on board an European airline.
Key inclusion criteria (1 listed)
- Men, women, adolescent, children and babies who have suffered from an emergency on board an European airline.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality, cause of medical or surgical emergency while on aircraft
Time frame: 5 years
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 4 Oct 2016.
- Results publication: PubMed 19154581Sand M, Bechara FG, Sand D, Mann B. Surgical and medical emergencies on board European aircraft: a retrospective study of 10189 cases. Crit Care. 2009;13(1):R3. doi: 10.1186/cc7690. Epub 2009 Jan 20.
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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.
Benno Mann, MD study chair
Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum
Michael Sand, MD principal investigator
Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany
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 Circulatory Collapse and Chest Pain, run by Ruhr University of Bochum 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 1 inclusion and 1 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 4 Oct 2016. 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?
All cause mortality, cause of medical or surgical emergency while on aircraft (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00713102, which also lists 1 linked publication.
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 4 Oct 2016.