Alpine AccidentNCT03405467
10-years Nationwide Alpine Accidents in Austria
An observational study of Alpine Accident and Frostbite, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
This observational study intends to analyze the characteristic of specific accidents happened in Austrian's mountainous regions. The mechanisms of accidents which are evaluated are lightning accidents, cardiopulmonary resuscitation with or without automated external defibrillator, frostbite injuries, accidents with… Read more about this study
- Who is it for?
- Ages Up to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Alpine Accident, Frostbite, Cardiopulmonary Arrest With Successful Resuscitation
- What is being tested?
- general and specific data
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- 21 Jan 2015to 31 Aug 2017
- 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 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All Patients in the two databases eligible for the searched injury patterns.
Who may be able to join
- Person suffering the injury searched for;
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Austria1 site
General and Surgical Critical Care Medicine, Medical University of Innsbruck
Innsbruck, 6020
About this study
Official title: A Retrospective 10-years Nationwide Observational Study of Alpine Accidents - Flight Accidents, CPR and AED in Alpine Region, Frostbite Injuries and Lightning Strike
This observational study intends to analyze the characteristic of specific accidents happened in Austrian's mountainous regions. The mechanisms of accidents which are evaluated are lightning accidents, cardiopulmonary resuscitation with or without automated external defibrillator, frostbite injuries, accidents with flying vehicle (e.g. paraglider, hang-glider…).
Read the detailed description
The data are collected retrospectively from the database of Austrian alpine police force. These data are analyzed. The information from this database (scene of accident, weather, daytime…) is compared to secondary data collected from the University Hospital of Innsbruck. The comparison of both databases was approved by the Austrian Data Protection Agency. The goal of the study is to give detailed information of circumstances leading to accident and give medical information of the patient's condition and his outcome.
- Conditions
- Alpine Accident, Frostbite, Cardiopulmonary Arrest With Successful Resuscitation, Lightning Injuries, Flight Accident
- Being tested
- general and specific data
- Medical subject headings
- Frostbite, Lightning Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general and specific dataOther
General and specific data collected
| Study group | Role | What they receive |
|---|---|---|
| lightning accident | patients suffered injuries due to lightning strike Receives: Other: general and specific data | |
| frostbite | patients suffered injuries due to local hypothermia leading to frostbite injuries Receives: Other: general and specific data | |
| cpr and aed | patients suffered cardiac arrest in alpine region treated with or without automated external defibrillatior Receives: Other: general and specific data | |
| flight accident | patients suffered injuries due to use of a flying vehicle in mountainous regions. Receives: Other: general and specific data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of persons suffered an accident in Alpine Mountains in Austria
The number of persons (n/year) which suffered one of the specified accidents.
Measured: 2005-2015
Gender of persons suffered an accident in Alpine Mountains in Austria
Gender male/female or non specified which suffered one of the specified accidents.
Measured: 2005-2015
Mortality of persons suffered an accident in Alpine Mountains in Austria
Number of persons deceased (deceased/n per year) which suffered one of the specified accidents.
Measured: 2005-2015
Secondary outcomes (5)
Number of pattern like injured patients treated in University Hospital of Innsbruck, a major tertiary trauma center in western Austria.
(n/year) treated in University Hospital of Innsbruck
Measured: 2005-2015
Gender of pattern like injured patients treated in University Hospital of Innsbruck, a major tertiary trauma center in western Austria.
male/female, unspecified treated in University Hospital of Innsbruck
Measured: 2005-2015
Injury severity score (ISS) of pattern like injured patients treated in University Hospital of Innsbruck, a major tertiary trauma center in western Austria.
Injury severity score of suffered injury (ISS=AIS*AIS)
Measured: 2005-2015
Abbreviated Injury severity scale (AIS) of pattern like injured patients treated in University Hospital of Innsbruck, a major tertiary trauma center in western Austria.
Abreviated Injury severity scale of suffered injury (1-6 points; scale - minor, moderate, serious, severe, critial, maximum)
Measured: 2005-2015
Type of evacuation and mortality
Type of evacuation (terrestrial, helicopter, combined terrestrial and helicopter) and the mortality for each group (deceased/n per year)
Measured: 2005-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start21 Jan 2015
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
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 Alpine AccidentStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Ströhle, Medical University Innsbruck
- Investigators
- Peter Paal, Dr, Principal investigator, Hospital of Barmherzige Brüder Salzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405467
- Sponsor's protocol ID
- AN4757 315/4.4
- Status last verified
- Jan 2018
- First submitted
- 28 Nov 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strohle M, Wallner B, Lanthaler M, Rauch S, Brugger H, Paal P. Lightning accidents in the Austrian alps - a 10-year retrospective nationwide analysis. Scand J Trauma Resusc Emerg Med. 2018 Sep 10;26(1):74. doi: 10.1186/s13049-018-0543-9.
PubMed 30201016
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective 10-years Nationwide Observational Study of Alpine Accidents - Flight Accidents, CPR and AED in Alpine Region, Frostbite Injuries and Lightning Strike
- ClinicalTrials.gov ID
- NCT03405467
- Acronym / sponsor ID
- AN4757 315/4.4
- Conditions
- Alpine Accident, Frostbite, Cardiopulmonary Arrest With Successful Resuscitation, Lightning Injuries, Flight Accident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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.
This observational study intends to analyze the characteristic of specific accidents happened in Austrian's mountainous regions. The mechanisms of accidents which are evaluated are lightning accidents, cardiopulmonary resuscitation with or without automated external defibrillator, frostbite injuries, accidents with flying vehicle (e.g. paraglider, hang-glider…).
Detailed description
The data are collected retrospectively from the database of Austrian alpine police force. These data are analyzed. The information from this database (scene of accident, weather, daytime…) is compared to secondary data collected from the University Hospital of Innsbruck. The comparison of both databases was approved by the Austrian Data Protection Agency. The goal of the study is to give detailed information of circumstances leading to accident and give medical information of the patient's condition and his outcome.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lightning accident | – | Other: general and specific datapatients suffered injuries due to lightning strike |
| frostbite | – | Other: general and specific datapatients suffered injuries due to local hypothermia leading to frostbite injuries |
| cpr and aed | – | Other: general and specific datapatients suffered cardiac arrest in alpine region treated with or without automated external defibrillatior |
| flight accident | – | Other: general and specific datapatients suffered injuries due to use of a flying vehicle in mountainous regions. |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Patients in the two databases eligible for the searched injury patterns.
Key inclusion criteria (1 listed)
- Person suffering the injury searched for;
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| general and specific dataGeneral and specific data collected | Other | cpr and aed, flight accident, frostbite, lightning accident |
Primary outcome
Number of persons suffered an accident in Alpine Mountains in Austria
Time frame: 2005-2015
The number of persons (n/year) which suffered one of the specified accidents.
Gender of persons suffered an accident in Alpine Mountains in Austria
Time frame: 2005-2015
Gender male/female or non specified which suffered one of the specified accidents.
Mortality of persons suffered an accident in Alpine Mountains in Austria
Time frame: 2005-2015
Number of persons deceased (deceased/n per year) which suffered one of the specified accidents.
5 secondary outcomes
Number of pattern like injured patients treated in University Hospital of Innsbruck, a major tertiary trauma center in western Austria.
Time frame: 2005-2015
Gender of pattern like injured patients treated in University Hospital of Innsbruck, a major tertiary trauma center in western Austria.
Time frame: 2005-2015
Injury severity score (ISS) of pattern like injured patients treated in University Hospital of Innsbruck, a major tertiary trauma center in western Austria.
Time frame: 2005-2015
Abbreviated Injury severity scale (AIS) of pattern like injured patients treated in University Hospital of Innsbruck, a major tertiary trauma center in western Austria.
Time frame: 2005-2015
Type of evacuation and mortality
Time frame: 2005-2015
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 23 Jan 2018.
- Derived from this study: PubMed 30201016Strohle M, Wallner B, Lanthaler M, Rauch S, Brugger H, Paal P. Lightning accidents in the Austrian alps - a 10-year retrospective nationwide analysis. Scand J Trauma Resusc Emerg Med. 2018 Sep 10;26(1):74. doi: 10.1186/s13049-018-0543-9.
- Individual participant dataSharing planned: No
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.
Peter Paal, Dr principal investigator
Hospital of Barmherzige Brüder Salzburg
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 Alpine Accident and Frostbite, run by Medical University Innsbruck at 1 site in Austria.
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 23 Jan 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 Austria. 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?
Number of persons suffered an accident in Alpine Mountains in Austria (time frame: 2005-2015). The study lists 3 primary outcomes in all. 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 NCT03405467, 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 23 Jan 2018.