Wounds and InjuriesNCT01091610
Work Related Injuries Among Prehospital Emergency Medical Staff, an Observational Study
An observational study of Wounds and Injuries and Accidents, Occupational, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
Ambulance personnel often work in a dangerous environment and work related injuries of emergency medical staff have repeatedly been documented. However, only case reports are published and no data exist about the incidence and type of work related injuries of ambulance personnel. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wounds and Injuries, Accidents, Occupational
- How many people
- 0 participants
- Where
- 2 sitesSwitzerland
- Study dates
- May 2010to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all ambulance companies in Switzerland (including air, ground and water associated) will be contacted to provide data of their personnel of the past 10 years. All accidents leading to leave from work will be analyzed according to parameters concerning the ambulance organisation, the person and the emergency mission. In addition, data of additionally injured non-medical persons due to an emergency mission will be analyzed.
Who may be able to join
- human
- leave from work
- work related mortality
- work related injury
- needle stick injury
- psychological distress
Show all 10Show fewer
- innocent bystander
- unintentional injury
- intentional injury
- emergency mission
Who cannot join
- medical reason
- chronic illness
- non-work related injury
- non-work related mortality
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
department of anaesthesiology and pain medicine, Bern University Hospital, Bern,
Bern, Canton of Bern, 3010
SSUV Sammelstelle für die Statistik der Unfallversicherungen
Lucerne, Canton of Lucerne, 4358
About this study
Official title: Work Related Injuries Among Prehospital Emergency Medical Staff, a Retrospective, Observational Study
Ambulance personnel often work in a dangerous environment and work related injuries of emergency medical staff have repeatedly been documented. However, only case reports are published and no data exist about the incidence and type of work related injuries of ambulance personnel.
Aims:
The primary aim of the study is to assess the incidence (number of new injuries per 100'000 emergency missions or per 1'000 flying hours) and type of work related injuries among prehospital emergency personal. The secondary aims are to identify risk factors associated with work related injuries and to compare the risk of injury to other groups of professionals such as hospital nurses, policemen or fire-fighters.
Read the detailed description
Background
Background:
Staff of emergency medical missions is at high risk of work-related injuries. Over 8 % of emergency medical staff have been reported to be victims of work-related injuries, leading to a time away from work of 9.4 %. Others have reported a rate of 5 - 25 accidents per 100'000 flight hours or 55 per 100'000 road ambulance transports. A ten year retrospective analysis of US public roadways identified 331 accidents with 405 fatalities and 838 injuries. Speed of work, unknown work surroundings, difficult working conditions such as poor lighting and tight work environment may all contribute to injuries. While mishaps and unintentional injuries cause most incidents, frank assaults pose additional threats to medical staff. In the US the injury rate for EMS workers are higher than rates reported by the department of labour for any other industry. Most commonly reported injuries include strains and sprains, however, permanent disabilities and fatal injuries have been reported. Even though the medical profession's first duty is to do no harm, innocent bystanders have repeatedly been victims of ambulance crashes. In fact, one study reported a greater burden of injury on persons not in the ambulance. While emergency medical work pose some intrinsic risks to patients and workers, several risk factors have been identified which are associated with increased risk of incapacitating or fatal injuries, e.g., positioning in the rear of an ambulance or improper restrains, younger EMS professionals and sleeping problems and while on non-emergency travels. Inadequate restrains pose a particular risk in paediatric emergency transport.
No data for work-related injuries have been reported for prehospital medical crew in Europe.
Aims:
The primary aim of the study is to assess the incidence (number of new injuries per 100'000 emergency missions or per 1'000 flying hours) and type of work related injuries among prehospital emergency personal. The secondary aims are to identify risk factors associated with work related injuries and to compare the risk of injury to other groups of professionals such as hospital nurses, policemen or fire-fighters.
Setting:
Prehospital emergency medical services (EMS) in Switzerland, including ground, air and water-related ambulance services. All certified ambulance services for air, traffic and water accidents are eligible for participation and will be contacted and invited to participate. Additional supporting rescue companies such as rescue squad of the Swiss Alpine Club or of a ski resort as well as lay rescuers will not be included in the analysis. All accidents on medical missions of a prolonged period are analysed. Depending on the available data in the different ambulance services, the study period may extend from at least one year up to a maximum of 10 years.
Methods:
Incidents are defined as:
- an unintentional (i.e. accident) or intentional (i.e. assault) injury during an emergency medical mission leading to leave from work, including:
- EMS personal,
- innocent bystanders or
- additional injuries to patients transported;
- a needle stick injury, even if it will not lead to a leave from work;
- a leave from work due to a severe psychological distress during an emergency mission, e.g. death of a child
Medical reasons (e.g. common flu, chronic back pain) resulting in leave from work are not considered as incidents and will not be included.
Severity of injury will be stratified according to the KABCO classification as suggested previously (K: killed, A: incapacitating injury, B: non-incapacitating injury, C: possible injury, O: no apparent injury).
Incidents will be analysed according to parameters related to an ambulance organisation, type of emergency mission and injuries to patients, EMS personal and innocent bystanders. Since the prevalence of accidents or near misses is expected to be low, a large number of emergency missions of a large time span must be investigated. To allow a timely analysis, data will be gathered retrospectively. The data of the victims (cases, i.e. ambulance worker) will be collected anonymously. Cases will be identified using the accident number (Schadennummer) and the UVG (Unfallversicherungsgesetz) insurer. Personal data will thus be anonymous at the study centre in Bern.
Data evaluation and statistics:
In a first step the total incidence of work-related injuries (number of new injuries divided by number of missions or divided by number of flying hours) will be determined as primary endpoint among street, air and sea ambulance services in Switzerland. Descriptive statistics will be used.
Risk factors, i.e. secondary endpoints, will be analyzed using univariable and multivariable multilevel linear regression models with three levels: 1. ambulance organization, 2. ambulance mission and 3. victim. Possible risk factors may include for:
- ambulance organization:
- type of ambulance organization, (ground, air, sea)
- geographical region of the ambulance organization (German, French, Italian-romansch speaking region of Switzerland)
- rural - urban setting
- hospital association of ambulance service
- number of collaborators at ambulance service
- number of missions per year
- mission:
- time of day
- weekday
- time of year
- weather conditions
- duration of mission
- type of accident (unintentional accident, assault, psychological "injury")
- phase of mission (during approach, on site of accident, on way to hospital, during hand-over / on hospital ground, on way home)
- type of mission (primary mission, i.e. direct approach to accident, secondary mission (interhospital transfer).
- with / without special signal, i.e. signal and lights
- Victim associated:
- Age at the time of accident
- gender
- years of on the job experience
- role during the accident-related rescue mission (driver, paramedic, pilot,…), position at time of accident (driver compartment, patient compartment,…)
- part-time, fulltime employment
- number of mission per collaborator and per year
- patient characteristics (patient to be transported suffered additional injury, patient escort e.g. parent of child-patient, member of rescue team, bystander)
- degree of injury (deceased, permanent injury, non-permanent injury, possible injury, uninjured)
- duration of leave from work
- position at the time of accident (driver compartment, patient compartment, outside vehicle, in / on other vehicle)
- innocent bystander
- patient to be transported
In a second step the comparison with other professional groups, e.g. hospital nurses, policemen or fire-fighters will be performed. The data of the first step will allow to perform a sample size calculation for future research.
Objective
Aims:
The primary aim of the study is to assess the incidence (number of new injuries per 100'000 emergency missions or per 1'000 flying hours) and type of work related injuries among prehospital emergency personal. The secondary aims are to identify risk factors associated with work related injuries and to compare the risk of injury to other groups of professionals such as hospital nurses, policemen or fire-fighters.
Methods
Prehospital emergency medical services (EMS) in Switzerland. All certified ambulance services for air, traffic and water accidents are eligible for participation and will be contacted and invited to participate. All accidents on medical missions of a prolonged period are analysed.
Incidents are defined as:
- an unintentional (i.e. accident) or intentional (i.e. assault) injury during an emergency medical mission leading to leave from work, including:
- EMS personal,
- innocent bystanders or
- additional injuries to patients transported;
- a needle stick injury, even if it will not lead to a leave from work;
- a leave from work due to a severe psychological distress during an emergency mission
- Conditions
- Wounds and Injuries, Accidents, Occupational
- Being tested
- no intervention
- Keywords
- retrospective study, wounds and injuries/epidemiology, emergency medical technicians, human, emergency medical services, ambulance, health personnel, emergency medicine, risk factors
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
purely observational retrospective study. no interventions are planned.
| Study group | Role | What they receive |
|---|---|---|
| 1 | all emergency medical staff having suffered an accident during work Receives: Other: no intervention | |
| 2 | non emergency medical personnel having suffered an injury due to a medical mission, e.g. transported patient having suffered additional injury due to an ambulance accident or collision of an ambulance with another vehicle. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall incidence of injuries and mortality
Measured: 10 years
Secondary outcomes (2)
risk factors for injuries
Measured: 10 years
incidence of additional injuries to others
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMay 2010
Why it stopped: no collaboration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Sammelstelle der Statistik der Unfallversicherungen (SSUV), Luzern
- Investigators
- Kay H Stricker, MD, Study chair, Department of anaesthesiology and pain medicine, Bern University HospitalMartin Luginbühl, MD, Study director, Department of anaesthesiology and pain medicine, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091610
- Sponsor's protocol ID
- KEK21-01-10
- Status last verified
- Mar 2011
- First submitted
- 21 Mar 2010
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Maguire BJ, Hunting KL, Smith GS, Levick NR. Occupational fatalities in emergency medical services: a hidden crisis. Ann Emerg Med. 2002 Dec;40(6):625-32. doi: 10.1067/mem.2002.128681.
PubMed 12447340Maguire BJ, Hunting KL, Guidotti TL, Smith GS. Occupational injuries among emergency medical services personnel. Prehosp Emerg Care. 2005 Oct-Dec;9(4):405-11. doi: 10.1080/10903120500255065.
PubMed 16263673Studnek JR, Ferketich A, Crawford JM. On the job illness and injury resulting in lost work time among a national cohort of emergency medical services professionals. Am J Ind Med. 2007 Dec;50(12):921-31. doi: 10.1002/ajim.20516.
PubMed 17918231Flabouris A, Runciman WB, Levings B. Incidents during out-of-hospital patient transportation. Anaesth Intensive Care. 2006 Apr;34(2):228-36. doi: 10.1177/0310057X0603400216.
PubMed 16617646Kahn CA, Pirrallo RG, Kuhn EM. Characteristics of fatal ambulance crashes in the United States: an 11-year retrospective analysis. Prehosp Emerg Care. 2001 Jul-Sep;5(3):261-9. doi: 10.1080/10903120190939751.
PubMed 11446540Greene J. Rising helicopter crash deaths spur debate over proper use of air transport. Ann Emerg Med. 2009 Mar;53(3):15A-17A. doi: 10.1016/j.annemergmed.2009.01.007. No abstract available.
PubMed 19244622Johnson TD, Lindholm D, Dowd MD. Child and provider restraints in ambulances: knowledge, opinions, and behaviors of emergency medical services providers. Acad Emerg Med. 2006 Aug;13(8):886-92. doi: 10.1197/j.aem.2006.03.562. Epub 2006 Jul 6.
PubMed 16825667Becker LR, Zaloshnja E, Levick N, Li G, Miller TR. Relative risk of injury and death in ambulances and other emergency vehicles. Accid Anal Prev. 2003 Nov;35(6):941-8. doi: 10.1016/s0001-4575(02)00102-1.
PubMed 12971929
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work Related Injuries Among Prehospital Emergency Medical Staff, a Retrospective, Observational Study
- ClinicalTrials.gov ID
- NCT01091610
- Acronym / sponsor ID
- KEK21-01-10
- Conditions
- Wounds and Injuries, Accidents, Occupational
- Keywords
- retrospective study, wounds and injuries/epidemiology, emergency medical technicians, human, emergency medical services, ambulance, health personnel, emergency medicine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no collaboration
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Sammelstelle der Statistik der Unfallversicherungen (SSUV), Luzern
- Study start
- May 2010
- First posted
- 24 Mar 2010 (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.
Ambulance personnel often work in a dangerous environment and work related injuries of emergency medical staff have repeatedly been documented. However, only case reports are published and no data exist about the incidence and type of work related injuries of ambulance personnel.
Aims:
The primary aim of the study is to assess the incidence (number of new injuries per 100'000 emergency missions or per 1'000 flying hours) and type of work related injuries among prehospital emergency personal. The secondary aims are to identify risk factors associated with work related injuries and to compare the risk of injury to other groups of professionals such as hospital nurses, policemen or fire-fighters.
Detailed description
Background
Background:
Staff of emergency medical missions is at high risk of work-related injuries. Over 8 % of emergency medical staff have been reported to be victims of work-related injuries, leading to a time away from work of 9.4 %. Others have reported a rate of 5 - 25 accidents per 100'000 flight hours or 55 per 100'000 road ambulance transports. A ten year retrospective analysis of US public roadways identified 331 accidents with 405 fatalities and 838 injuries. Speed of work, unknown work surroundings, difficult working conditions such as poor lighting and tight work environment may all contribute to injuries. While mishaps and unintentional injuries cause most incidents, frank assaults pose additional threats to medical staff. In the US the injury rate for EMS workers are higher than rates reported by the department of labour for any other industry. Most commonly reported injuries include strains and sprains, however, permanent disabilities and fatal injuries have been reported. Even though the medical profession's first duty is to do no harm, innocent bystanders have repeatedly been victims of ambulance crashes. In fact, one study reported a greater burden of injury on persons not in the ambulance. While emergency medical work pose some intrinsic risks to patients and workers, several risk factors have been identified which are associated with increased risk of incapacitating or fatal injuries, e.g., positioning in the rear of an ambulance or improper restrains, younger EMS professionals and sleeping problems and while on non-emergency travels. Inadequate restrains pose a particular risk in paediatric emergency transport.
No data for work-related injuries have been reported for prehospital medical crew in Europe.
Aims:
The primary aim of the study is to assess the incidence (number of new injuries per 100'000 emergency missions or per 1'000 flying hours) and type of work related injuries among prehospital emergency personal. The secondary aims are to identify risk factors associated with work related injuries and to compare the risk of injury to other groups of professionals such as hospital nurses, policemen or fire-fighters.
Setting:
Prehospital emergency medical services (EMS) in Switzerland, including ground, air and water-related ambulance services. All certified ambulance services for air, traffic and water accidents are eligible for participation and will be contacted and invited to participate. Additional supporting rescue companies such as rescue squad of the Swiss Alpine Club or of a ski resort as well as lay rescuers will not be included in the analysis. All accidents on medical missions of a prolonged period are analysed. Depending on the available data in the different ambulance services, the study period may extend from at least one year up to a maximum of 10 years.
Methods:
Incidents are defined as:
- an unintentional (i.e. accident) or intentional (i.e. assault) injury during an emergency medical mission leading to leave from work, including:
- EMS personal,
- innocent bystanders or
- additional injuries to patients transported;
- a needle stick injury, even if it will not lead to a leave from work;
- a leave from work due to a severe psychological distress during an emergency mission, e.g. death of a child
Medical reasons (e.g. common flu, chronic back pain) resulting in leave from work are not considered as incidents and will not be included.
Severity of injury will be stratified according to the KABCO classification as suggested previously (K: killed, A: incapacitating injury, B: non-incapacitating injury, C: possible injury, O: no apparent injury).
Incidents will be analysed according to parameters related to an ambulance organisation, type of emergency mission and injuries to patients, EMS personal and innocent bystanders. Since the prevalence of accidents or near misses is expected to be low, a large number of emergency missions of a large time span must be investigated. To allow a timely analysis, data will be gathered retrospectively. The data of the victims (cases, i.e. ambulance worker) will be collected anonymously. Cases will be identified using the accident number (Schadennummer) and the UVG (Unfallversicherungsgesetz) insurer. Personal data will thus be anonymous at the study centre in Bern.
Data evaluation and statistics:
In a first step the total incidence of work-related injuries (number of new injuries divided by number of missions or divided by number of flying hours) will be determined as primary endpoint among street, air and sea ambulance services in Switzerland. Descriptive statistics will be used.
Risk factors, i.e. secondary endpoints, will be analyzed using univariable and multivariable multilevel linear regression models with three levels: 1. ambulance organization, 2. ambulance mission and 3. victim. Possible risk factors may include for:
- ambulance organization:
- type of ambulance organization, (ground, air, sea)
- geographical region of the ambulance organization (German, French, Italian-romansch speaking region of Switzerland)
- rural - urban setting
- hospital association of ambulance service
- number of collaborators at ambulance service
- number of missions per year
- mission:
- time of day
- weekday
- time of year
- weather conditions
- duration of mission
- type of accident (unintentional accident, assault, psychological "injury")
- phase of mission (during approach, on site of accident, on way to hospital, during hand-over / on hospital ground, on way home)
- type of mission (primary mission, i.e. direct approach to accident, secondary mission (interhospital transfer).
- with / without special signal, i.e. signal and lights
- Victim associated:
- Age at the time of accident
- gender
- years of on the job experience
- role during the accident-related rescue mission (driver, paramedic, pilot,…), position at time of accident (driver compartment, patient compartment,…)
- part-time, fulltime employment
- number of mission per collaborator and per year
- patient characteristics (patient to be transported suffered additional injury, patient escort e.g. parent of child-patient, member of rescue team, bystander)
- degree of injury (deceased, permanent injury, non-permanent injury, possible injury, uninjured)
- duration of leave from work
- position at the time of accident (driver compartment, patient compartment, outside vehicle, in / on other vehicle)
- innocent bystander
- patient to be transported
In a second step the comparison with other professional groups, e.g. hospital nurses, policemen or fire-fighters will be performed. The data of the first step will allow to perform a sample size calculation for future research.
Objective
Aims:
The primary aim of the study is to assess the incidence (number of new injuries per 100'000 emergency missions or per 1'000 flying hours) and type of work related injuries among prehospital emergency personal. The secondary aims are to identify risk factors associated with work related injuries and to compare the risk of injury to other groups of professionals such as hospital nurses, policemen or fire-fighters.
Methods
Prehospital emergency medical services (EMS) in Switzerland. All certified ambulance services for air, traffic and water accidents are eligible for participation and will be contacted and invited to participate. All accidents on medical missions of a prolonged period are analysed.
Incidents are defined as:
- an unintentional (i.e. accident) or intentional (i.e. assault) injury during an emergency medical mission leading to leave from work, including:
- EMS personal,
- innocent bystanders or
- additional injuries to patients transported;
- a needle stick injury, even if it will not lead to a leave from work;
- a leave from work due to a severe psychological distress during an emergency mission
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: no interventionall emergency medical staff having suffered an accident during work |
| 2 | – | Other: no interventionnon emergency medical personnel having suffered an injury due to a medical mission, e.g. transported patient having suffered additional injury due to an ambulance accident or collision of an ambulance with another vehicle. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all ambulance companies in Switzerland (including air, ground and water associated) will be contacted to provide data of their personnel of the past 10 years. All accidents leading to leave from work will be analyzed according to parameters concerning the ambulance organisation, the person and the emergency mission. In addition, data of additionally injured non-medical persons due to an emergency mission will be analyzed.
Key inclusion criteria (10 listed)
- human
- leave from work
- work related mortality
- work related injury
- needle stick injury
Key exclusion criteria (4 listed)
- medical reason
- chronic illness
- non-work related injury
- non-work related mortality
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 |
|---|---|---|
| no interventionpurely observational retrospective study. no interventions are planned. | Other | 1, 2 |
Primary outcome
overall incidence of injuries and mortality
Time frame: 10 years
2 secondary outcomes
risk factors for injuries
Time frame: 10 years
incidence of additional injuries to others
Time frame: 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
- Background: PubMed 12447340Maguire BJ, Hunting KL, Smith GS, Levick NR. Occupational fatalities in emergency medical services: a hidden crisis. Ann Emerg Med. 2002 Dec;40(6):625-32. doi: 10.1067/mem.2002.128681.
- Background: PubMed 16263673Maguire BJ, Hunting KL, Guidotti TL, Smith GS. Occupational injuries among emergency medical services personnel. Prehosp Emerg Care. 2005 Oct-Dec;9(4):405-11. doi: 10.1080/10903120500255065.
- Background: PubMed 17918231Studnek JR, Ferketich A, Crawford JM. On the job illness and injury resulting in lost work time among a national cohort of emergency medical services professionals. Am J Ind Med. 2007 Dec;50(12):921-31. doi: 10.1002/ajim.20516.
- Background: PubMed 16617646Flabouris A, Runciman WB, Levings B. Incidents during out-of-hospital patient transportation. Anaesth Intensive Care. 2006 Apr;34(2):228-36. doi: 10.1177/0310057X0603400216.
- Background: PubMed 11446540Kahn CA, Pirrallo RG, Kuhn EM. Characteristics of fatal ambulance crashes in the United States: an 11-year retrospective analysis. Prehosp Emerg Care. 2001 Jul-Sep;5(3):261-9. doi: 10.1080/10903120190939751.
- Background: PubMed 19244622Greene J. Rising helicopter crash deaths spur debate over proper use of air transport. Ann Emerg Med. 2009 Mar;53(3):15A-17A. doi: 10.1016/j.annemergmed.2009.01.007. No abstract available.
- Background: PubMed 16825667Johnson TD, Lindholm D, Dowd MD. Child and provider restraints in ambulances: knowledge, opinions, and behaviors of emergency medical services providers. Acad Emerg Med. 2006 Aug;13(8):886-92. doi: 10.1197/j.aem.2006.03.562. Epub 2006 Jul 6.
- Background: PubMed 12971929Becker LR, Zaloshnja E, Levick N, Li G, Miller TR. Relative risk of injury and death in ambulances and other emergency vehicles. Accid Anal Prev. 2003 Nov;35(6):941-8. doi: 10.1016/s0001-4575(02)00102-1.
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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.
Kay H Stricker, MD study chair
Department of anaesthesiology and pain medicine, Bern University Hospital
Martin Luginbühl, MD study director
Department of anaesthesiology and pain medicine, Bern University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries and Accidents, Occupational, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 10 inclusion and 4 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: withdrawn, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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 was withdrawn before enrolling participants, so there are no results.
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?
overall incidence of injuries and mortality (time frame: 10 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 NCT01091610, which also lists 8 linked publications.
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 10 Jul 2015.