Traffic AccidentsNCT01603537
The Impact of Prehospital Trauma Life Support (PHTLS) on Outcome of Traffic Injury
An observational study of Traffic Accidents, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
Trauma is the leading cause of death among persons below 60 years of age. It is a well-established belief that optimal treatment in the early phase after trauma has a major impact on mortality, and the implementation of specific educational programs for trauma care have been a widely adopted strategy aimed at… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traffic Accidents
- How many people
- 40,000 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to Sep 2012
- 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: Study Population: Motor vehicle traffic crashes were selected using the causes of injury matrix developed by the National Center for Health Statistics, Centers for Disease Control and Prevention, USA.
Who may be able to join
- Primary incident hospital admissions due to traffic accidents or
- Death due to traffic accidents
Who cannot join
- If a patient appears more than once, all but the first event will be excluded from the dataset.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Prehospital Trauma Life Support (PHTLS) Training of Ambulance Caregivers on Outcome of Traffic Injury Victims
Trauma is the leading cause of death among persons below 60 years of age. It is a well-established belief that optimal treatment in the early phase after trauma has a major impact on mortality, and the implementation of specific educational programs for trauma care have been a widely adopted strategy aimed at improving the outcome. This strategy has high face validity, but the underlying evidence is poor. The Prehospital Trauma Life Support (PHTLS) program was introduced in 1983 aiming to integrate prehospital trauma care with the Advanced Trauma Life Support (ATLS) program. Approximately half a million prehospital caregivers in over 50 countries have taken the PHTLS course. It has been recognized as one of the leading educational programs for prehospital emergency trauma care. However, the scientific support for improved patient outcome from courses such as PHTLS and ATLS is limited. According to a Cochrane analysis published 2010 there is no evidence to recommend advanced life-support (ALS) training for ambulance crews. Another Cochrane analysis concerning ATLS gave similar results and a recent study indicated even worsened outcome after the implementation of ATLS. An observational study in the county of Uppsala indicated reduced mortality after the implementation of PHTLS but the estimate was uncertain due to a low overall mortality. The aim of this study is to further investigate the association between PHTLS training of ambulance crew members and the outcome in trauma patients in a larger study population. To accomplish this the investigators will use an epidemiological semi-individual design applied to all victims of traffic injury that occurred during the implementation period of the PHTLS course in Sweden (1998-2004). Four outcomes and subsets of patients will be analyzed: Mortality before hospital admission, mortality within 30 days, time to death among survivors to hospital admission and return to work among survivors to hospital discharge.
Read the detailed description
Source Population: Sweden is divided in 21 administrative regions providing health care (counties). In 2004 Sweden had a population of about 9 million inhabitants with an average population density of 20 inhabitants/km2.
The Emergency Medical Service (EMS)-System: The ambulance staff in Sweden consists of registered nurses and emergency medical technician (EMT) equivalents (nursing assistants with special ambulance training).
Statistics: Hierarchical random effects models will be used to model the binary outcomes. Cox proportional hazards models to analyze the time to event outcomes. The difference in mean predicted outcome between the PHTLS group and the non-PHTLS group will be used to estimate the absolute risk reduction.
- Conditions
- Traffic Accidents
- Keywords
- Traumatic injuries, Prehospital Trauma Life Support, Traffic accidents
- 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.
| Study group | Role | What they receive |
|---|---|---|
| PHTLS | The exposure is defined from the dichotomization of the probability in each event/accident that at least one of the caring ambulance crew members was PHTLS certified. | |
| No PHTLS | Not exposed to PHTLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality before hospital admission.
Injury deaths not associated with a hospital admission.
Measured: Patients will be followed up to death or at least one year after inclusion.
Mortality within 30 days.
Deaths within 30 days including all deaths, prehospital and hospital, up to 30 days from the injury event.
Measured: Patients will be followed up to death or at least one year after inclusion.
Time to death among survivors to hospital admission.
Time to death among patients associated with a hospital admission.
Measured: Patients will be followed up to death or at least one year after inclusion.
Return to work among survivors to hospital discharge.
Number of patients returned to work per time-unit of observation after the injury event among all patients discharged from hospital, not dead, and that was working before the accident.
Measured: Patients will be followed up to occured event or at least one year after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2012 (estimated)
- Study completionSep 2012 (estimated)
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 Traffic AccidentsStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Principal investigator, Hans Blomberg, Uppsala University Hospital
- Investigators
- Rolf Gedeborg, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603537
- Sponsor's protocol ID
- Dnr 2007/264
- Status last verified
- May 2012
- First submitted
- 15 May 2012
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Krug EG, Sharma GK, Lozano R. The global burden of injuries. Am J Public Health. 2000 Apr;90(4):523-6. doi: 10.2105/ajph.90.4.523.
PubMed 10754963Trunkey DD, Lim RC Jr, Blaisdell FW. Traumatic injury. A health care crisis. West J Med. 1974 Jan;120(1):92-4. No abstract available.
PubMed 4812216Collicott PE, Hughes I. Training in advanced trauma life support. JAMA. 1980 Mar 21;243(11):1156-9.
PubMed 7359667Jayaraman S, Sethi D. Advanced trauma life support training for ambulance crews. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003109. doi: 10.1002/14651858.CD003109.pub2.
PubMed 20091538Jayaraman S, Sethi D. Advanced trauma life support training for hospital staff. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004173. doi: 10.1002/14651858.CD004173.pub3.
PubMed 19370594Drimousis PG, Theodorou D, Toutouzas K, Stergiopoulos S, Delicha EM, Giannopoulos P, Larentzakis A, Katsaragakis S. Advanced Trauma Life Support certified physicians in a non trauma system setting: is it enough? Resuscitation. 2011 Feb;82(2):180-4. doi: 10.1016/j.resuscitation.2010.10.005. Epub 2010 Nov 30.
PubMed 21122975Johansson J, Blomberg H, Svennblad B, Wernroth L, Melhus H, Byberg L, Michaelsson K, Karlsten R, Gedeborg R. Prehospital Trauma Life Support (PHTLS) training of ambulance caregivers and impact on survival of trauma victims. Resuscitation. 2012 Oct;83(10):1259-64. doi: 10.1016/j.resuscitation.2012.02.018. Epub 2012 Feb 23.
PubMed 22366502Recommended framework for presenting injury mortality data. MMWR Recomm Rep. 1997 Aug 29;46(RR-14):1-30.
PubMed 9301976
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prehospital Trauma Life Support (PHTLS) Training of Ambulance Caregivers on Outcome of Traffic Injury Victims
- ClinicalTrials.gov ID
- NCT01603537
- Acronym / sponsor ID
- Dnr 2007/264
- Conditions
- Traffic Accidents
- Keywords
- Traumatic injuries, Prehospital Trauma Life Support, Traffic accidents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- Jan 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 23 May 2012 (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.
Trauma is the leading cause of death among persons below 60 years of age. It is a well-established belief that optimal treatment in the early phase after trauma has a major impact on mortality, and the implementation of specific educational programs for trauma care have been a widely adopted strategy aimed at improving the outcome. This strategy has high face validity, but the underlying evidence is poor. The Prehospital Trauma Life Support (PHTLS) program was introduced in 1983 aiming to integrate prehospital trauma care with the Advanced Trauma Life Support (ATLS) program. Approximately half a million prehospital caregivers in over 50 countries have taken the PHTLS course. It has been recognized as one of the leading educational programs for prehospital emergency trauma care. However, the scientific support for improved patient outcome from courses such as PHTLS and ATLS is limited. According to a Cochrane analysis published 2010 there is no evidence to recommend advanced life-support (ALS) training for ambulance crews. Another Cochrane analysis concerning ATLS gave similar results and a recent study indicated even worsened outcome after the implementation of ATLS. An observational study in the county of Uppsala indicated reduced mortality after the implementation of PHTLS but the estimate was uncertain due to a low overall mortality. The aim of this study is to further investigate the association between PHTLS training of ambulance crew members and the outcome in trauma patients in a larger study population. To accomplish this the investigators will use an epidemiological semi-individual design applied to all victims of traffic injury that occurred during the implementation period of the PHTLS course in Sweden (1998-2004). Four outcomes and subsets of patients will be analyzed: Mortality before hospital admission, mortality within 30 days, time to death among survivors to hospital admission and return to work among survivors to hospital discharge.
Detailed description
Source Population: Sweden is divided in 21 administrative regions providing health care (counties). In 2004 Sweden had a population of about 9 million inhabitants with an average population density of 20 inhabitants/km2.
The Emergency Medical Service (EMS)-System: The ambulance staff in Sweden consists of registered nurses and emergency medical technician (EMT) equivalents (nursing assistants with special ambulance training).
Statistics: Hierarchical random effects models will be used to model the binary outcomes. Cox proportional hazards models to analyze the time to event outcomes. The difference in mean predicted outcome between the PHTLS group and the non-PHTLS group will be used to estimate the absolute risk reduction.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHTLS | – | –The exposure is defined from the dichotomization of the probability in each event/accident that at least one of the caring ambulance crew members was PHTLS certified. |
| No PHTLS | – | –Not exposed to PHTLS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study Population: Motor vehicle traffic crashes were selected using the causes of injury matrix developed by the National Center for Health Statistics, Centers for Disease Control and Prevention, USA.
Key inclusion criteria (2 listed)
- Primary incident hospital admissions due to traffic accidents or
- Death due to traffic accidents
Key exclusion criteria (1 listed)
- If a patient appears more than once, all but the first event will be excluded from the dataset.
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
Mortality before hospital admission.
Time frame: Patients will be followed up to death or at least one year after inclusion.
Injury deaths not associated with a hospital admission.
Mortality within 30 days.
Time frame: Patients will be followed up to death or at least one year after inclusion.
Deaths within 30 days including all deaths, prehospital and hospital, up to 30 days from the injury event.
Time to death among survivors to hospital admission.
Time frame: Patients will be followed up to death or at least one year after inclusion.
Time to death among patients associated with a hospital admission.
Return to work among survivors to hospital discharge.
Time frame: Patients will be followed up to occured event or at least one year after inclusion.
Number of patients returned to work per time-unit of observation after the injury event among all patients discharged from hospital, not dead, and that was working before the accident.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
- Background: PubMed 10754963Krug EG, Sharma GK, Lozano R. The global burden of injuries. Am J Public Health. 2000 Apr;90(4):523-6. doi: 10.2105/ajph.90.4.523.
- Background: PubMed 4812216Trunkey DD, Lim RC Jr, Blaisdell FW. Traumatic injury. A health care crisis. West J Med. 1974 Jan;120(1):92-4. No abstract available.
- Background: PubMed 7359667Collicott PE, Hughes I. Training in advanced trauma life support. JAMA. 1980 Mar 21;243(11):1156-9.
- Background: PubMed 20091538Jayaraman S, Sethi D. Advanced trauma life support training for ambulance crews. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003109. doi: 10.1002/14651858.CD003109.pub2.
- Background: PubMed 19370594Jayaraman S, Sethi D. Advanced trauma life support training for hospital staff. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004173. doi: 10.1002/14651858.CD004173.pub3.
- Background: PubMed 21122975Drimousis PG, Theodorou D, Toutouzas K, Stergiopoulos S, Delicha EM, Giannopoulos P, Larentzakis A, Katsaragakis S. Advanced Trauma Life Support certified physicians in a non trauma system setting: is it enough? Resuscitation. 2011 Feb;82(2):180-4. doi: 10.1016/j.resuscitation.2010.10.005. Epub 2010 Nov 30.
- Background: PubMed 22366502Johansson J, Blomberg H, Svennblad B, Wernroth L, Melhus H, Byberg L, Michaelsson K, Karlsten R, Gedeborg R. Prehospital Trauma Life Support (PHTLS) training of ambulance caregivers and impact on survival of trauma victims. Resuscitation. 2012 Oct;83(10):1259-64. doi: 10.1016/j.resuscitation.2012.02.018. Epub 2012 Feb 23.
- Background: PubMed 9301976Recommended framework for presenting injury mortality data. MMWR Recomm Rep. 1997 Aug 29;46(RR-14):1-30.
Related trials for Traffic Accidents
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Recruiting
Recovering Sleep After Trauma
Post-traumatic Stress Disorder
Recruiting
Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache
Pharmacologic Action
Not yet recruitingObservational study
Epidemiological and Statistical Study of Facial Traumatic Fractures at Assiut University Trauma Hospital
Facial Fractures, Maxillofacial Injuries
Active, not recruiting
Transportation Safety in Adolescence
Automobile Accident
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.
Rolf Gedeborg, PhD principal investigator
Uppsala University
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 Traffic Accidents, run by Uppsala University Hospital at 1 site in Sweden.
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 2 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: status not confirmed, as of the sponsor's last update on 23 May 2012. 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 Sweden. 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?
Results are not available in the source record.
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?
Mortality before hospital admission. (time frame: Patients will be followed up to death or at least one year after inclusion.). The study lists 4 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 NCT01603537, 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 23 May 2012.