Impact of replacing conventional emergency department diagnostic procedures by a single-pass whole body computed tomography (pan-scan) on the survival of patients with severe trauma
| ISRCTN | ISRCTN35424832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35424832 |
| Secondary identifying numbers | ukb_PATRES_3.2_0711 |
- Submission date
- 14/07/2011
- Registration date
- 24/08/2011
- Last edited
- 19/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Despite major improvements in emergency care, severe trauma, mainly due to road traffic crashes, falls, and assaults remains the leading cause of death in the industrialized countries. The rapid transfer of trauma victims to a specialized trauma centre is life-saving. On admission, the goal of diagnostic work-up is to identify life-threatening injuries, immediately followed by surgical and intensive care. The current diagnostic standard includes different imaging procedures like ultrasound, x-rays, and a cranial (head) computed tomography (CT) scan supplemented by CT scans of individual body regions as needed. In many trauma centres worldwide, this often time-consuming approach has now been replaced by a whole-body CT-scan, called the "pan-scan" for trauma. In theory, the pan-scan may detect injuries earlier and more precisely than the traditional stepwise procedure. Although compelling and plausible, there is a lack of evidence of whether the pan-scan benefits patients in terms of improved survival. The potential advantages of the pan-scan must also be traded-off against the increased exposure to radiation. The aim of this study is to find out whether the introduction of pan-scan into trauma resuscitation decreases mortality (death rate) for patients after severe blunt trauma compared to a conventional, staged work-up.
Who can participate?
Patients with suspected blunt multiple trauma requiring resuscitation in the emergency department/trauma bay
What does the study involve?
The outcomes of patients admitted before and after the introduction of pan-scan for severe trauma are compared. Mortality (death rate), adjusted for injury severity and other factors, morbidity (i.e. inflammatory complications like lung failure and multiple organ failure), and emergency department time are assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The University Trauma Centres in Murnau and Greifswald (Germany)
When is the study starting and how long is it expected to run for?
July to October 2011
Who is funding the study?
Investigator initiated and funded (Germany)
Who is the main contact?
Dr Dirk Stengel
zkf@ukb.de
Contact information
Scientific
Emergency Hospital Berlin (Unfallkrankenhaus Berlin)
Warener Str. 7
Berlin
12683
Germany
| Phone | +49 (0)30 5681 4090 |
|---|---|
| zkf@ukb.de |
Study information
| Study design | Retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effectiveness of primary whole-body computed tomography (pan-scan) in improving process and outcome quality after severe and multiple trauma (The Pan-scan for Trauma Resuscitation Study, Part 3) |
| Study acronym | PATRES-3 |
| Study objectives | The introduction of a single-pass whole-body, contrast-enhanced computed tomography (Pan-Scan) into trauma resuscitation decreases all-cause in hospital mortality of patients after severe blunt trauma compared to a conventional, staged work-up algorithm |
| Ethics approval(s) | Bavarian Chamber of Physicians (Bayerische Landesärztekammer), 16/03/2010 |
| Health condition(s) or problem(s) studied | Multiple and severe blunt trauma |
| Intervention | 1. Control cohort: Trauma resuscitation and staged diagnostic work-up according to Advanced Trauma Life Support (ATLS(R)) standards including physical examination (ABCDE-algorithm), focused assessment with sonography for trauma (FAST, including thoracic views), plain x-rays of the chest, pelvis, and spine, cranial CT, followed by selective CT-scans of suspicious body regions 2. Intervention cohort: Trauma resuscitation and staged diagnostic work-up according to Advanced Trauma Life Support (ATLS(R)) standards, primary single-pass pan-scan |
| Intervention type | Other |
| Primary outcome measure | All-cause in-hospital mortality |
| Secondary outcome measures | 1. All-cause in-hospital mortality, adjusted for injury severity and other confounding / interaction variables identified by multivariable logistic regression analysis 2. Morbidity (i.e. inflammatory complications like lung failure [ARDS] multiple organ failure [MOF]) 3. Emergency department time |
| Overall study start date | 15/07/2011 |
| Completion date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 300 per group |
| Key inclusion criteria | Consecutive men and women (no age restrictions) with suspected blunt multiple trauma directly transferred from the scene to the hospital and requiring resuscitation in the emergency department / trauma bay |
| Key exclusion criteria | Due to the retrospective nature of this analysis only patients with insufficient or lacking information in the hospital documentation system will be excluded from the analysis |
| Date of first enrolment | 15/07/2011 |
| Date of final enrolment | 01/10/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
12683
Germany
Sponsor information
Hospital/treatment centre
Warener Str. 7
Berlin
12683
Germany
| Phone | +49 (0)30 5681 4090 |
|---|---|
| zkf@ukb.de | |
| Website | http://www.ukb.de/ |
"ROR" |
https://ror.org/011zjcv36 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/12/2011 | Yes | No |
Editorial Notes
19/04/2017: Plain English summary added.
