Trauma Clinical Trial
Official title:
Evaluation of a University Hospital Trauma Team Activation Protocol: a Prospective Cohort Study
The aim of the study is to establish the predictive properties of our trauma team activation
protocol, and its individual criteria, and if possible to suggest changes that reduce over-
and undertriage.
The study will also give an overview of the frequency and type of emergency procedures at a
university hospital trauma center, which can contribute to optimal resource use and indicate
which type of surgical skills are necessary in our trauma emergency procedures.
1. Background Multidisciplinary trauma teams reduce mortality and have become an important
part of modern trauma care. Activation of the trauma team (TTA) when receiving patients
with potentially severe injuries and protocols for TTA, are widely implemented
throughout Scandinavia. Trauma team activation guidelines vary somewhat among
Scandinavian trauma centers, but resemble the recommendations from the American College
of Surgery - Committee On Trauma (ACS-COT). The criteria are based on parameters of
physiologic compromise, anatomic injury classification, and mechanism of injury (MOI).
They are designed to prevent undue delay of vital care as the trauma team is activated
when prehospital information indicates that at least one of the TTA criteria is
fulfilled. A substantial overtriage (activation of the trauma team despite only minor
or moderate injury) is common and may reach 70%, mostly reflecting the limited
precision of criteria relating to MOI. Overtriage is mainly a resource problem, as
assembly of the multidisciplinary trauma team diverts personnel from other important
activities in the hospital. Undertriage delays diagnosis and treatment of severely
injured patients and may compromise the clinical outcome and even increase mortality.
ACS-COT suggests that an overtriage as high as 50% is acceptable in order to minimize
undertriage.
Triage criteria should be adapted to the local case-load and injury pattern, which may
vary considerably between geographical regions. The predictive properties of triage
criteria depend on the prevalence of severe injuries. Typical for most Scandinavian
trauma hospitals is a predominance of blunt over penetrating injuries. Furthermore, the
frequency of severe polytrauma admissions is low.
In 2011, we published an evaluation of the trauma team activation protocol in our
hospital, leading to a change in the criteria. This study represents an evaluation of
those changes and also addresses whether there may be a potential for further
improvements.
2. Aim of the study The aim of the study is to establish the predictive properties of our
TTA protocol, and its individual criteria, and if possible to suggest changes that
reduce over- and undertriage.
The study will also give an overview of the frequency and type of emergency procedures
at a university hospital trauma center, which can contribute to optimal resource use
and indicate which type of surgical skills are necessary in our trauma emergency
procedures.
3. Method Identification of patients and inclusion-/exclusion criteria The trauma register
at UNN Tromsø registers all patients admitted with TTA. Also included are patients with
penetrating injury to the head/neck/torso/extremities proximal for elbow or knee, all
patients with New Injury Severity Score (NISS) >12 and all patients with a head injury
with AIS≥3. Excluded from the trauma register are patients with a chronic subdural
hematoma, and patients with injuries from drowning, inhalation and asphyxia
(strangulation/hanging).
From the patients in the trauma register in the time period 1.2.2013 - 31.01.2015, we
will identify and include patients.
Data collection Almost all necessary data will be available from the trauma register.
Criteria used for activation of the trauma team, is not registered in the trauma
registry, and hence, will be registered from the documentation in the emergency medical
dispatch centre (AMK) in Tromsø.
Classification of injuries All injuries will be classified according to the Abbreviated
Injury Scale (AIS)) and the extent of injuries will be classified with the Injury
Severity Scale (ISS). Both classifications will be performed by authorized registrars.
Triage The TTA protocol is evaluated against two standards, ISS and emergency
procedure. Triage is considered correct when ISS>15 or an emergency procedure is
performed aimed at stabilizing respiration or circulation. Overtriage is defined as the
fraction of TTA where the patients are not severely injured (ISS≤15) or did not receive
an emergency procedure. Undertriage is defined as the fraction of severely injured
(ISS>15) or an emergency procedure was performed, and the patient was admitted without
TTA.
The ability of a criterion to predict severe trauma and/or need for an emergency
procedure, is given as the percentage of patients that fulfilled the specific criterion
that also had an ISS >15 and/or were subject to an emergency procedure.
Hypothesis Previously, there was an undertriage of 12 % and an overtriage at UNN Tromsø
of 70 %. On the 01.04.2011, the trauma team activation protocol at UNN Tromsø was
revised, and of the previously 27 criteria, five criteria had been removed. We plan to
assess if the current protocol has lead to an improvement in under- and overtriage. We
also want to identify criteria which are seldom used (< 5 % of patients) and/or with a
low positive predictive value (< 10 %), and these criteria will be considered omitted.
A last hypothesis is to analyze if "walking wounded" is safe to admit without
mobilizing the trauma team (a "walking wounded" patient is an injured patient with no
loss of conscience and is up and walking on his own), given that there is enough
prehospital information to assess this.
4. Design The study is a prospective cohort study, based on data from the trauma register
at UNN Tromsø.
5. Parameters
Baseline characteristics for included patients are:
- sex
- age
- mechanism of injury
- classification of injuries with AIS and ISS
- transfer from other hospitals
Outcome parameters include
- type and frequency of emergency procedures performed at the local hospital and at
UNN Tromsø
- Criteria used for trauma team activation.
- mortality
Emergency procedures includes:
- Chest tube insertion
- Hemostatic surgery in the abdomen
- Hemostatic surgery in the pelvis with packing
- Thoracotomy
- Primary stabilization of fractures (external fixation)
- Endotracheal intubation (our addition)
6. Statistical methods Simple statistical methods like frequency, mean, median and
percentage will be used.
7. Study group Supervisor is dr.med. Kristian Bartnes, Avd. for hjerte-/lunge-/karkirurgi,
UNN.
Coworkers are dr.med. Knut Fredriksen, Akuttmedisinsk avd. UNN; cand.med. Svein Arne
Monsen, Anestesiavd. UNN and cand.med. Trond Dehli, Gastrokirurgisk avd, UNN.
Trond Dehli is responsible for the practical follow-up of the study.
8. Time Schedule Data collection will start 1.2.13 and continue until 31.01.15. Since
registration of data in the trauma registry most likely will be delayed by 2-12 weeks,
the registration of data will continue until all patients in the registry are
completed. Presentation of the study in the form abstract/posters and a manuscript will
be written during 2015.
9. Ethics and publication The protocol will be sent to the regional ethical committee for
approval. We plan to present the results in national and international conferences, and
also in a peer-reviewed medical journal.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Terminated |
NCT03781817 -
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
|
Phase 4 | |
Completed |
NCT04342416 -
Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
|
N/A | |
Recruiting |
NCT04856449 -
DBT Skills Plus EMDR for BPD and Trauma
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Completed |
NCT05669313 -
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
|
||
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Recruiting |
NCT04725721 -
Testing FIRST in Youth Outpatient Psychotherapy
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Not yet recruiting |
NCT03696563 -
FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
|
N/A | |
Withdrawn |
NCT03249129 -
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
|
||
Completed |
NCT02240732 -
Surgical Tourniquets and Cerebral Emboli
|
N/A | |
Completed |
NCT02227979 -
Effects of PURPLE Cry Intervention
|
N/A | |
Withdrawn |
NCT01169025 -
Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients
|
N/A | |
Recruiting |
NCT01812941 -
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
|
N/A | |
Completed |
NCT01475344 -
Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
|
Phase 1/Phase 2 | |
Completed |
NCT03112304 -
Child STEPS for Youth Mental Health in Maine Sustainability
|
N/A | |
Completed |
NCT01201863 -
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
|
Phase 4 | |
Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A |