To compare the effects of the rapid and detailed information of organ and tissue injury from primary *total body* CT scanning with standard conventional ATLS based radiological imaging during the primary survey, on clinical outcome and long term…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
ernstige traumatische letsels
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The in-hospital mortality
Secondary outcome
- The difference in mortality: the 24hour mortality and the mortality during
the first year after the trauma.
- The difference in morbidity: the complications and total number of
re-interventions
and re-admissions during the first year after the trauma.
- The difference in hospital time: the length of in-hospital and ICU stay and
the total
number of ventilation days.
- The difference in quality of life 6 and 12 months after the trauma as
recorded by
filling in two questionnaires (HUI-3 and EuroQoL).
- The difference in ratio of non-operative management strategies: i.e.
conservative
and angio-interventional treatment versus primary operations.
- The difference in radiation exposure between total body CT and standard
work-up.
- The difference in diagnostic time and between total body CT and standard
work-up.
- The difference in cost-effectiveness (measured by a patient questionnaire
derived from the Dutch Labour and Health Questionnaire and adapted for
international use 3 and 6 months after the trauma).
- The difference in diagnostic accuracy between total body CT and standard
work-up.
Background summary
Trauma is a major cause of mortality and morbidity throughout the world,
especially in the younger people below the age of 50 years. In the Netherlands
annually 990.000 patients visit the emergency department (ED) after an injury
and 5300 people die after an accident. Time, accuracy and specificity are of
great importance in evaluating trauma patients before further treatment is
planned. The ongoing development of modern imaging techniques makes them both
faster and more accurate. Nowadays, imaging techniques become increasingly more
available in the emergency department or trauma resuscitation room itself. With
these technical and infrastructural improvements, the current (imaging)
guidelines according to the ATLS may not represent the optimal primary imaging
algorithm anymore. Especially Computed Tomography (CT) has evolved as a
reliable and important method of diagnostic imaging in trauma. Both (solid)
organ and osseous injuries can be diagnosed and (life-threatening) bleeding
sites can be identified. The CT scanners used to be too time consuming and
usually have been located at other departments of the hospital. Modern CT
scanners are fast and more frequently available in the ED. This allows fast and
detailed diagnoses for well-founded planning of further therapy.
Study objective
To compare the effects of the rapid and detailed information of organ and
tissue injury from primary *total body* CT scanning with standard conventional
ATLS based radiological imaging during the primary survey, on clinical outcome
and long term effects on Quality of Life of severely injured trauma patients.
Study design
A multicenter prospective randomized trial in several Level-1 trauma centers;
with a CT scanner located in the trauma resuscitation room or emergency
Department. The *total body CT scan* group will only receive a *total body* CT
scan in the primary survey and the conventional group will be evaluated
according to the local conventional trauma protocol (based on the ATLS
guidelines).
Intervention
the total body CT scan without prior conventional imaging
Study burden and risks
All patients will receive optimal trauma care. Patients who are presented in
our trauma resuscitation room will either get a primary *total body* CT scan or
will be evaluated according to our conventional ATLS guidelines based protocol.
Because any patient can be withdrawn at any moment from this study protocol by
the leading trauma surgeon or anaesthesiologist there are no extra risks for
the patient.
If there are two trauma patients presented at the same time the latter patient
will be excluded and evaluated according to our conventional protocol in
another trauma room with bucky equipment.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
At least one of the following parameters at hospital arrival:
- respiratory rate *30 or *10, or
- pulse *120/min
- systolic blood pressure *100 mmHg
- exterior blood loss *500 ml
- Glasgow Coma Score *13 or abnormal pupilary reaction on site.;Or one of the following clinically suspicious diagnoses:
- Patients with signs of fractures from at least two long bones
- Patients with clinical signs of flail chest, open chest or multiple rib fractures
- Patients with clinical signs of severe abdominal injury
- Patients with a clinically evident pelvic fracture
- Patients with signs of unstable vertebral fractures or signs of spinal cord compression;Or one of the following injury mechanisms:
- fall from height (>3 meters / > 10 feet)
- ejection from the vehicle
- death occupant in same vehicle
- severely injured patient in same vehicle
- wedged or trapped chest / abdomen
Exclusion criteria
- Age <18 years (if known)
- Known pregnancy
- Patients referred from other hospitals
- Any patient with a penetrating head / neck injury (except gun shot wounds) as the clearly isolated injury as judged by the trauma leader
- Any patient who is judged to be too unstable to undergo a CT scan and requires (cardiopulmonary) resuscitation or immediate operation because death is imminent, according to the trauma team leader in mutual agreement with the other leading care givers.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21352.018.08 |