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Optimizing the initial evaluation and management of severe trauma patients

Optimizing the initial evaluation and management of severe trauma patients

UITNODIGING  

Voor het bijwonen van de openbare verdediging van het proefschrift  

OPTIMIZING THE INITIAL EVALUATION AND MANAGEMENT OF SEVERE TRAUMA PATIENTS  

van T.P. Saltzherr   op vrijdag 27 mei 2011 om 13.00u   in de aula van de Lutherse kerk Singel 411, hoek Spui 1012 WN Amsterdam   Receptie na afloop van de promotie

T.P. Saltzherr

Teun Peter Saltzherr

  Paranimfen Niels Molenaar 06-10158231 niels.molenaar@amsterdam. allenovery.com     Mark van Heijl 06-41821900 [email protected]     T.P. Saltzherr Hemonystraat 70-2 1074 BT Amsterdam [email protected]

Optimizing the initial evaluation and management of severe trauma patients

The printing of this thesis was financially supported by: Universiteit van Amsterdam, GlaxoSmithKline B.V., Philips Healthcare Benelux, Siemens Nederland B.V., Afdeling Chirurgie AMC, Bauerfeind Benelux B.V., Chipsoft B.V., Nederlandse Vereniging voor Traumatologie en Traumanet AMC.

The REACT trial was financially supported by a grant from ZonMw, the Netherlands organisation for health research and development (Grant number 3920.0005).

Optimizing the initial evaluation and management of severe trauma patients Thesis, University of Amsterdam, the Netherlands Copyright © 2011 Teun Peter Saltzherr, the Netherlands No part of this thesis may be reproduced, stored or transmitted without prior permission of the author.

Printed by: Gildeprint Drukkerijen - the Netherlands

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Optimizing the initial evaluation and management of severe trauma patients

ACADEMISCH PROEFSCHRIFT

Ter verkrijging van de graad van doctor aan de Universiteit van Amsterdam op gezag van de Rector Magnificus Prof. Dr. D.C. van den Boom ten overstaan van een door het college voor promoties ingestelde commissie, in het openbaar te verdedigen in de Aula der Universiteit

op vrijdag 27 mei 2011, te 13:00 uur

door

Teun Peter Saltzherr

Geboren te de Bilt

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Promotiecommissie Promotor:

Prof. Dr. J.C. Goslings

Co-promotoren: Dr. K.J. Ponsen Dr. J.B. Reitsma Overige leden: Dr. F.C. Bakker Prof. Dr. P.M.M. Bossuyt Prof. Dr. H.J.Ten Duis Prof. Dr. M.W. Hollmann Prof. Dr. C. van Kuijk Prof. Dr. J.S. Lameris

Faculteit der Geneeskunde, Universiteit van Amsterdam

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5

Table of contents Chapter 1:

Introduction and outline

PART I

Implementation of a modern trauma resuscitating room.

Chapter 2:

An evaluation of a shockroom located CT scanner: a

9

17

randomized study of early assessment by CT scanning in trauma patients in the bi-located trauma center NorthWest Netherlands (REACT trial). Chapter 3:

Randomized trial comparing the value of a CT scanner in

29

the trauma room with a CT scanner in the radiology department; the REACT trial. Chapter 4:

A cost-effectiveness Analyses of a trauma resuscitating

53

room with a sliding, multislice CT scanner.

PART II

Radiographic imaging during the primary survey of severe trauma patients.

Chapter 5:

Clearing the cervical spine in Dutch trauma care; a

71

problem-analysis. Chapter 6:

Diagnostic imaging of cervical spine injuries following blunt trauma. A review of the literature and practical guideline.

6

83

Chapter 7:

Frequent Computed Tomography scanning due to

101

incomplete three-view X-ray imaging of the cervical spine. Chapter 8:

Are routine repeat chest X-rays before leaving the trauma

113

room useful?

PART III

Sequelae of the initial evaluation and management of severe trauma patients.

Chapter 9:

Complications in multitrauma patients in a Dutch Level-1

125

trauma center. Chapter 10:

Missed injuries in Dutch Level-1 trauma patients.

139

Chapter 11:

Preventability of trauma deaths in a Dutch Level-1 trauma

153

center. Chapter 12:

The value of post mortem Computed Tomography as a

165

reliable substitute for autopsy. A systematic review. Chapter 13:

Summary

184

Chapter 14:

Samenvatting

191

Chapter 15:

General discussion and future perspectives

199

Dankwoord

205

Curriculum vitae

209

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8

1 Introduction and outline

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Introduction and outline Impact of trauma Worldwide trauma is a major cause of morbidity and accounts for 10% of mortality, especially in people younger than 50 years.1 The Netherlands has 5300 trauma deaths every year, while 1500-2000 multitrauma patients are presented at Level-1 trauma centers.2 Injury accounts for 14% of all disability-adjusted life years (DALY’s), especially because the trauma population consists of young people without pre-existent morbidity, making trauma an important source of health-related 2

costs. The annual direct (medical) costs are approximately 1 billion Euros while the indirect costs, as a result of decreased production capacity, and immaterial losses are 4 billion Euros. More than 80% of those patients who die from injury succumb within 6 hours after injury. Most deaths in trauma victims are due to head injury (40%), uncontrollable bleeding (30%) and chest injuries (20%) as early causes of death and sepsis, multi-organ failure and pulmonary embolism as late causes of death.3 Blunt trauma (i.e. motor vehicle accidents, fall from heights etc.) is still the most common mechanism of injury in the Netherlands although penetrating injuries are becoming more common due to the increasing violence. Initial trauma evaluation Time management, accuracy and specificity are of great essence in trauma care. The more rapid and accurate injuries are diagnosed and treated, the better patient’s short and long-term outcomes. Initial care for trauma patients is globally based on Advanced Trauma Life Support (ATLS®) guidelines, which were first introduced in 1980.4 ATLS dictates that the greatest threats to life should be treated first.4 Therefore, ALTS consists of a systematic approach of clinical examination and diagnostics in order of priority managed by a multidisciplinary team (i.e. trauma surgeons, radiologists and anesthesiologists). The initial patient’s assessment consists of a rapid primary evaluation and resuscitation of vital functions. When the patient demonstrates normal vital functions, or normalizes after acute interventions, the secondary survey is started with a head to toe

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examination and the radiological evaluation. If an injury is diagnosed, treatment should be started immediately. The radiological evaluation consists of conventional chest, C-spine and pelvic radiographs and abdominal ultrasonography. CT scanning is advised to be performed selectively (‘on indication’). After the initial evaluation of the patient all life-threatening injuries are known and if necessary the patient is transported to the destination where (definitive) treatment can be offered (OR, ICU, Angiosuite, ward). Less severe injuries can be diagnosed and/or treated in a later phase when necessary or after the secondary survey in the trauma room when life-threatening injuries are excluded or have been treated. After 24 hours, assuming the patient has stabilized or has regained consciousness, the patient is checked once again for potentially missed injuries (‘tertiary survey’) and when necessary specific radiological examinations are performed.

4-6

Modern trauma room Trauma care has changed drastically since the introduction of a structured and standardized initial evaluation of trauma patients. Appointing designated trauma centers for specialized trauma care all over the world decreased trauma-related mortality even further.7-9 As a result of the ongoing development of imaging techniques and treatment protocols the outcomes of trauma care are continuously improving. The influence of CT scanning as an early diagnostic tool is increasing because it is becoming faster and can give a more detailed overview of sustained injuries than conventional imaging (X-rays and ultrasonography). Furthermore, CT scanners are increasingly becoming available in the Emergency Departments which facilitates obtaining a very early CT scan.10-12 In the Academic Medical Center (AMC) a concept was developed and implemented in January 2004 that brought the CT scanner to the patient instead of the patient to the scanner by locating the CT scanner within the trauma room itself. Its main feature is a radiolucent trauma resuscitation table and a multislice CT scanner placed on rails which can slide over the patient. When necessary it can also slide to a second mirrored trauma room which is separated by radiation shielded doors, to proceed with an additional

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(trauma) patient In addition, facilities for conventional X-ray imaging and ultrasonography are also readily available. With this concept the most important diagnostic modalities for trauma evaluation are at hand in the trauma room and CT scanning is possible at any moment during the initial trauma evaluation. Methods for quality assessment Trauma care is susceptible to medical errors or mismanagements due to initial unknown diagnoses, indicating the necessity of rapid diagnosis and treatment in a sometimes stressful environment.

13,14

Therefore, continuous evaluation and

optimisation of the quality of trauma care is necessary. The abovementioned ongoing changes in imaging and treatment protocols make it even more important to monitor the outcomes and quality of the delivered care. Several methods are applied in evaluating trauma care, i.e. post-mortem examination or discussion panels to evaluate potential errors or preventable deaths. Outline of the thesis In this thesis several aspects for the optimization of the initial evaluation and care of trauma patients are discussed. This manuscript is divided in three parts. In Part I we describe the effects of a modern trauma room containing a sliding, multislice CT scanner on trauma care. Part 2 is focused on the evaluation and optimization of existing radiological imaging protocols. In Part 3 several sequelae of trauma care in a Dutch level-1 trauma center are analyzed and methods for quality assessment of trauma care are critically appraised. Part I: The first chapters of this thesis report on clinical outcomes, logistics and costs associated with a modern trauma room containing a sliding, multislice CT scanner. These outcomes have been assessed in the REACT study which is a randomized controlled trial comparing trauma care in a setting with a CT scanner located in the trauma room with a setting having the CT scanner at the Radiology Department. The design and rationale of the REACT study are described in Chapter 2.

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In Chapter 3 we describe the results of this randomized controlled trial on clinical outcomes and logistics. Chapter 4 provides an accurate overview and comparison of all in-hospital and trauma related healthcare costs involved up to one year after the initial trauma for both strategies. Based on the outcomes of these studies, a well-considered decision can be made for which (category of) patients and hospitals early CT scanning could be beneficial. Furthermore, recommendations are formulated about key issues to address in future research. Part II: Most of the radiological imaging protocols used in Dutch Emergency Departments are based on the internationally accepted ATLS guidelines. However, over the years several adaptations and protocol changes have been carried through. Several evidence based decision rules exist for clearing the cervical spine (Cspine) in blunt trauma patients. However, there is still no uniform policy for the use of one of these decision rules in Dutch ED's. To investigate which factors hinder the implementation of such validated decision rules, we performed a nationwide problem analysis for clearing the C-spine with clinical decision rules. The outcomes of this problem analysis are described in Chapter 5. Chapter 6 contains the results of a systematic review of available studies on radiological imaging for C-spine clearance. Based on the findings from the review two patient groups are described to facilitate decision making. Finally, this chapter provides two flowcharts which could help in decision making for radiological imaging in daily practice. Subsequently, we were interested in the amount of CT scans performed after primary X-ray imaging of the C-spine. After assessing the reasons for secondary CT scanning we analyzed several clinically useful markers which increase the risk of inadequate C-spine X-ray imaging in Chapter 7.

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Another deviation from the ATLS guidelines is that many hospital protocols include a routine repeat chest X-ray during the secondary survey rather than on indication only. Because no real evidence exists for this historical habit, we assessed the utility and clinical impact of a routine repeat chest X-ray in Chapter 8. Part III: Constant monitoring of current standards of trauma care is required to provide optimal trauma care. Critical appraisal of one’s own errors or complications should be part of this process. Therefore, the final part of the thesis describes several methods to monitor the quality of trauma care. Trauma patients seem to be at high risk for developing complications. This can be due to the physiological and immunological impact of trauma or due to specific trauma patient or treatment characteristics such as long-lasting ventilation or immobilization. In Chapter 9 the amount, anatomical location and consequences of complications in multitrauma patients are described. With the outcomes of this study we want to emphasize that certain patients are more prone for complications. Chapter 10 describes the results of a study in which the incidence of missed injuries was assessed within the REACT study population. In this analysis the different phases in which the injuries were diagnosed were distinguished, which makes it possible to optimize both the initial trauma care as well as the phase of follow-up examination. An assessment of preventability of trauma deaths and errors in management is an accepted method to evaluate the quality of trauma care. Historically in the Academic Medical Center Amsterdam this assessment is performed during a monthly Morbidity and Mortality meeting. Subsequently, to assess the adequacy and outcomes of this meeting an external and independent review panel of traumaspecialists was asked to review the evaluation and trauma care of 62 trauma victims in the AMC. Aim of this study was to optimize both delivered trauma care

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as well as the internal evaluation system. The outcomes of this external review process are described in Chapter 11. Post-mortem patient examination can be an important method to evaluate the outcome of the process of trauma management with the purpose to further improve the quality of trauma care. This is because this examination can reveal missed injuries or uncertain causes of deaths. This outcome can be relevant for the treatment of future trauma patients, if they lead to further optimization of trauma management. The current golden standard for this type of post mortem examination is autopsy. However, this method is time consuming, labour intensive and very invasive. Furthermore, the permission which is in general required to perform such an examination is often denied by the victim’s family. In Chapter 12 the outcomes of a systematic review which assesses the value of post-mortem CT scanning as a potential substitute for autopsy are described. Finally, in Chapter 13 and 14 the findings of the preceding chapters are summarized and discussed. Brief recommendations for future research and guidelines are given.

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Reference list 1. 2. 3.

4. 5. 6. 7.

8. 9. 10.

11.

12.

13.

14.

World Health Organization: 2008 [http://www.who.int/topics/injuries/en/]. World Health Organization: Regional Office for Europe. 2008 [http://www.euro.who.int/violenceinjury]. Acosta JA, Yang JC, Winchell RJ, Simons RK, Fortlage DA, Hollingsworth-Fridlund P, Hoyt DB. Lethal injuries and time to death in a level I trauma center. J Am Coll Surg. 1998 May;186(5):52833. Committee on Trauma: American College of Surgeons: Advanced Trauma Life Support (ATLS®); for Physicians, 7th Edition Chicago; 1997. Enderson BL, Reath DB, Meadors J, Dallas W, DeBoo JM, Maull KI. The tertiary trauma survey: a prospective study of missed injury. J Trauma. 1990 Jun;30(6):666-9; discussion 669-70 Biffl WL, Harrington DT, Cioffi WG. Implementation of a tertiary trauma survey decreases missed injuries. J Trauma. 2003 Jan;54(1):38-43 Increased survival among severe trauma patients: the impact of a national trauma system. Peleg K, Aharonson-Daniel L, Stein M, Kluger Y, Michaelson M, Rivkind A, Boyko V; Israel Trauma Group. Arch Surg. 2004 Nov;139(11):1231-6. Champion HR, Sacco WJ, Copes WS. Improvement in outcome from trauma centre care. Arch Surg. 1992; 127: 333–338. Sampalis JS, Lavoie A, Boukas S, et al. Trauma center designation: initial impact on traumarelated mortality. J Trauma. 1995; 39: 232–239. Lee KL, Graham CA, Lam JM, Yeung JH, Ahuja AT, Rainer TH. Impact on trauma patient management of installing a computed tomography scanner in the emergency department. Injury. 2009 Aug;40(8):873-5. Gralla J, Spycher F, Pignolet C, Ozdoba C, Vock P, Hoppe H. Evaluation of a 16-MDCT scanner in an emergency department: initial clinical experience and workflow analysis. AJR Am J Roentgenol. 2005 Jul;185(1):232-8. Gross T, Messmer P, Amsler F, Füglistaler-Montali I, Zürcher M, Hügli RW, Regazzoni P, Jacob AL. Impact of a multifunctional image-guided therapy suite on emergency multiple trauma care. Br J Surg. 2010 Jan;97(1):118-27. Gruen RL, Jurkovich GJ, McIntyre LK, et al. Patterns of errors contributing to trauma mortality: lessons learned from 2,594 deaths. Ann Surg 2006;244: 371–80. MacLeod JB, Cohn SM, Johnson EW, McKenney MG. Trauma deaths in the first hour: are they all unsalvageable injuries? Am J Surg 2007;193:195–9.

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2 An evaluation of a shockroom located CT scanner: a randomized study of early assessment by CT scanning in trauma patients in the bi-located trauma center North-West Netherlands (REACT trial) TP Saltzherr PHP Fung Kon Jin FC Bakker KJ Ponsen JSK Luitse M Scholing JF Giannakopoulos LFM Beenen CP Henny GM Koole JB Reitsma MGW Dijkgraaf PMM Bossuyt JC Goslings

BMC Emerg Med. 2008 Aug 22;8:10

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Abstract Background: For the evaluation of trauma patients CT scanning has gained wide acceptance in and provides detailed information on location and severity of injuries. However, CT scanning is frequently time consuming due to logistical (location of CT scanner elsewhere in the hospital) and technical issues. An innovative and unique infrastructural change has been made in the AMC in which the CT scanner is transported to the patient instead of the patient to the CT scanner. As a consequence, early shockroom CT scanning provides an all-inclusive multifocal diagnostic modality that can detect (potentially life-threatening) injuries in an earlier stage, so that therapy can be directed based on these findings. Methods: The REACT-trial is a prospective, randomized trial, comparing two Dutch level-1 trauma centers, respectively the VUmc and AMC, with the only difference being the location of the CT scanner (respectively in the Radiology Department and in the shockroom). All trauma patients that are transported to the AMC or VUmc shockroom according to the current prehospital triage system are included. Patients younger than 16 years of age and patients who die during transport are excluded. Randomization will be performed prehospitally. Study parameters are the number of days outside the hospital during the first year following the trauma (primary outcome), general health at 6 and 12 months post trauma, mortality and morbidity, and various time intervals during initial evaluation. In addition a cost-effectiveness analysis of this shockroom concept will be performed. Regarding primary outcome it is estimated that the common standard deviation of days spent outside of the hospital during the first year following trauma is a total of 12 days. To detect an overall difference of 2 days within the first year between the two strategies, 562 patients per group are needed. (alpha 0.95 and beta 0.80). Discussion: The REACT-trial will provide evidence on the effects of a strategy involving early shockroom CT scanning compared with a standard diagnostic imaging strategy in trauma patients on both patient outcome and operations research.

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Background Trauma is the most common cause of death in people younger than 50 years of age and accounts for more years of life lost than cancer, heart disease, and stroke combined. Injuries cause 5 million deaths every year worldwide (9% of global mortality).1 In Europe alone injuries account for approximately 800,000 deaths 2

(10% of all deaths) and 14% of all disability-adjusted life years (DALY). Injuries are an important source of medical costs, economic losses, and immaterial losses. Trauma can therefore be regarded as a neglected epidemic. For improving the trauma care specialized trauma centers are designated and ®

specialized trauma care protocols, like the worldwide used ATLS guidelines, were developed.[3] Because there is a narrow window of opportunity between the moment that a patient deteriorates and actually dies, the ATLS guidelines prioritize care and focus on (potentially) life-threatening injuries rather than distracting but less important injuries. As a consequence a systematic approach of clinical examination and diagnostics is developed to recognize the most life-threatening injuries first. These should be treated immediately and preferably within ‘the golden hour’.3 The imaging studies most frequently used in trauma patients include conventional X-rays, ultrasonography (FAST), and computed tomography scanning (CT). Although conventional X-rays and ultrasonography are widely used and easily accessible for many institutions, they have a limited sensitivity for injuries such as spine fractures,4 pulmonary contusion, rib fractures, pneumothoraces or vascular injuries to the mediastinum,5-8 and intra-abdominal, pelvic and retroperitoneal injuries.9,10 Also, the amount of time necessary to obtain an overview of all the injuries is limited. Recent improvements in CT technology with respect to image quality and speed have led to an increasingly important role of CT scanning in management of severely injured patients. However, the biggest problem with CT scanning is that this technique is frequently time-consuming due to logistical (location of CT scanner in other departments of the hospital) and technical issues. This implies that CT can only be used in hemodynamically stable patients where time to OR for

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surgical stabilization is a less critical factor. Furthermore, the fact that the same CT scanner is scheduled for elective patients as well as trauma patients means that an unplanned, prioritized trauma patient will disrupt the scheduled patient care and logistics and will lead to increased waiting times. In order to improve patient care and workflow in acute trauma patients, the Academic Medical Center (AMC) in Amsterdam, the Netherlands, has initiated a project together with Siemens Inc. A new and revolutionary concept was developed in which the CT scanner is transported to the patient instead of the patient to the CT scanner. Main feature is a radiolucent trauma resuscitation table and a CT scanner that slides over the patient in the trauma resuscitating room. In addition there are also possibilities for conventional X-ray imaging and ultrasonography. With this concept the most important diagnostic modalities for trauma evaluation are available in the shockroom and CT scanning is possible at any moment during initial trauma evaluation. Furthermore, no further transport and patient transfers are required which can endanger the patient itself during the diagnostic phase (potentially leading to dislodgement of tubes, lines, cables, etc). Overall this concept will likely result in a faster and improved workflow and diagnostic imaging of trauma patients. Methods/design Study objectives: The primary objective is to prove the beneficial effects of early shockroom CT scanning on trauma patients by comparing the effects of a strategy involving early shockroom CT scanning with a standard diagnostic imaging strategy on patient outcome. In the latter strategy the CT scan is not located in the shockroom, but elsewhere in the hospital. The secondary objectives are to document the impact of introducing shockroom CT-scanning on logistics, capacity utilization, waiting times, economies of scale, substitution patterns, and investments. Study design: The REACT-trial is a prospective, patient-randomized study that will compare the clinical work-up of trauma patients in a setting where the CT scanner is located in the shockroom (AMC) with the standard situation where CT scanning takes place at the Radiology Department (VUmc).

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Setting/Participating centers: The Trauma Center North-West Netherlands is one of 10 designated Level-I trauma centers in the Netherlands. It is constituted by the ‘Vrije Universiteit’ medical center (VUmc) and the Academic Medical Center (AMC), which are both located approximately 8 kilometers apart from each other in Amsterdam. Each of these two hospitals, together with the surrounding affiliated hospitals, is responsible for the care of trauma victims in its region (2.7 million inhabitants in total) that are distributed over these hospitals. In both hospitals, patients are evaluated by a multidisciplinary team in the trauma resuscitation room ('shockroom'), which is fully equipped for initial management of trauma patients, including conventional X-rays and ultrasonography. The initial evaluation of trauma patients after arrival is according to ATLS guidelines and the same in both hospitals. After the primary survey, standard Xrays (i.e. thorax, pelvis and cervical spine) and sonography will be done according to the ATLS guidelines. In the VUmc the CT scanner (64-slice) is located in the Radiology Department on the second floor. This requires transportation of the patient with at least 4 patient transfers from trolley to the CT table and vice versa. In the AMC a concept was developed in which the CT scanner is transported to the patient instead of the patient to the CT scanner. Main feature is a radiolucent trauma resuscitation table and a 4-slice CT scanner (SOMATOTOM Sensation 4, Siemens) placed on a rail which enables the scanner to slide over the patient. Because of a mirrored design of a second shockroom that is separated by radiation shielded sliding doors the CT scanner can be transferred over the rails into the second room after the imaging is finished. The first advantage of this design is that no interference is experienced from the CT scanner during trauma resuscitation. Secondly, the design allows simultaneous use of the mirrored trauma rooms, with the sliding CT scanner accessible to both rooms. Both trauma resuscitating settings are equipped with a conventional X-ray installation and ultrasound. As a result of the AMC concept no further patient transport or transfers are necessary for obtaining a CT scan and all radiography can be performed in the trauma room. In addition, at any time during trauma resuscitation CT imaging can be performed.

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Endpoints: The primary outcome criterion used is the number of days spent outside the hospital in the first year following the trauma. This outcome is responsive to differences in mortality (no additional days outside hospital), to differences in hospital stay for the initial admission and to differences in readmission rate. The secondary outcome parameters include general health outcome at 6 and 12 months after the shockroom admission (using the EuroQol and HUI-3 questionnaires), morbidity and mortality during the first year following the trauma and various time intervals and process of care parameters of the initial admission (time to intervention, time to active bleed management, ICU and total hospital stay, etc.). Furthermore the radiation dosage is calculated in both strategies based on the actual number and type of radiological examinations related to the initial trauma performed in each patient during the first year. Study group: All acute trauma patients are eligible for inclusion for the REACT trial when transported by the ambulance or helicopter to the AMC or VUmc shockroom according to the current pre-hospital triage system based on: Injury mechanism, Revised Trauma Score (RTS) and presence of traumatic brain injury. These factors determine the level of care that has to be present in the facility to which patients are transported. The exclusion criteria for subsequent follow-up and analysis are patients younger than 16 years of age and patients who die during transport to the hospital. The start of the study was scheduled for 1-11-2005. Randomization:

Randomization

will

be

performed

at

the

“Meldkamer

Ambulancezorg Amsterdam” (MKA), the organization in charge of the coordination and distribution of ambulances and patients. Randomization will be performed using a computer program on a 1:1 basis with varying block sizes of 8, 12, and 16. Ambulance personnel will receive instructions according to the outcome of the randomization. Each eligible patient involved in a specific accident will be randomized. After each randomization, there is a pre-specified time interval of 1 hour in which eligible patients will be automatically transported to the other trauma center in order to minimize peak pressure in the study centers and guarantee optimal utilization of the two trauma centers. These patients are included in the

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trial, but are not formally randomized. In extreme cases, prehospital ambulance personnel can decide to waive the outcome of randomization, if they deem that the status of the patient requires the immediate attention of the closest hospital and death is imminent. Because the distance between the two hospitals is relatively short (8 km) no significant delay in treatment by patient transport is encountered regardless of the outcome of the randomization. Sample size: Based on the primary outcome criterion for both strategies, it is estimated that the common standard deviation is a total of 12 days. To detect an overall difference of 2 days in the number of days spent outside the hospital within the first year between the two strategies, 562 patients per group are needed for a two-sided significance level of 0.05 with a power of 0.80. Based on historical data, we expect around 500 shockroom patients to be admitted on a yearly basis at each of the two participating centers. Therefore, the total number of eligible patients per year would be 1000 patients. We expect that a quarter of these patients will be excluded for various reasons (age < 16 yrs, lost to follow up, etc.) leading to a total of 750 inclusions per year. Consequently, a 1½year period should be sufficient to include the necessary total number of 1124 (2 x 562) patients. Ethics and informed consent: The research protocol was primarily submitted to both the local Medical Ethics Committee (MEC) of the AMC and the VUmc to be reviewed. Both committees have been accredited to judge studies for the Central Committee on Research Involving Human Subjects and determined that the proposed study is not subject to the Medical Research Involving Human Subjects Act (WMO) and that therefore no further judgment is required for the study. Informed consents are not required from patients. Data analysis: The main Analyses of primary and secondary outcomes will be conducted for all randomized patients according to the result of the randomization (intention-to-treat). Additional Analyses include:

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(1) Per-protocol analysis excluding patients that are transported to a different hospital rather than the result of the assignment procedure. (2) Analysis of included patients treated either in the AMC or the VUmc independent of the randomization through the assignment procedure. We will conduct both unadjusted and adjusted Analyses. We will use gender, mechanism of trauma (sharp / blunt), initial Glasgow Coma Scale (GCS), RTS score and the presence of intubation to adjust for possible differences in severity of trauma between the AMC and VUmc patients. For subgroup analysis the following Analyses will be performed: Hemodynamically unstable patients (non-responders (SBP < 90) vs. transient responders (SBP > 90 with continuous fluid requirement)); Sharp vs. blunt trauma patients; Patients prehospitally treated by Mobile Medical Teams; Neurotrauma patients; Presence or absence of a seatbelt sign; Torso trauma vs. isolated extremity trauma; Intubated vs. spontaneously breathing. For final analysis standard statistical techniques will be used to compare the different outcomes between the two hospitals. Discussion The REACT trial is a multicentered, prospective randomized trial that evaluates the effect of the newly introduced Amsterdam Trauma Workflow concept on trauma care. The main goal of the Amsterdam Trauma Workflow concept is to minimize the total diagnostic work-up time of the initial trauma evaluation by integrating all diagnostic modalities in the trauma resuscitating room. This concept makes it possible to perform CT imaging earlier during the trauma evaluation without the need to transport the patient to the radiology department. This adjustment will likely result in a faster and improved workflow of trauma patients, that leads to a more complete diagnostic workup in the early phases of trauma resuscitation. This could potentially change therapeutic management options and eventually lead to a better outcome in severely injured trauma patients. The direct availability of CT scanning during the entire trauma resuscitation phase could mean that this could become available for even hemodynamically unstable patients

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A second advantage of this concept is the reduction in the number of patient manipulations, patient transfers and transports. Generally, these actions can have the aforementioned, adverse effects, which could expose the already critically ill patients to extra dangers. However, the introduction of the multifunctional radiolucent patient treatment table, that is suitable for resuscitation, conventional diagnostic imaging and CT scanning, minimize these actions and their additional risks. While the REACT study design enables us to describe the diagnostic and therapeutic procedures following initial CT scanning on an individual patient level, the REACT trial also gives us the opportunity to evaluate its effect on an institutional level. Because of the additional CT scanning capacity that was created by adding the sliding CT scanner that services the two mirrored trauma rooms, logistics for the radiology department will be influenced for both acute (trauma) patients and elective CT scanning. By potentially eliminating the need to reckon with unplanned acute CT imaging, the regular elective CT scans can be planned better and more efficient, possibly leading to a reduction of waiting times and waiting lists. Critically ill patient groups (i.e. trauma patients and patients with intracranial bleedings, acute aneurysms or abdomens, ICU patients, etc.) who need CT scanning can have their total diagnostic work-up completed in the shockroom before transport to their destination of treatment. In some cases the diagnostic work-up can even be completed simultaneously for two patients because of the mirrored shockroom design. Furthermore, the REACT study design enables us to describe in detail the diagnostic and therapeutic procedures following initial CT scanning of trauma patients in the shockroom or at the Radiology Department. We may be able to demonstrate a trade-off in the volume and cost of health care use between early detection of injuries and timely therapeutic management on one hand and late detection by additional diagnostic testing and subsequent therapies on the other. Another possible institutional effect might be that a shockroom CT scan may be used as an attractive alternative to other imaging procedures or to sequential diagnostic testing strategies in other patient groups (for instance stroke patients,

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patients with acute abdominal pain, etc), since it remains an all-inclusive multifocal diagnostic modality. As a consequence substitution of diagnostic modalities or changes in patient groups presenting for CT scanning may occur as a result of joint production. Finally, the total costs of realizing this concept are of substantial amount and therefore this shockroom design has to be assessed during the study period in a cost-effectiveness analysis. Conclusion The REACT trial is a prospective randomized multicenter trial that compares the effects of a new and revolutionary concept with a sliding CT scanner located in the trauma resuscitating room with a conventional setting, respectively a CT scanner located in the Radiology department.

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Abbreviations REACT: Randomized study of Early Assessment by CT scanning in Trauma patients, AMC: Academic Medical Center, VUmc: ‘Vrije Universiteit’ medical center CT: Computed Tomography, FAST: Focused Assessment with Sonography in Trauma, SBP: systolic blood pressure, HUI-3: Health Utility Index 3, MKA: Meldkamer Ambulancezorg Amsterdam Acknowledgment: ZONMW, grant number 3920.0005 We would like to thank our Advisory board for their input and efforts during the design, preparation and implementation of the trial.

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World Health Organization. WHO. http://www.who.int/topics/injuries/en/ 2008. World Health Organization. Regional Office for Europe; http://www.euro.who.int/violenceinjury ® Committee on Trauma: American College of Surgeons: Advanced Trauma Life Support (ATLS ); for Physicians, 7th Edition. Chicago: 1997. Holmes JF, Akkinepalli R: Computed tomography versus plain radiography to screen for cervical spine injury: a meta-analysis. J Trauma 2005, 58: 902-905. Demetriades D, Gomez H, Velmahos GC, Asensio JA, Murray J, Cornwell EE, III, Alo K, Berne TV: Routine helical computed tomographic evaluation of the mediastinum in high-risk blunt trauma patients. Arch Surg 1998, 133: 1084-1088. Exadaktylos AK, Sclabas G, Schmid SW, Schaller B, Zimmermann H: Do we really need routine computed tomographic scanning in the primary evaluation of blunt chest trauma in patients with "normal" chest radiograph? J Trauma 2001, 51: 1173-1176. Omert L, Yeaney WW, Protetch J: Efficacy of thoracic computerized tomography in blunt chest trauma. Am Surg 2001, 67: 660-664. Trupka A, Kierse R, Waydhas C, Nast-Kolb D, Blahs U, Schweiberer L, Pfeifer KJ: [Shock room diagnosis in polytrauma. Value of thoracic CT]. Unfallchirurg 1997, 100: 469-476. Fang JF, Wong YC, Lin BC, Hsu YP, Chen MF: Usefulness of multidetector computed tomography for the initial assessment of blunt abdominal trauma patients. World J Surg 2006, 30: 176-182. Korner M, Krotz MM, Degenhart C, Pfeifer KJ, Reiser MF, Linsenmaier U: Current Role of Emergency US in Patients with Major Trauma. Radiographics 2008, 28: 225-242.

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3 Randomized trial comparing the value of a CT scanner in the trauma room with a CT scanner in the radiology department; the REACT trial. TP Saltzherr PHP Fung Kon Jin FC Bakker KJ Ponsen JSK Luitse JF Giannakopoulos LFM Beenen CP Henny PMM Bossuyt MGW Dijkgraaf JB Reitsma JC Goslings

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Abstract Background: CT scanning of trauma patients when the scanner is located in the Radiology Department requires potentially dangerous and time-consuming patient transports and transfers. We hypothesised that a CT scanner located in the trauma room would improve patient outcome and workflow. Methods: In a randomized controlled trial with 1338 eligible patients we compared two infrastructural settings with regard to the CT scanner. In the intervention hospital the CT scanner was located in the trauma room. In the control hospital the scanner was located in the Radiology Department. Both hospitals are Level-1 trauma centers, geographically close, and responsible for the same area. Patients ≥16 years old triaged for evaluation in a Level-1 trauma center were randomly assigned to one of these hospitals at the time of transport. The primary outcome measure was the number of non-institutionalised days within the first year after randomization. Secondary measures were time from arrival to first CT image and number of patient transfers and transports. In preplanned subgroup analyses we evaluated the effects in multitrauma patients and in severe traumatic brain injury (TBI) patients. Results: In total, 1124 patients were included, of which 264 were multitrauma patients and 121 were TBI patients. The time from arrival to the first CT image was 13 minutes shorter in the intervention group (median 36.00 vs. 49.00, 95% CI: 10.05 to 15.44; p