PubMed ID: 21107105
Ann Surg. 2010 Dec;252(6):959-65.
Authors: Bernard SA, Nguyen V, Cameron P, Masci K, Fitzgerald M, Cooper DJ, Walker T, Std BP, Myles P, Murray L, David, Taylor, Smith K, Patrick I, Edington J, Bacon A, Rosenfeld JV, Judson R.
Abstract:OBJECTIVE: To determine whether paramedic rapid sequence intubation in patients with severe traumatic brain injury (TBI) improves neurologic outcomes at 6 months compared with intubation in the hospital. BACKGROUND: Severe TBI is associated with a high rate of mortality and long-term morbidity. Comatose patients with TBI routinely undergo endo-tracheal intubation to protect the airway, prevent hypoxia, and control ventilation. In many places, paramedics perform intubation prior to hospital arrival. However, it is unknown whether this approach improves outcomes. METHODS: In a prospective, randomized, controlled trial, we assigned adults with severe TBI in an urban setting to either prehospital rapid sequence intubation by paramedics or transport to a hospital emergency department for intubation by physicians. The primary outcome measure was the median extended Glasgow Outcome Scale (GOSe) score at 6 months. Secondary end-points were favorable versus unfavorable outcome at 6 months, length of intensive care and hospital stay, and survival to hospital discharge. RESULTS: A total of 312 patients with severe TBI were randomly assigned to paramedic rapid sequence intubation or hospital intubation. The success rate for paramedic intubation was 97%. At 6 months, the median GOSe score was 5 (interquartile range, 1-6) in patients intubated by paramedics compared with 3 (interquartile range, 1-6) in the patients intubated at hospital (P = 0.28).The proportion of patients with favorable outcome (GOSe, 5-8) was 80 of 157 patients (51%) in the paramedic intubation group compared with 56 of 142 patients (39%) in the hospital intubation group (risk ratio, 1.28; 95% confidence interval, 1.00-1.64; P = 0.046). There were no differences in intensive care or hospital length of stay, or in survival to hospital discharge. CONCLUSIONS: In adults with severe TBI, prehospital rapid sequence intubation by paramedics increases the rate of favorable neurologic outcome at 6 months compared with intubation in the hospital.
Notes & Commentary:
This well designed, conducted and reported randomised controlled trial (RCT) of prehospital rapid sequence induction (RSI) of anaesthesia & intubation in traumatic brain injury is the first RCT of prehospital RSI of any reasonable quality in trauma. (See the 2009 Cochrane Review "Emergency intubation for acutely ill and injured patients"). Furthermore the researchers moved beyond mortality as the primary outcome to a more comprehensive assessment of outcome (dependency). They found no difference in hospital outcomes but a strong signal for "good neurological outcome" (normal to moderate disability) in the Prehospital RSI group.
Overall the study was well conducted. Subjects were block randomised by paramedic crew via sealed opaque envelopes. The study was conducted over nearly four years. There were a lot of exclusions - 1045 patients were screened but only 312 enrolled. Most exclusions were either because the patient was being transported by air, was less than 10 minutes from hospital or RSI skills were not available at scene.
As with all such studies there are many questions to answer. Despite the observed outcome differences, there was little difference in the 2 groups on hospital arrival, and in particular there was no difference in their PaO2, O2 saturations or PaCO2 measurements. What then was the benefit of prehospital RSI - does it avoid fluctuations in these variables or is it reducing spikes in intracranial pressure? The preshopital RSI patients statistically spent 12 minutes longer on scene, received approximately 500mls more crystalloid prehospitally, and were colder (by 0.6 degrees C). Is the observed effect due to the protective effects of this mild relative hypothermia (mean 35.0 degrees C).
Additionally there was overall benefit but it was not clear which subgroup had the most benefit from prehospital RSI. There was a trend to suggest that those age <60 received the most benefit. However the trial was really too small for these subgroup analyses and none of the reported subgroups showed worse outcomes with the study intervention. This study joins the list of recent studies showing that good quality clinical trials can be conducted in trauma care, even in the prehospital environment. There is really no longer any excuse for poor design, conduct or reporting of trauma trials. While a further large trial is warranted, this is strong support for prehospital RSI.
PubMed ID: 21178763
Ann Surg. 2010 Dec 20.[Epub]
Authors: Bulger EM, May S, Kerby JD, Emerson S, Stiell IG, Schreiber MA, Brasel KJ, Tisherman SA, Coimbra R, Rizoli S, Minei JP, Hata JS, Sopko G, Evans DC, Hoyt DB; for the ROC investigators.
Abstract:OBJECTIVE: To determine whether out-of-hospital administration of hypertonic fluids would improve survival after severe injury with hemorrhagic shock. BACKGROUND: Hypertonic fluids have potential benefit in the resuscitation of severely injured patients because of rapid restoration of tissue perfusion, with a smaller volume, and modulation of the inflammatory response, to reduce subsequent organ injury. METHODS: Multicenter, randomized, blinded clinical trial, May 2006 to August 2008, 114 emergency medical services agencies in North America within the Resuscitation Outcomes Consortium. Inclusion criteria: injured patients, age ≥ 15 years with hypovolemic shock (systolic blood pressure ≤ 70 mm Hg or systolic blood pressure 71-90 mm Hg with heart rate ≥ 108 beats per minute). Initial resuscitation fluid, 250 mL of either 7.5% saline per 6% dextran 70 (hypertonic saline/dextran, HSD), 7.5% saline (hypertonic saline, HS), or 0.9% saline (normal saline, NS) administered by out-of-hospital providers. Primary outcome was 28-day survival. On the recommendation of the data and safety monitoring board, the study was stopped early (23% of proposed sample size) for futility and potential safety concern. RESULTS: A total of 853 treated patients were enrolled, among whom 62% were with blunt trauma, 38% with penetrating. There was no difference in 28-day survival-HSD: 74.5% (0.1; 95% confidence interval [CI], -7.5 to 7.8); HS: 73.0% (-1.4; 95% CI, -8.7-6.0); and NS: 74.4%, P = 0.91. There was a higher mortality for the postrandomization subgroup of patients who did not receive blood transfusions in the first 24 hours, who received hypertonic fluids compared to NS [28-day mortality-HSD: 10% (5.2; 95% CI, 0.4-10.1); HS: 12.2% (7.4; 95% CI, 2.5-12.2); and NS: 4.8%, P < 0.01]. CONCLUSION: Among injured patients with hypovolemic shock, initial resuscitation fluid treatment with either HS or HSD compared with NS, did not result in superior 28-day survival. However, interpretation of these findings is limited by the early stopping of the trial. Clinical Trial Registration: ClinicalTrials.gov, NCT00316017].
Notes & Commentary:
This randomised controlled trial should be the final nail in the coffin for hypertonic saline in the resuscitation of haemorrhagic shock. The study was conducted by the Resuscitation Outcomes Consortium - a multicentre clinical trial network of trauma centres and their affiliated emergency medical services. The study was designed to enrol 3726 patients, but was stopped for futility and the possibility of harm in terms of increased mortality in the hypertonic saline sybgroups.
Overall there was no difference in 28-day mortality or any of the reported outcomes. Mortality was 25.6% for the NS group versus 27% for HS and 25.5% for HSD:
The reason for early stopping of the trial is rather tenous. Stopping a trial for "futility" lays a trial open to the vagaries of randomness and assumes that what happened in the enrolled patients was fully representative of the final study cohort. The trial was also stopped because of concern s about possibly increased mortality in a group of patients who did not receive blood transfusions. This was an observation made on a sub-group of patients that had not been identifed a priori and had not reached statistical significance. This is also a post-randomisation variable that has clear potential for interaction with the study intervention. Much of the paper is given over to the post-hoc analysis of this subgroup and presents lots of conjecture but few real conclusions.
The authors also state that the 'The DSMB [data and safety monitoring board] also noted that the setting of an exception to informed consent study warranted an abundance of caution'. Personally I think this a lousy statement that does a disservice to those subjects who did participate in the trial and is contrary to the fundamental ethics of clinical trials. Emergency consent procedures have been developed around the world to allow the study of acute diseases. Clinical trials should be designed and conducted optimally within these structures. It is not appropriate to skew robust clinical trial methodolgy and the interpretation of clinical trial data because of the ethical setting - in fact it is borderline unethical to do so (IMHO).
Anyway - fundamentally the trial is negative and it is unlikely that a large treatment effect was missed due to the early termination. There is no clinical advantage to the resuscitation of haemorrhagic shock with hypertonic saline. Whether this has any bearing on the role of HS versus mannitol in the setting of traumatic brain injury with or without hypovolaemia is unclear.
PubMed ID: 21079092
Arch Surg. 2010 Nov;145(11):1048-53
Authors: Bowman SM, Bulger E, Sharar SR, Maham SA, Smith SD
Abstract:BACKGROUND: Although nonoperative management is the standard of care for hemodynamically stable children with blunt splenic trauma, significant variation in practice exists. Little attention has been given to physician factors associated with management differences. DESIGN: Nationally representative mail survey conducted in June 2008. SETTING: United States. PARTICIPANTS: Ten percent random sample of active, dues-paying fellows in the American College of Surgeons. MAIN OUTCOME MEASURES: Knowledge, attitudes, and beliefs toward pediatric splenic injury management, including the role of clinical practice guidelines. RESULTS: Almost all of the 375 responding surgeons (97.4%) agreed that surgical intervention is not immediately necessary for hemodynamically stable children. However, surgeons reported significant disagreement regarding whether blood should be administered before operative intervention for hemodynamically unstable children and whether explorative surgery is needed for stable patients with evidence of contrast extravasation on computed tomography. Only 18.7% of surgeons reported being very familiar with the clinical practice guidelines for the management of pediatric blunt splenic trauma from either the Eastern Association for the Surgery of Trauma or the American Pediatric Surgical Association. Surgeons who were very familiar with either guideline were significantly more likely to rate the guidelines as beneficial (90.0% vs 72.8%, P = .002). CONCLUSIONS: General surgeons reported varying degrees of familiarity with and use of clinical practice guidelines for pediatric splenic injury management. Limited pediatric experience and lack of pediatric hospital resources may limit more widespread adoption of nonoperative management. Targeted educational interventions may help increase surgeon knowledge of guidelines and best practices.
Notes & Commentary:
I'm not normally a big fan of surveys of practice but it can be a useful exercise in highlighting deficiencies or discrepancies in care. This is a case in point, where there are fundamental issues with the management of paediatric trauma. Serious paediatric trauma is uncommon and most surgeons outside of paeditric trauma centres will see very few cases in their lifetime. In a letter we wrote to the Annals of the Royal College of Surgeons of England we estimated that the average general surgeon in the UK would perform a paediatric splenectomy once every 25 years (and that as before the reduction of working hours!) (PMID: 12831498).
This study shows how low paediatric trauma is on the radar of general surgeons. There is widespread understanding that the majority of paediatric splenic injuries can be managed non-operatively (over 90% in some series). However this does not translate into ALL spleen injuries can be managed non-operatively. Identifying the child with a spleen injury who is not responding to fluid resuscitation and making the decision to operate is extremely difficult when the condition is rare and the intervention even rarer - but these are the children whose lives can be saved by relatively simple immediate surgery.
Much has been written recently on the non-operative management of spleen injuries. What needs to be focused on is operative management and specifically decision making in paediatric trauma.
PubMed ID: 21112053
Injury. 2010 Nov 25. [Epub ahead of print]
Authors: Floccard B, Rugeri L, Faure A, Denis MS, Boyle EM, Peguet O, Levrat A, Guillaume C, Marcotte G, Vulliez A, Hautin E, David JS, Négrier C, Allaouchiche B.
Abstract:PURPOSE: Amongst trauma patients, early coagulopathy is common on hospital admission. No studies have evaluated the initial coagulation status in the pre-hospital setting. We hypothesise that the coagulopathic process begins at the time of trauma. We studied the on-scene and on hospital arrival coagulation profile of trauma patients. METHODS: Prospective, observational study investigating the on-scene coagulation profile and its time course. We studied 45 patients at the scene of the accident, before fluid administration, and on hospital admission and classified their coagulopathy using the International Society on Thrombosis and Haemostasis score during a 2-month period. Prothrombin time, activated partial thromboplastin time, fibrinogen concentration, factors II, V and VII activity, fibrin degradation products, antithrombin and protein C activities, platelet counts and base deficit were measured. RESULTS: The median injury severity score was 25 (13-35). On-scene, coagulation status was abnormal in 56% of patients. Protein C activities were decreased in the trauma-associated coagulopathy group (p=.02). Drops in protein C activities were associated with changes in activated partial thromboplastin time, prothrombin time, fibrinogen concentration, factor V and antithrombin activities. Only factor V levels decreased significantly with the severity of the trauma. On hospital admission, coagulation status was abnormal in 60% of patients. The on-scene coagulopathy was spontaneously normalised only in 2 patients whereas others had the same or a poorer coagulopathy status. All parameters of coagulation were significantly abnormal comparing to the on-scene phase. Decreases in protein C activities were related to the coagulation status (p<.0001) and changes in other coagulation parameters. Patients with base deficit ≤-6mmol/L had changes in antithrombin, factor V and protein C activities but no significant coagulopathy. CONCLUSION: Coagulopathy occurs very early after injury, before fluid administration, at the site of accident. Coagulation and fibrinolytic systems are activated early. The incidence of coagulopathy is high and its severity is related to the injury and not to hypoperfusion.
Notes & Commentary:
Acute Traumatic Coagulopathy (ATC) has been described as present in 10-25% of trauma patients on arrival in the emergency department. This is the first on-scene study of ATC and identifies a very high incidence of 56% when measured in 45 patients. These were patients managed by SAMU and a more severely injured group of patients (average ISS 25) but this remains a very high incidence. UNfortunately the authors use a DIC score to define ATC. ATC is not a DIC-type coagulopathy and ATC was not included in the development of the ISTH DIC score. Nevertheless ATC clearly develops very soon after injury (25 minutes on average in this study) as shown by a fall in Protein C and Factor V levels as we have previously shown (PMID:18212647). This study adds to the evidence that ATC is endogenous as this was before significant dilution or other iatrogenic interntion. The speed at which dysfunction of coagulation and inflammation develops continues to surprise and challenge pre-existing conceptions of the pathophysiology of trauma.
The National Audit Office has just released a report on the provision of major trauma services in the UK. The report contains no new surprises - similar reports from independent bodies have been released regularly since the Ormond-Clarke report in 1961. The NAO report does mandate a hearing in the parliament Public Accounts Committee however and it is expected that some action must follow.
Some snippets from the report:
"We estimate that there are at least 20,000 cases of major trauma each year in England resulting in 5,400 deaths and many others resulting in permanent disabilities requiring long-term care. There are around a further 28,000 cases which, although not meeting the precise definition of major trauma, would be cared for in the same way. [...] We estimate that major trauma costs the NHS between £0.3 and £0.4 billion a year in immediate treatment. The cost of any subsequent hospital treatments, rehabilitation, home care support, or informal carer costs are unknown. We estimate that the annual lost economic output as a result of major trauma is between £3.3 billion and £3.7 billion."
"Despite repeated reports identifying poor practice, the Department and NHS trusts have taken very little action to improve major trauma care. Deficiencies in major trauma care were identified by the Royal College of Surgeons in 1988, but there has been little progress since. In 2007, a report by the National Confidential Enquiry into Patient Outcome and Death (NCEPOD) concluded that 60 per cent of major trauma patients received a standard of care that was ‘less than good practice’.
"As major trauma is a relatively small part of the work of an emergency department, optimal care cannot be delivered cost-effectively by all hospitals. People who have suffered major trauma often have multiple injuries which need to be treated by different surgical specialties. [...] The delivery of major trauma care lacks coordination and can lead to 11 unnecessary delays in diagnosis, treatment and surgery. There are currently no formal protocols for determining where people should be taken for treatment, nor a formal system for transferring patients between hospitals."
"The availability of rehabilitation varies widely across the country, and 14 services have not developed on the basis of geographical need. Although rehabilitation may help to reduce length of stay, minimise hospital readmissions, and reduce the use of NHS resources following the initial period of hospitalisation, it has not been considered to any great degree by strategic health authorities in their reviews of major trauma services. There is a widely perceived lack of capacity for the specialist rehabilitation of major trauma patients, but with little hard evidence about what services are currently available and how well they are arranged to meet patient needs, it is difficult to reach a conclusion on this."
The London Trauma System goes live on 1st April 2010. There is a national process in place at the moment, although there are no deadlines or deliverables for this yet. While the London system is probably secure politically, the national process is at the mercy of a change in government and policy. Both systems are at risk if some key elements of the system are not addressed, especially the financial structure for trauma and the woeful state of rehabilitation services.
The full report and executive summary are available from the National Audit Office website. The BBC has radio and TV coverage of the release, including some footage filmed with us at the Royal London Hospital.
PubMed ID: 20068485
J Trauma. 2010 Jan 9. [Epub ahead of print]
Authors: Glance LG, Osler TM, Dick AW, Mukamel DB, Meredith W.
Abstract:BACKGROUND:: This report describes a project funded by the Agency for Healthcare Research and Quality to evaluate the impact of providing hospitals with nonpublic report cards on trauma outcomes. The Survival Measurement and Reporting Trial for Trauma explores the feasibility of using the National Trauma Data Bank as a platform for measuring and improving trauma outcomes. METHODS:: We identified a cohort of 125 hospitals in the National Trauma Data Bank with annual hospital volumes of 250 or more trauma cases meeting specific minimum criteria for data quality. The performance of hospitals in this cohort was evaluated using hierarchical logistic regression model. The effect of each hospital on trauma mortality was captured by a shrinkage coefficient, which is exponentiated to yield an adjusted odds ratio. This adjusted odds ratio represents the likelihood that a trauma patient treated at a specific hospital is more or less likely to die compared with a patient treated at an "average" hospital. RESULTS:: The initial hospital cohort includes 125 hospitals and 157,045 patients admitted in 2006. Most hospitals are either level I (36%) or level II (34%) trauma centers. Patients admitted to the worst-performing hospitals were at least 50% more likely to die than patients admitted to the average hospital, after adjusting for injury severity. CONCLUSION: The initial findings of this trial suggest that there is significant variability in trauma mortality across centers caring for injured patients after adjusting for differences in patient casemix. This variation in risk-adjusted mortality presents an opportunity for improvement. The Survival Measurement and Reporting Trial for Trauma study is designed to test the hypothesis that nonpublic report cards can lead to improved population mortality for injured patients. The results of this study may have substantial implications in the future design and implementation of a national effort to report and improve trauma outcomes in the United States.
Notes & Commentary:
This wide variability in outcomes at different hospitals is mirrored by other studies of injury care at individual institutions. The Trauma Audit & Research Network iregularly collates this data for hospitals in England & Wales:
What is more concerning is that, unlike the UK figures, the hospitals in this study are mainly trauma centres and therefore should be meeting designated performance standards in order to maintain their trauma centre status. It'd be interesting to see if there is similar variability between hospitals accredited under American College of Surgeons criteria for designation, rather than state or local criteria.
There are problems with this form of modelling. Hospital's whose case mix varies from the national average may have skewed results (positively or negatively). Additionally the relationship between statistical modelling of unexpected deaths or survivors has not yet been validated against assessment of the quality of clinical care.
Interesting also is that these are non-reported data. TARN data is available to the general public, so you can see how your local hospital performs compared to the national average. Here's part of our page from the Royal London Hospital.
There's nothing like public opinion to make hospitals up their game.
Just put the programme to bed on this year's Trauma Transfusion & Haemostasis Scientific Symposium. There's a really *really* strong speaker line-up and it should be a fantastic day. Speakers have been told to bring their latest data and most current thinking on their topics and we'll be looking at current knowledge as well as looking into the near future at things like artificial platelets and stem-cell derived blood transfusions.
Full programme is here: http://www.trauma.org/index.php/main/article/951/
As always, the London Trauma Conference (of which this is a part) is at: www.londontraumaconference.com where you can book online.
Videos of last years Trauma Transfusion & Coagulopathy masterclass are online of TRAUMA.ORG: http://www.trauma.org/index.php/main/article/713/
See you there!
So, just in time for this year's London Trauma Conference, we've uploaded the presentations from the 'Trauma Massive Transfusion & Coagulopathy State of the Art Symposium' held at the London Trauma Conference in 2008. This set of lectures presents an overview of the current state of knowledge in the exploding field of Trauma Induced Coagulopathy (TIC) and transfusion practice. At this year's conference we'll be holding a complementary Scientific Symposium on Trauma Haemostasis & Transfusion. The programme is just being finalized and will be available in the next few days. Meanwhile, enjoy the presentations from last year - and TRAUMA.ORG's new video channel on Vimeo.
PubMed ID: 19680160
J Trauma. 2009 Aug 12.
Authors: Teixeira PG, Inaba K, Oncel D, Dubose J, Chan L, Rhee P, Salim A, Browder T, Brown C, Demetriades D.
Abstract:OBJECTIVE:: Because of its rarity and high rate of mortality, traumatic blunt cardiac rupture (BCR) has been poorly studied. The objective of this study was to use the National Trauma Data Bank to review the epidemiology and outcomes associated with traumatic BCR. METHODS:: After approved by the institutional review board, the National Trauma Data Bank (version 5.0) was queried for all BCR occurring between 2000 and 2005. Demographics, clinical injury data, interventions, and outcomes were abstracted for each patient. Statistical analysis was performed using an unpaired Student's t test or Mann-Whitney U test to compare means and chi analysis to compare proportions. Stepwise logistic regression analysis was performed to identify independent predictors of inhospital mortality. RESULTS:: Of 811,531 blunt trauma patients, 366 (0.045%) had a BCR of which 334 were available for analysis, with the mean age of 45 years, 65% were men, and their mean Injury Severity Score was 58 +/- 19. The most common mechanism of injury was motor vehicle collision (73%), followed by pedestrian struck by auto (16%), and falls from height (8%). Twenty-one patients (6%) died on arrival and 140 (42%) died in the emergency room. The overall mortality for patients arriving alive to hospital was 89%. Of the patients surviving to operation, 42% survived >24 hours of which 87% were discharged. Survivors were significantly younger (39 vs. 46 years, p = 0.04), had a lower Injury Severity Score (47 vs. 56, p = 0.02), higher Glasgow Coma Scale (10 vs. 6, p < 0.001), and were more likely to present with an systolic blood pressure >/=90 mm Hg (p = 0.01). Nevertheless, none of these factors was found to be an independent risk factor for mortality. CONCLUSION:: BCR is an exceedingly rare injury, occurring in 1 of 2400 blunt trauma patients. In patients arriving alive to hospital, traumatic BCR is associated with a high mortality rate, however, is not uniformly fatal.
Notes & Commentary:
Coming shortly after our description of the patient with cardiac herniation following blunt trauma is this review of the National Trauma DataBank from the LA County group. Of course this is the tip of the iceberg as most patients will die at scene, but there's a surprisingly low (42%) mortality in the emergency department, suggesting that a significant proportion of these patients should be salvageable if identified early and managed appropriately.