Bartholomew J. Tortella

The value of intubating and paralyzing patients with suspected head injury in the emergency department.

One hundred consecutive trauma patients who underwent planned emergency intubation with muscle paralysis in the ED were studied to investigate the safety of these procedures and to determine their impact on the evaluation of patients with suspected head injury. Patients were intubated by either a surgeon (n = 47) or anesthesiologist (n = 53), and paralyzed with either vecuronium (n = 59) or succinylcholine (n = 41). Nasal intubation was used in 40 patients, oral in 57, and cricothyroidotomy in three. Ninety-four patients with suspected head injuries had a CT scan performed. Fifty-five (59%) had a positive scan and 15 required emergent neurosurgical intervention. Only two patients had lateral cervical spine roentgenograms before intubation; seven patients were eventually found to have cervical fractures. No patient suffered a neurologic deficit. One patient developed aspiration pneumonia following intubation. The three failed intubations occurred in patients with multiple facial fractures. We conclude that induced paralysis and intubation in the ED is safe, can facilitate the diagnostic workup, and may be a potentially life-saving maneuver in combative trauma patients.

Perioperative antibiotic use in high-risk penetrating Hollow viscus injury: A prospective randomized, double-blind, placebo-control trial of 24 hours versus 5 days

BACKGROUND The purpose of this study was to compare the safety and therapeutic efficacy of a 24-hour versus 5-day course of ampicillin/sulbactam for the prevention of postoperative infections in high-risk patients sustaining hollow viscus injury from penetrating abdominal trauma. METHODS A total of 317 patients from four Level I trauma centers with penetrating abdominal injuries and at least one hollow viscus perforation each received one preoperative and three postoperative doses of ampicillin/sulbactam 3 g intravenously. After receiving 24 hours of unblinded ampicillin/sulbactam, patients were then randomized into one of two groups. Group 1 received 4 additional days of blinded ampicillin/sulbactam (5 days total of antibiotic), and Group 2 received 4 days of placebo (24 hours of antibiotic). Patients were assessed postoperatively for occurrence of deep surgical-site infections (intra-abdominal abscess, fasciitis, and peritonitis) and superficial (wound) surgical-site infections. Development of nonsurgical-site infections (e.g., pneumonia, urinary tract infection, phlebitis, and cellulitis) was also recorded. Continuous variables were analyzed by analysis of variance and discrete variables by the Cochran-Mantel-Haenszel chi2 test. Multivariate logistic regression analyses were also performed to identify independent risk factors for postoperative infection. RESULTS A total of 159 patients were randomized into Group 1, and 158 patients were randomized into Group 2. The Injury Severity Score and penetrating abdominal trauma index were 18+/-8 and 21+/-13, respectively, for Group 1 and 18+/-9 and 20+/-15, respectively, for Group 2. A total of 162 (51%) patients sustained one or more colon injuries (82 in Group 1 and 80 in Group 2). There were 16 (10%) surgical-site infections in Group 1 and 13 (8%) surgical-site infections in Group 2 (p = 0.74). Group 1 patients experienced 17 (11%) nonsurgical-site infections, whereas Group 2 had 32 (20%) nonsurgical-site infections. This difference, however, was not statistically significant (p = 0.16). Only the total number of blood units transfused and the presence of a PATI score greater than or equal to 25 were found to be independently associated with the development of a postoperative surgical- and nonsurgical-site infections (p = 0.001 and p = 0.003, respectively). Of note, the presence of a colon injury was not found to be an independent risk factor (p = 0.11) for either surgical or nonsurgical site postoperative infection in our study. CONCLUSION High-risk patients with colon or other hollow viscus injuries from penetrating abdominal trauma are at no greater risk for surgical-site or nonsurgical-site infection when treated with only a 24-hour course of a broad-spectrum antibiotic.

Recombinant activated factor VII safety in trauma patients: results from the CONTROL trial.

BACKGROUND Safety data on recombinant activated factor VII (rFVIIa, NovoSeven; Novo Nordisk A/S, Bagsværd, Denmark) in actively hemorrhaging trauma patients are limited. We present detailed safety data from a large multicenter, randomized, placebo-controlled phase III study (the CONTROL trial). METHODS Data from 560 patients were analyzed. Subjects were monitored for adverse events (AEs) after rFVIIa or placebo administration. Incidences, timing, and presence of risk factors were reported by site investigators, supported by external study monitors and overseen by an independent Data Monitoring Committee. RESULTS There were no differences in overall mortality, organ system failure, or AEs, serious AEs, or medical events of special interest. Arterial and venous thromboembolic (TE) events and their risk factors were similar in both groups. The greatest risk factor for TE events was a chest injury requiring mechanical ventilation >3 days (86%). There were four site investigator-reported myocardial infarctions in the rFVIIa group of which only one met diagnostic criteria preestablished by the Data Monitoring Committee. There were no reported myocardial infarctions in the placebo group. Troponins were increased in 30% of all patients. The rate of acute respiratory distress syndrome was lower in the rFVIIa (3.0%) than in the placebo (7.2%) group (p = 0.022). CONCLUSIONS This represents the largest placebo-controlled dataset of rFVIIa use in trauma patients to date. In this prospective study of critically bleeding trauma patients, rFVIIa use was associated with an imbalance of investigator-reported Acute myocardial infarction/non-ST segment elevation myocardial infarction (AMI/NSTEMI), but was not associated with an increased risk for other AEs, including TE complications.

Deviations from evidence-based clinical management guidelines increase mortality in critically injured trauma patients*

Objectives:The effect of treatment guidelines on clinical outcomes in general and specifically for trauma patients has not been well-studied. We hypothesized that better compliance with guidelines would be associated with improved clinical outcomes. Design:Prospective, randomized, double-blinded, multicentered, placebo-controlled study of recombinant factor VII in severe trauma that utilized guidelines for damage control, transfusions, and mechanical ventilation. Vanderbilt Coordinating Center reviewed compliance in near real-time and reported deviations classified as minor, moderate, or major to investigators. Multivariate regression analysis measured the association between outcomes (30-day and 90-day mortality, development of multiple organ failure, ventilator-free days, renal failure-free days, and blood products transfused) and compliance with each guideline, as well as a composite assessment of overall compliance. Setting:One hundred hospitals in 26 countries. Patients:Blunt and/or penetrating trauma patients aged 18–70 yrs who had received 4–8 units of red blood cells for active torso and/or proximal lower extremity bleeding despite standard interventions. Measurements and Main Results:When assessed as composite end point, major deviations from guidelines were associated with significantly higher mortality at 30 and 90 days after injury and fewer renal failure-free days. Moderate deviations were associated with a significantly higher risk of multiple organ failure and fewer ventilator-free days. Moderate and major deviations from damage control and ventilation guidelines were also significantly associated with higher risk of death at days 30 and 90. Within the ventilation protocol, noncompliance with tidal volume and plateau pressure targets was associated with significantly higher mortality at days 30 and 90 and fewer ventilator-free days, whereas noncompliance with weaning guideline was only associated with significantly fewer ventilator-free days. Conclusions:In a clinical trial of trauma patients, higher compliance with guidelines for damage control, transfusion, and ventilation management is associated with lower mortality and improved outcomes.

CHALLENGES TO EFFECTIVE RESEARCH IN ACUTE TRAUMA RESUSCITATION: CONSENT AND ENDPOINTS

Selection of study endpoints is one of the most important decisions in the design of effective clinical trials. Late mortality (e.g., 28 days) is an unambiguous endpoint, accepted by regulatory agencies, but it is viewed as problematic among researchers in the study of resuscitation for acute trauma injury with hemorrhagic shock. In February 2008, physicians, ethicists, statisticians, and research scientists from the military, academia, industry, the Federal Drug Administration, and the National Heart Lung and Blood Institute gathered to discuss the obstacles confronting the trauma community in their efforts to improve patient outcomes. The primary meeting objective was to generate preliminary suggestions for a series of follow-up meetings that will develop consensus guidelines for the design of large multicenter clinical trials. Twenty short presentations and discussions, summarized here, outlined the groups concerns and suggestions. Successful and failed, completed or ongoing, clinical studies provided insight as to endpoints that may be of value for future trauma and shock studies. In addition to the importance of appropriate endpoints in study design, other related topics were discussed, including trauma epidemiology, patient enrollment and inclusion criteria, community consultation and the difficulty of obtaining informed consent in acute trauma research, and the inclusion of quality of life in composite endpoints. The consensus was that more discussion was needed and that consideration of new endpoints for clinical trials in emergency trauma research was a worthwhile and necessary goal.

Prospective, Randomized Trial of Epinephrine, Metaproterenol, and Both in the Prehospital Treatment of Asthma in the Adult Patient☆☆☆★

STUDY OBJECTIVE To compare the effectiveness and incidence of adverse reactions with three treatment regimens for asthma in adults in the prehospital setting. DESIGN Prospective, randomized clinical study. SETTING Inner-city emergency medical service system providing basic and advanced life support and transport to 14 urban area hospital emergency departments. PARTICIPANTS One hundred fifty-four adult asthmatic patients, 18 to 50 years old, who presented to paramedics with shortness of breath and wheezing. RESULTS Eligible patients were randomly assigned by the base station physician to one of three treatment groups: subcutaneous epinephrine, nebulized metaproterenol, or subcutaneous epinephrine and nebulized metaproterenol. Peak expiratory flow rate (PEFR), blood pressure, heart rate, and respiratory rate were measured before and after treatment in each patient. During a 9-month period (October 1992 through June 1993), 154 patients were enrolled in the study; 53 (34%) received epinephrine, 49 (32%) received metaproterenol, and 52 (34%) received both. There were no significant differences in patient demographics, initial vital signs, or pretreatment PEFR among the three groups. The mean difference between pretreatment and posttreatment PEFR was 73 L/min and did not significantly differ among the treatment groups. Significant changes in vital signs were seen in no treatment group. CONCLUSION Nebulized metaproterenol is as effective as subcutaneous epinephrine in the prehospital treatment of adult patients with acute asthma. The combination of these two treatments offered no additional clinical benefit in the patients we studied.

Analysis of 162 Colon Injuries in Patients with Penetrating Abdominal Trauma: Concomitant Stomach Injury Results in a Higher Rate of Infection

BACKGROUND Fecal contamination from colon injury has been thought to be the most significant factor for the development of surgical site infection (SSI) after trauma. However, there are increasing data to suggest that other factors may play a role in the development of postinjury infection in patients after colon injury. The purpose of this study was to determine the impact of gastric wounding on the development of SSI and nonsurgical site infection (NSSI) in patients with colon injury. METHODS Post hoc analysis was performed on data prospectively collected for 317 patients presenting with penetrating hollow viscus injury. One hundred sixty-two patients with colon injury were subdivided into one of three groups: patients with isolated colon wounds (C), patients with colon and stomach wounds with or without other organ injury (C+S), and patients with colon and other organ injury but no stomach injury (C-S) and assessed for the development of SSI and NSSI. Infection rates were also determined for patients who sustained isolated gastric injury (S) and gastric injury in combination with other injuries other than colon (S-C). Penetrating Abdominal Trauma Index, operative times, and transfusion were assessed. Discrete variables were analyzed by Cochran-Mantel-Haenszel chi2 test and Fishers exact test. Risk factor analysis was performed by multivariate logistic regression. RESULTS C+S patients had a higher rate of SSI infection (31%) than C patients (3.6%) (p=0.008) and C-S patients (13%) (p=0.021). Similarly, the incidence of NSSI was also significantly greater in the C+S group (37%) compared with the C patients (7.5%) (p=0.07) and the C-S patients (17%) (p=0.019). There was no difference in the rate of SSI or NSSI between the C and C-S groups (p=0.3 and p=0.24, respectively). The rate of SSI was significantly greater in the C+S patients when compared with the S-C patients (31% vs. 10%, p=0.008), but there was no statistical difference in the rate of NSSI in the C+S group and the S-C group (37% vs. 24%, p=0.15). CONCLUSION The addition of a gastric injury to a colon injury has a synergistic effect on the rate of postoperative infection.

Taking care of the good guys: A trauma center-based model of medical support for tactical law enforcement

The potential need for rapid medical intervention and access to a trauma center after major injury is crucial to the safety and success of SWAT team operations. This manuscript describes the genesis and development of a unique model for which advanced medical care is rendered by trained health care professionals within a regional trauma system in the support of a SWAT team. The model was developed jointly by the Newark, New Jersey, Division of the Federal Bureau of Investigation and The New Jersey Trauma Center-University Hospital, an academic, urban Level I trauma center. After the signing of a Memorandum of Understanding between the two agencies in 1995, the program became operational. The medical team is composed of physicians, nurses, and paramedics. Since inception, the medical team has provided medical support for 33 tactical missions and 99 training days. Ten patients were treated: 7 agents (syncope, fractured foot, blunt head/neck trauma, lacerations), 2 bystanders (chest pain, asthma), and 1 suspect (chest pain). The advantages of the Newark model in contrast to other programs of tactical medical support, are the operational activities of the team and the cost of the program was outlined.

The prehospital treatment of pediatric trauma

Prehospital pediatric trauma care is an important part of the EMS system. Review of 458 pediatric ALS trauma responses over two years treated in an urban, tiered ALS system revealed a male predominance. Violence (gunshot, stab, or assault) accounted for 46% of injuries, followed by vehicular accidents (occupant or pedestrian), with 35%. Important ALS resuscitation interventions were commonly performed enroute, with a high degree of success (IVs = 93%, intubation = 79%), and did not greatly prolong field times (9 min BLS vs 11.7 min ALS). ALS procedure success rates and field times reported here are lower than previously described.Benchmark standards for the prehospital care of pediatric trauma are proposed.

Disabling job injuries among urban EMS providers.

OBJECTIVE Nationwide data were collected concerning serious, disabling injuries requiring hospitalization (SDIH) or deaths among urban emergency medical services (EMS) providers. DESIGN AND SETTING A mail survey of EMS systems was conducted among the 200 most populated U.S. cities. PARTICIPANTS Participants were training and operations officers of urban EMS systems. MEASUREMENTS AND MAIN RESULTS Ninety forms (45%) were returned with 88 evaluable (44%). There were 81 SDIHs for a rate of one in 31,616 dispatches. No deaths were reported. Body parts most frequently injured were the hand (22%), head (19%), foot (16%), and eye (14%). Although 90% of fire-based EMS systems (fire-EMS) provided helmets, eye protection, safety shoes, and gloves, less than half (45%) of nonfire-EMS did so. Three (4%) SDIHs resulted from acts of violence. CONCLUSION Occupational injuries of EMS personnel are at a serious level. Fire-based EMS systems experienced a higher rate of hand SDIHs despite the provision of protective equipment. Few nonfire-EMS staff are provided with safety equipment, which may have resulted in a relatively high number of head and hand SDIHs. Fire-EMS medical directors need to take an active role in verifying that protective equipment is adequate and appropriate to allow the performance of field EMS duties without being too cumbersome. Medical directors of nonfire-EMS must be advocates for the provision of basic protective equipment aimed at mitigating SDIHs of EMS staff.