Acute Respiratory Distress Syndrome (ARDS) after trauma: Improving incidence, but increasing mortality.

PURPOSE: Acute Respiratory Distress Syndrome (ARDS) is an infrequent, yet morbid inflammatory complication in injury victims. With the current project we sought to estimate trends in incidence, determine outcomes, and identify risk factors for ARDS and related mortality. MATERIALS & METHODS: The national Trauma Quality Improvement Program dataset (2010-2014) was queried. Demographics, injury characteristics and outcomes were compared between patients who developed ARDS and those who did not. Logistic regression models were fitted for the development of ARDS and mortality respectively, adjusting for relevant confounders. RESULTS: In the studied 808,195 TQIP patients, incidence of ARDS decreased over the study years (3-1.1%, p < 0.001), but related mortality increased (18.-21%, p = 0.001). ARDS patients spent an additional 14.7 ± 10.3 days in the hospital, 9.7 ± 7.9 in the ICU, and 6.6 ± 9.4 on mechanical ventilation (all p < 0.001). Older age, male gender, African American race increased risk for ARDS. Age, male gender, lower GCS and higher ISS also increased mortality risk among ARDS patients. Several pre-existing comorbidities including chronic alcohol use, diabetes, smoking, and respiratory disease also increased risk. CONCLUSION: Although the incidence of ARDS after trauma appears to be declining, mortality is on the rise.

Massive Transfusion Protocol Predictive Modeling in the Modern Electronic Medical Record.

Objectives: Integrate a predictive model for massive transfusion protocol (MTP) activation and delivery in the electronic medical record (EMR) using prospectively gathered data; externally validate the model and assess the accuracy and precision of the model over time. Background: The Emory model for predicting MTP using only four input variables was chosen to be integrated into our hospital's EMR to provide a real time clinical decision support tool. The continuous variable output allows for periodic re-calibration of the model to optimize sensitivity and specificity. Methods: Prospectively collected data from level 1 and 2 trauma activations were used to input heart rate, systolic blood pressure, base excess (BE) and mechanism of injury into the EMR-integrated model for predicting MTP activation and delivery. MTP delivery was defined as: 6 units of packed red blood cells/6 hours (MTP1) or 10 units in 24 hours (MTP2). The probability of MTP was reported in the EMR. ROC and PR curves were constructed at 6, 12, and 20 months to assess the adequacy of the model. Results: Data from 1162 patients were included. Areas under ROC for MTP activation, MTP1 and MTP2 delivery at 6, 12, and 20 months were 0.800, 0.821, and 0.831; 0.796, 0.861, and 0.879; and 0.809, 0.875, and 0.905 (all P < 0.001). The areas under the PR curves also improved, reaching values at 20 months of 0.371, 0.339, and 0.355 for MTP activation, MTP1 delivery, and MTP2 delivery. Conclusions: A predictive model for MTP activation and delivery was integrated into our EMR using prospectively collected data to externally validate the model. The model's performance improved over time. The ability to choose the cut-points of the ROC and PR curves due to the continuous variable output of probability of MTP allows one to optimize sensitivity or specificity.

Optimal timing of tracheostomy after trauma without associated head injury.

BACKGROUND: Controversy exists over optimal timing of tracheostomy in patients with respiratory failure after blunt trauma. The study aimed to determine whether the timing of tracheostomy affects mortality in this population. METHODS: The 2008-2011 National Trauma Data Bank was queried to identify blunt trauma patients without concomitant head injury who required tracheostomy for respiratory failure between hospital days 4 and 21. Restricted cubic spline analysis was performed to evaluate the relationship between tracheostomy timing and the odds of inhospital mortality. The cohort was stratified based on this analysis. Unadjusted characteristics and outcomes were compared. Multivariable logistic regression was used to evaluate the effect of tracheostomy timing on mortality after adjustment for age, gender, race, payor status, level of trauma center, injury severity score, presentation Glasgow coma scale, and thoracic and abdominal abbreviated injury score. RESULTS: There were 9662 patients included in the study. Restricted cubic spline analysis demonstrated a nonlinear relationship between timing of tracheostomy and mortality, with higher odds of mortality occurring with tracheostomy placement within 10 d of admission compared with later time points. The cohort was therefore stratified into early and delayed tracheostomy groups relative to this time point. The resulting groups contained 5402 (55.9%) and 4260 (44.1%) patients, respectively. After multivariable adjustment, the delayed tracheostomy group continued to have significantly reduced odds of mortality (Adjusted odds ratio, 0.82, 95% confidence interval, 0.71-0.95, C-statistic, 0.700). CONCLUSIONS: Among non-head injured blunt trauma patients with prolonged respiratory failure, tracheostomy placement within 10 d of admission may result in increased mortality compared with later time points.

Impact of specific postoperative complications on the outcomes of emergency general surgery patients.

BACKGROUND: The relative contribution of specific postoperative complications on mortality after emergency operations has not been previously described. Identifying specific contributors to postoperative mortality following acute care surgery will allow for significant improvement in the care of these patients. METHODS: Patients from the 2005 to 2011 American College of Surgeons' National Surgical Quality Improvement Program database who underwent emergency operation by a general surgeon for one of seven diagnoses (gallbladder disease, gastroduodenal ulcer disease, intestinal ischemia, intestinal obstruction, intestinal perforation, diverticulitis, and abdominal wall hernia) were analyzed. Postoperative complications (pneumonia, myocardial infarction, incisional surgical site infection, organ/space surgical site infection, thromboembolic process, urinary tract infection, stroke, or major bleeding) were chosen based on surgical outcome measures monitored by national quality improvement initiatives and regulatory bodies. Regression techniques were used to determine the independent association between these complications and 30-day mortality, after adjustment for an array of patient- and procedure-related variables. RESULTS: Emergency operations accounted for 14.6% of the approximately 1.2 million general surgery procedures that are included in American College of Surgeons' National Surgical Quality Improvement Program but for 53.5% of the 19,094 postoperative deaths. A total of 43,429 emergency general surgery patients were analyzed. Incisional surgical site infection had the highest incidence (6.7%). The second most common complication was pneumonia (5.7%). Stroke, major bleeding, myocardial infarction, and pneumonia exhibited the strongest associations with postoperative death. CONCLUSION: Given its disproportionate contribution to surgical mortality, emergency surgery represents an ideal focus for quality improvement. Of the potential postoperative targets for quality improvement, pneumonia, myocardial infarction, stroke, and major bleeding have the strongest associations with subsequent mortality. Since pneumonia is both relatively common after emergency surgery and strongly associated with postoperative death, it should receive priority as a target for surgical quality improvement initiatives. LEVEL OF EVIDENCE: Prognostic and epidemiologic study, level III.

Outcomes following splenectomy in patients with myeloid neoplasms.

BACKGROUND AND OBJECTIVES: Myeloid neoplasms are classified into five major categories. These patients may develop splenomegaly and require splenectomy to alleviate mechanical symptoms, to ameliorate transfusion-dependent cytopenias, or to enhance stem cell transplantation. The objective of this study was to determine which clinical variables significantly impacted morbidity, mortality, and survival in patients with myeloid neoplasms undergoing splenectomy, and to determine if operative outcomes have improved over time. METHODS: The records of all patients with myeloid neoplasms undergoing splenectomy from 1993 to 2010 were retrospectively reviewed. RESULTS: Eighty-nine patients (n = 89) underwent splenectomy for myeloid neoplasms. Over half of patients who had symptoms preoperatively had resolution of their symptoms post-splenectomy. The morbidity rate was 38%, with the most common complications being bleeding (14%) or infection (20%). Thirty-day mortality rate was 18% and median survival after splenectomy was 278 days. Decreased survival was associated with a diagnosis of myelodysplastic syndrome/myeloproliferative neoplasm, anemia, abnormal white blood cell count, and hypoalbuminemia. Patients who underwent stem cell transplantation did not show an increased risk for morbidity or mortality. CONCLUSIONS: Patients with myeloid neoplasms have a poor prognosis after splenectomy and the decision to operate is a difficult one, associated with high morbidity and mortality.

Laparoscopy is safe among patients with congestive heart failure undergoing general surgery procedures.

BACKGROUND: Over the past 2 decades, laparoscopy has been established as a superior technique in many general surgery procedures. Few studies, however, have examined the impact of the use of a laparoscopic approach in patients with symptomatic congestive heart failure (CHF). Because pneumoperitoneum has known effects on cardiopulmonary physiology, patients with CHF may be at increased risk. This study examines current trends in approaches to patients with CHF and effects on perioperative outcomes. METHODS: The 2005-2011 National Surgical Quality Improvement Program Participant User File was used to identify patients who underwent the following general surgery procedures: Appendectomy, segmental colectomy, small bowel resection, ventral hernia repair, and splenectomy. Included for analysis were those with newly diagnosed CHF or chronic CHF with new signs or symptoms. Trends of use of laparoscopy were assessed across procedure types. The primary endpoint was 30-day mortality. The independent effect of laparoscopy in CHF was estimated with a multiple logistic regression model. RESULTS: A total of 265,198 patients were included for analysis, of whom 2,219 were identified as having new or recently worsened CHF. Of these patients, there were 1,300 (58.6%) colectomies, 486 (21.9%) small bowel resections, 216 (9.7%) ventral hernia repairs, 141 (6.4%) appendectomies, and 76 (3.4%) splenectomies. Laparoscopy was used less frequently in patients with CHF compared with their non-CHF counterparts, particularly for nonelective procedures. Baseline characteristics were similar for laparoscopy versus open procedures with the notable exception of urgent/emergent case status (36.4% vs 71.3%; P < .001). After multivariable adjustment, laparoscopy seemed to have a protective effect against mortality (adjusted odds ratio, 0.45; P = .04), but no differences in other secondary endpoints. CONCLUSION: For patients with CHF, an open operative approach seems to be utilized more frequently in general surgery procedures, particularly in urgent/emergent cases. Despite these patterns and apparent preferences, laparoscopy seems to offer a safe alternative in appropriately selected patients. Because morbidity and mortality were considerable regardless of approach, further understanding of appropriate management in this population is necessary.

Vagotomy/drainage is superior to local oversew in patients who require emergency surgery for bleeding peptic ulcers.

OBJECTIVE: To compare early postoperative outcomes of patients undergoing different types of emergency procedures for bleeding or perforated gastroduodenal ulcers. BACKGROUND: Although definitive acid-reducing procedures are being used less frequently during emergency ulcer surgery, there is little published data to support this change in practice. METHODS: A retrospective analysis of data for patients from the 2005-2011 American College of Surgeons National Surgical Quality Improvement Program database who underwent emergency operation for bleeding or perforated peptic ulcer disease was performed to determine the association between surgical approach (local procedure alone, vagotomy/drainage, or vagotomy/gastric resection) and 30-day postoperative outcomes. Multivariable regression analysis was used to adjust for a number of patient-related factors. RESULTS: A total of 3611 patients undergoing emergency ulcer surgery (775 for bleeding, 2374 for perforation) were included for data analysis. Compared with patients undergoing local procedures alone, vagotomy/gastric resection was associated with significantly greater postoperative morbidity when performed for either ulcer perforation or bleeding. For patients with perforated ulcers, vagotomy/drainage produced similar outcomes as local procedures but required a significantly greater length of postoperative hospitalization. Conversely, vagotomy/drainage was associated with a significantly lower postoperative mortality rate than local ulcer oversew when performed for bleeding ulcers. CONCLUSIONS: Simple repair is the procedure of choice for patients requiring emergency surgery for perforated peptic ulcer disease. For patients requiring emergency operation for intractable ulcer bleeding, vagotomy/drainage is associated with lower postoperative mortality than with simple ulcer oversew.

Comparison of helicopter versus ground transport for the interfacility transport of isolated spinal injury.

BACKGROUND CONTEXT: The use and need of helicopter aeromedical transport systems (HEMSs) in health care today is based on the basic belief that early definitive care improves outcomes. Helicopter aeromedical transport system is perceived to be safer than ground transport (GT) for the interfacility transfer of patients who have sustained spinal injury because of the concern for deterioration of neurologic function if there is a delay in reaching a higher level of care. However, the use of HEMS is facing increasing public scrutiny because of its significantly greater cost and unique risk profile. PURPOSE: The aim of the study was to determine whether GT for interfacility transfer of patients with spinal injury resulted in less favorable clinical outcomes compared with HEMS. STUDY DESIGN/SETTING: Retrospective review of all patients transferred to a Level 1 trauma center. PATIENT SAMPLE: Patients identified from the State Trauma Registry who were initially seen at another hospital with an isolated diagnosis of injury to the spine and then transferred to a Level 1 trauma center over a 2-year period. OUTCOME MEASURES: Neurologic deterioration, disposition from the emergency department, in-hospital mortality, interfacility transfer time, hospital length of stay, nonroutine discharge, and radiographic evidence of worsening spinal injury. METHODS: Patients with International Classification of Diseases, Ninth Revision (ICD-9) codes for injury to the spine were selected and records were reviewed for demographics and injury details. All available spine radiographs were reviewed by an orthopedic surgeon blinded to clinical data and transport type. Chi-square and t tests and multivariate linear and logistic regression models were done using STATA version 10. RESULTS: A total of 274 spine injury patients were included in our analysis, 84 (31%) of whom were transported by HEMS and 190 (69%) by GT. None of the GT patients had any deterioration in neurologic examination nor any detectable alteration in the radiographic appearance of their spine injury attributable to the transportation process. Helicopter aeromedical transport system resulted in significantly less transfer time with an average time of 80 minutes compared with 112 minutes with GT (p<.001). Ultimate disposition included 175 (64%) patients discharged to home, 15 (5%) expired patients, and 84 (31%) discharged to extended care facilities. After adjusting for patient age and Injury Severity Score, the use of GT was not a significant predictor of in-hospital mortality (odds ratio, 1.4; 95% confidence interval, 0.3-5), hospital length of stay (11.2+1.3 vs. 9.5+0.8 days, p=.3), or nonroutine discharge (odds ratio, 1.1; 95% confidence interval, 0.5-2.2). CONCLUSIONS: Ground transport for interfacility transfer of patients with spinal injury appears to be safe and suitable for patients who lack other compelling reasons for HEMS. A prospective analysis of transportation mode in a larger cohort of patients is needed to verify our findings.

No need to wait: an analysis of the timing of cholecystectomy during admission for acute cholecystitis using the American College of Surgeons National Surgical Quality Improvement Program database.

BACKGROUND: The objective of our analysis was to determine the optimal timing of cholecystectomy during admission for acute cholecystitis. METHODS: All patients from the American College of Surgeons National Surgical Quality Improvement Program Participant User Files from 2005 through 2010 who underwent emergency cholecystectomy within 7 days of hospital admission for acute cholecystitis were included for analysis. The association between timing of cholecystectomy and postoperative outcomes was determined using multivariate logistic regression analyses after adjustment for patient demographics, acute and chronic comorbid medical conditions, preoperative sepsis classification, American Society of Anesthesiologists physical status classification, and preoperative liver function tests. RESULTS: A total of 5,268 patients were included for analysis. The timing of operation was day of admission for 49.7% of these patients, 1 day after admission for 33.4%, 2 days after admission for 9.5%, 3 days after admission for 3.9%, and 4 days to 7 days after admission for 3.6%. Multivariate logistic regression analyses revealed no significant association between timing of operation and 30-day postoperative mortality or overall morbidity. Patients who underwent operation later in the course of admission were more likely to require an open procedure and sustained significantly longer postoperative and overall lengths of hospitalization. Similar findings were demonstrated for a subgroup of patients who exhibited characteristics that placed them at higher risk for surgical intervention. CONCLUSION: Immediate cholecystectomy is preferred for patients who require hospitalization for acute cholecystitis. LEVEL OF EVIDENCE: Economic/decision analysis, level III.

Locoregional versus general anesthesia for open inguinal herniorrhaphy: a National Surgical Quality Improvement Program analysis.

Our objective was to study outcomes associated with open inguinal herniorrhaphy performed under locoregional (LR) versus general anesthesia (GA). National Surgical Quality Improvement Program (NSQIP) data from 2005 to 2009 was queried to capture patients undergoing initial unilateral inguinal herniorrhaphy. We excluded patients with incarcerated/strangulated hernia or those undergoing a concomitant procedure. Outcomes were anesthesia and operative times, postoperative admission, and 30-day morbidity. Using the entire NSQIP sample, forward stepwise multivariate regression analysis was used to compare outcomes between patients receiving LR versus GA after adjustment for patient demographics and comorbid diagnoses. Outcomes were also compared for a smaller subgroup of patients propensity-matched for receiving LR anesthesia. A total of 25,213 patients were analyzed (16,282 GA and 8,931 LR). Patients in the LR group had a higher incidence of comorbid illnesses and were more likely to have an American Society of Anesthesiologists classification ≥ 3. Multivariate analyses demonstrated that LR anesthetic is associated with shorter anesthetic and operative times and a lower hospital admission rate. Comparison using a propensity-matched cohort for undergoing LR anesthesia confirms that these patients had significantly shorter anesthesia (32 vs 38 min, P < 0.0001) and operative times (53.3 vs 57.2 min, P < 0.0001), as well as a significantly reduced rate of postoperative admission (5.9% vs 10.9%, P < 0.0001) and 30-day morbidity (0.9% vs 1.3%, P < 0.05). Our analysis of NSQIP suggests that, compared with general anesthesia, the locoregional technique is associated with shorter anesthesia and operative times, reduced need for postoperative hospital admission, and a small but significant reduction in postoperative morbidity.

A 9-Year retrospective review of antibiotic cycling in a surgical intensive care unit.

BACKGROUND: Six years after initiating a monthly antibiotic cycling protocol in the surgical intensive care unit (SICU), we retrospectively reviewed antibiogram-derived sensitivities of predominant gram-negative pathogens before and after antibiotic cycling. We also examined susceptibility patterns in the medical intensive care unit (MICU) where antibiotic cycling is not practiced. MATERIALS AND METHODS: Antibiotic cycling protocol was implemented in the SICU starting in 2003, with monthly rotation of piperacillin/tazobactam, imipenem/cilastin, and ceftazidime. SICU antibiogram data from positive clinical cultures for years 2000 and 2002 were included in the pre-cycling period, and those from 2004 to 2009 in the cycling period. RESULTS: Profiles of SICU pseudomonal isolates before (n = 116) and after (n = 205) implementing antibiotic cycling showed statistically significant improvements in susceptibility to ceftazidime (66% versus 81%; P = 0.003) and piperacillin/tazobactam (75% versus 85%; P = 0.021), while susceptibility to imipenem remained unaltered (70% in each case; P = 0.989). Susceptibility of E. coli isolates to piperacillin/tazobactam improved significantly (46% versus 83%; P < 0.0005), trend analysis showing this improvement to persist over the study period (P = 0.025). Similar findings were not observed in the MICU. Review of 2004-2009 antibiotic prescription practices showed monthly heterogeneity in the SICU, and a 2-fold higher prescribing of piperacillin/tazobactam in the MICU (P < 0.0001). CONCLUSIONS: Six years into antibiotic cycling, we found either steady or improved susceptibilities of clinically relevant gram-negative organisms in the SICU. How much of this effect is from cycling is unknown, but the antibiotic heterogeneity provided by this practice justifies its ongoing use.

The rapid impact on mortality rates of a dedicated care team including trauma and emergency physicians at an academic medical center.

BACKGROUND: Trauma center designation can result in improved patient outcomes after injuries. Whereas the presence of trauma teams has been associated with improved trauma patient outcomes, the specific components, including the role of emergency medicine (EM)-trained, board-certified emergency physicians, have not been defined. OBJECTIVE: To assess the outcomes of patients before and after the establishment of a dedicated trauma team that incorporated full-time EM-trained physicians with trauma specialists at a Level I trauma center at an academic institution. METHODS: Secondary analysis of prospectively collected trauma registry data was performed to compare mortality rates of all treated trauma patients before and after this intervention. RESULTS: The establishment of a dedicated specialty trauma team incorporating full-time EM presence including EM-trained, board-certified emergency physicians was associated with a reduction in overall non-DOA (dead on arrival) mortality rate from 6.0% to 4.1% from the time period preceding (1999-2000) to the time period after (2002-2003) this intervention (1.9% absolute reduction in mortality, 95% confidence interval [CI] 0.7%-3.0%). Among patients who were most severely injured (Injury Severity Score [ISS] ≥ 25), mortality rates decreased from 30.2% to 22.0% (8.3% absolute reduction in mortality, 95% CI 2.1%-14.4%). In comparison, there was minimal change in national mortality rates for patients with ISS ≥ 25 during the same time period (33% to 34%). CONCLUSIONS: The implementation of a dedicated full-time trauma team incorporating both trauma surgeons and EM-trained, board-certified or -eligible emergency physicians was associated with improved mortality rates in trauma patients treated at a Level I academic medical center, including those patients presenting with the most severe injuries.

Does intent matter? The medical and societal burden of self-inflicted injury.

BACKGROUND: The objective of our study was to assess the impact of injury intentionality on the outcomes and healthcare resource utilization of severely injured patients in the United States. METHODS: The National Trauma Data Bank for the years 2001 through 2006 was used for our analysis. Adult patients with an injury severity score >or=15 were divided into three groups based on injury intentionality: unintentional, assault, and self-inflicted. Demographic and injury characteristics, unadjusted and risk-adjusted mortality rates, and healthcare resource utilization variables were compared for these three groups using t tests, analysis of variance, and multivariable regression analyses where appropriate. Stata/SE version 9.2 was used for all statistical analyses. p values <0.05 were considered significant. RESULTS: A total of 138,589 patients were included for analysis. After adjustment for potentially confounding variables, self-inflicted injury remained a significant predictor of increased mortality (mortality 42.3%, adjusted odds ratio for death = 2.31, 95% confidence interval 1.97-2.71), and injury by assault a significant predictor of decreased mortality (mortality 18.3%, adjusted odds ratio for death = 0.83, 95% confidence interval 0.74-0.92), when compared with unintentional injury (mortality 15.1%). Patients surviving self-inflicted injury required longer intensive care unit stays and overall hospital stays than survivors of unintentional injury. CONCLUSIONS: Patients who are treated for self-inflicted injury have higher risk-adjusted mortality and utilize comparatively higher levels of healthcare resources than victims of assault or patients sustaining unintentional injury. The findings of our study emphasize the need for trauma center participation in the development and maintenance of aggressive primary and secondary suicide prevention programs.

Multiseptate gallbladder.

INTRODUCTION: Multiseptate gallbladder is a rare congenital condition that may be asymptomatic or may lead to symptoms consistent with biliary colic, even in the absence of cholelithiasis. DISCUSSION: We present the case of a 19-year-old female who underwent an extensive gastrointestinal workup before she was referred for cholecystectomy, which led to resolution of her symptoms. The distinct imaging features of this entity are presented.

A brief report: the use of high-frequency oscillatory ventilation for severe pulmonary contusion.

BACKGROUND: Severe pulmonary contusions are a common cause of acute respiratory distress syndrome (ARDS) and are associated with significant morbidity. High frequency oscillatory ventilation (HFOV) is a ventilatory mode that employs a lung protective strategy consistent with the ARDSNet low tidal volume ventilation strategy and may result in reduced morbidity. The objective of this report is to examine the impact of HFOV on blunt trauma patients with severe pulmonary contusions who failed or were at a high risk of failing conventional mechanical ventilation. METHODS: We undertook a retrospective chart review of all patients at our institution who received HFOV for severe pulmonary contusions. Patients were placed on HFOV when their mean airway pressure (mP(aw)) surpassed 30 cm H2O and their FIO2 was greater than 0.6. Baseline demographic data including injury severity score (ISS), length of time requiring HFOV, total ventilator days, and inhospital mortality were collected. Serial determinations of oxygenation index (OI) and the PaO2/FIO2 ratio (P/F) were made up to 72 hours after initiation of HFOV. A linear mixed model was used to analyze the slope (beta) of the regression line of P/F versus time and that of OI versus time. RESULTS: Seventeen patients were identified who underwent HFOV for ARDS due primarily to pulmonary contusions. Mean ISS was 36.6, mean APACHE II score was 21.7, and the mean time before initiation of HFOV was 2.0 days. P/F increased significantly after HFOV was initiated (beta = 12.1; 95% confidence interval 7.9 to 16.4, p < 0.001). OI significantly decreased after HFOV implementation (beta = -1.8; 95% confidence interval -2.3 to -1.3, p < 0.001). Mortality rate was 17.6%. CONCLUSIONS: The early use of HFOV appears to be safe and efficacious in blunt trauma patients sustaining pulmonary contusions, and results in a rapid improvement in OI and the P/F ratio.

Implementation of antibiotic rotation protocol improves antibiotic susceptibility profile in a surgical intensive care unit.

BACKGROUND: Antibiotic rotation has been proposed as a way to potentially reduce the development of antimicrobial resistant bacteria in intensive care units. We assessed the effect of an antibiotic rotation protocol on the antibiotic susceptibility profiles of three clinically relevant gram-negative microorganisms within our surgical intensive care unit (SICU). METHODS: Our SICU implemented an antibiotic rotation protocol in 2003. Four antibiotics (piperacillin/tazobactam, imipenem/cilastin, ceftazidime, and ciprofloxacin) were rotated as the primary antibiotic used to treat suspected gram-negative infections every month, with the four-drug cycle being repeated every 4 months. Antibiotic susceptibility data for three microorganisms (Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumoniae) were collected for the year before (2002) and the year after (2004) the implementation of the rotation protocol. Changes in antimicrobial susceptibility rates were analyzed for the three microorganisms. As a comparison, a similar analysis was conducted for microorganisms isolated from our medical intensive care unit, where no antibiotic rotation protocol was implemented. RESULTS: Implementation of an antibiotic rotation protocol in our SICU resulted in a significant increase in the percentage of P. aeruginosa isolates sensitive to ceftazidime (67% in 2002 vs. 92% in 2004, p = 0.002) and piperacillin/tazobactam (78% in 2002 vs. 92% in 2004, p = 0.043). Isolates from the medical intensive care unit did not demonstrate an increase in antimicrobial susceptibility. In fact, the susceptibility of E. coli to piperacillin/tazobactam decreased during this time period (p = 0.047). CONCLUSIONS: Implementation of an antibiotic rotation protocol in our SICU resulted in overall improvement in the antibiotic susceptibility profile of gram-negative microorganisms relative to our medical intensive care unit, where such a protocol was not used.

Ethical and regulatory challenges associated with the exception from informed consent requirements for emergency research: from experimental design to institutional review board approval.

Clinical research studies conducted in emergency settings under the waiver of consent provision outlined in federal regulations are uncommon, yet the importance of such research that may result in potentially lifesaving interventions is indisputable. Surgeons, as well as health care professionals in other disciplines of medicine, should be aware of the multiple challenges facing them if they contemplate conducting a research trial without the prospective informed consent of enrolled subjects. The challenges associated with conducting research studies using the exception from informed consent requirements for emergency research are numerous, beginning with ensuring an appropriate study design, understanding state and federal regulations that govern such emergency research studies, and continuing through a complicated and sometimes arduous institutional review board (IRB) process that is unique to these studies. This article will describe the challenges encountered when implementing the exception from informed consent requirements for emergency research and will provide surgeon researchers with an understanding of the ethical controversies surrounding such studies.