A voice-based digital assistant for intelligent prompting of evidence-based practices during ICU rounds.

OBJECTIVE: To evaluate the technical feasibility and potential value of a digital assistant that prompts intensive care unit (ICU) rounding teams to use evidence-based practices based on analysis of their real-time discussions. METHODS: We evaluated a novel voice-based digital assistant which audio records and processes the ICU care team's rounding discussions to determine which evidence-based practices are applicable to the patient but have yet to be addressed by the team. The system would then prompt the team to consider indicated but not yet delivered practices, thereby reducing cognitive burden compared to traditional rigid rounding checklists. In a retrospective analysis, we applied automatic transcription, natural language processing, and a rule-based expert system to generate personalized prompts for each patient in 106 audio-recorded ICU rounding discussions. To assess technical feasibility, we compared the system's prompts to those created by experienced critical care nurses who directly observed rounds. To assess potential value, we also compared the system's prompts to a hypothetical paper checklist containing all evidence-based practices. RESULTS: The positive predictive value, negative predictive value, true positive rate, and true negative rate of the system's prompts were 0.45 ± 0.06, 0.83 ± 0.04, 0.68 ± 0.07, and 0.66 ± 0.04, respectively. If implemented in lieu of a paper checklist, the system would generate 56% fewer prompts per patient, with 50%±17% greater precision. CONCLUSION: A voice-based digital assistant can reduce prompts per patient compared to traditional approaches for improving evidence uptake on ICU rounds. Additional work is needed to evaluate field performance and team acceptance.

Clindamycin Plus Vancomycin Versus Linezolid for Treatment of Necrotizing Soft Tissue Infection.

Background: Necrotizing soft tissue infections (NSTIs) are life-threatening infections. The aim of this study is to evaluate the safety of clindamycin plus vancomycin versus linezolid as empiric treatment of NSTIs. Methods: This was a retrospective, single-center, quasi-experimental study of patients admitted from 1 June 2018 to 30 June 2019 (preintervention) and 1 May 2020 to 15 October 2021 (postintervention). Patients who received surgical management within 24 hours of NSTI diagnosis and at least 1 dose of linezolid or clindamycin were included. The primary endpoint was death at 30 days. The secondary outcomes included rates of acute kidney injury (AKI) and Clostridioides difficile infection (CDI). Results: A total of 274 patients were identified by admission diagnosis code for NSTI or Fournier gangrene; 164 patients met the inclusion criteria. Sixty-two matched pairs were evaluated. There was no difference in rates of 30-day mortality (8.06% vs 6.45%; hazard ratio [HR], 1.67 [95% confidence interval {CI}, .32-10.73]; P = .65). There was no difference in CDI (6.45% vs 1.61%; HR, Infinite [Inf], [95% CI, .66-Inf]; P = .07) but more AKI in the preintervention group (9.68% vs 1.61%; HR, 6 [95% CI, .73-276]; P = .05). Conclusions: In this small, retrospective, single-center, quasi-experimental study, there was no difference in 30-day mortality in patients receiving treatment with clindamycin plus vancomycin versus linezolid in combination with standard gram-negative and anaerobic therapy and surgical debridement for the treatment of NSTIs. A composite outcome of death, AKI, or CDI within 30 days was more common in the clindamycin plus vancomycin group.

Increasing Quality and Frequency of Goals-of-Care Documentation in the Highest-Risk Surgical Candidates: One-Year Results of the Surgical Pause Program.

Patient values may be obscured when decisions are made under the circumstances of constrained time and limited counseling. The objective of this study was to determine if a multidisciplinary review aimed at ensuring goal-concordant treatment and perioperative risk assessment in high-risk orthopaedic trauma patients would increase the quality and frequency of goals-of-care documentation without increasing the rate of adverse events. Methods: We prospectively analyzed a longitudinal cohort of adult patients treated for traumatic orthopaedic injuries that were neither life- nor limb-threatening between January 1, 2020, and July 1, 2021. A rapid multidisciplinary review termed a "surgical pause" (SP) was available to those who were ≥80 years old, were nonambulatory or had minimal ambulation at baseline, and/or resided in a skilled nursing facility, as well as upon clinician request. Metrics analyzed include the proportion and quality of goals-of-care documentation, rate of return to the hospital, complications, length of stay, and mortality. Statistical analysis utilized the Kruskal-Wallis rank and Wilcoxon rank-sum tests for continuous variables and the likelihood-ratio chi-square test for categorical variables. Results: A total of 133 patients were either eligible for the SP or referred by a clinician. Compared with SP-eligible patients who did not undergo an SP, patients who underwent an SP more frequently had goals-of-care notes identified (92.4% versus 75.0%, p = 0.014) and recorded in the appropriate location (71.2% versus 27.5%, p < 0.001), and the notes were more often of high quality (77.3% versus 45.0%, p < 0.001). Mortality rates were nominally higher among SP patients, but these differences were not significant (10.6% versus 5.0%, 5.1% versus 0.0%, and 14.3% versus 7.9% for in-hospital, 30-day, and 90-day mortality, respectively; p > 0.08 for all). Conclusions: The pilot program indicated that an SP is a feasible and effective means of increasing the quality and frequency of goals-of-care documentation in high-risk operative candidates whose traumatic orthopaedic injuries are neither life- nor limb-threatening. This multidisciplinary program aims for goal-concordant treatment plans that minimize modifiable perioperative risks. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Improving delivery of low tidal volume ventilation in 10 ICUs.

Low tidal volume ventilation (LTVV) is standard of care for mechanically ventilated patients with acute respiratory distress syndrome and has been shown to improve outcomes in the general mechanically ventilated population. Despite these improved outcomes, in clinical practice the LTVV standard of care is often not met. We aimed to increase compliance with LTVV in mechanically ventilated patients in 10 intensive care units at 3 hospitals within the University of Pittsburgh School of Medicine Department of Critical Care Medicine. Four Plan-Do-Study-Act (PDSA) cycles were implemented to improve compliance with LTVV. Initial compliance rates of 40.6%-60.1% improved to 91%-96% by the end of the fourth PDSA cycle. The most impactful step in the intervention was providing education and giving responsibility of selecting the tidal volume to the respiratory therapist. The overall intervention resulted in improved compliance with LTVV that has been sustained for multiple years after our active PDSA cycles.

Initial absence of N20 waveforms from median nerve somatosensory evoked potentials in a patient with cardiac arrest and good outcomes.

A 34-year-old male was brought to the hospital with a chest gunshot wound. Pulseless upon arrival, blood pressure was absent for 10 minutes. A thoracotomy resulted in return of spontaneous circulation. On hospital day 5, with brainstem reflexes present, he was unresponsive to call or pain, exhibited generalized hyperreflexia and bilateral Babinskys. Median nerve somatosensory evoked potentials (mSSEPs) and brainstem auditory evoked potentials were obtained. International Federation of Clinical Neurophysiology recommendations for mSSEPs and brainstem auditory evoked potentials were followed. Despite absence of the N20 responses from cortical mSSEPs no withdrawal from care was agreed upon. After awaking on day 7, mSSEPs were repeated and present. The patient survived and was discharged with minor deficits. Bilateral absence of N20 responses from mSSEPs performed beyond 48 hours after resuscitation from cardiac arrest is highly associated with bad neurological outcomes. However, variation due to hypothermia, noisy signals, medications, and brain hypo-perfusion must be taken into account.

Bright environmental light improves the sleepiness of nightshift ICU nurses.

BACKGROUND: Shift work can disturb circadian homeostasis and result in fatigue, excessive sleepiness, and reduced quality of life. Light therapy has been shown to impart positive effects in night shift workers. We sought to determine whether or not prolonged exposure to bright light during a night shift reduces sleepiness and enhances psychomotor performance among ICU nurses. METHODS: This is a single-center randomized, crossover clinical trial at a surgical trauma ICU. ICU nurses working a night shift were exposed to a 10-h period of high illuminance (1500-2000 lx) white light compared to standard ambient fluorescent lighting of the hospital. They then completed the Stanford Sleepiness Scale and the Psychomotor Vigilance Test. The primary and secondary endpoints were analyzed using the paired t test. A p value <0.05 was considered significant. RESULTS: A total of 43 matched pairs completed both lighting exposures and were analyzed. When exposed to high illuminance lighting subjects experienced reduced sleepiness scores on the Stanford Sleepiness Scale than when exposed to standard hospital lighting: mean (sem) 2.6 (0.2) vs. 3.0 (0.2), p = 0.03. However, they committed more psychomotor errors: 2.3 (0.2) vs. 1.7 (0.2), p = 0.03. CONCLUSIONS: A bright lighting environment for ICU nurses working the night shift reduces sleepiness but increases the number of psychomotor errors. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03331822 . Retrospectively registered on 6 November 2017.

Effect of Ganciclovir on IL-6 Levels Among Cytomegalovirus-Seropositive Adults With Critical Illness: A Randomized Clinical Trial.

Importance: The role of cytomegalovirus (CMV) reactivation in mediating adverse clinical outcomes in nonimmunosuppressed adults with critical illness is unknown. Objective: To determine whether ganciclovir prophylaxis reduces plasma interleukin 6 (IL-6) levels in CMV-seropositive adults who are critically ill. Design, Setting, and Participants: Double-blind, placebo-controlled, randomized clinical trial (conducted March 10, 2011-April 29, 2016) with a follow-up of 180 days (November 10, 2016) that included 160 CMV-seropositive adults with either sepsis or trauma and respiratory failure at 14 university intensive care units (ICUs) across the United States. Interventions: Patients were randomized (1:1) to receive either intravenous ganciclovir (5 mg/kg twice daily for 5 days), followed by either intravenous ganciclovir or oral valganciclovir once daily until hospital discharge (n = 84) or to receive matching placebo (n = 76). Main Outcomes and Measures: The primary outcome was change in IL-6 level from day 1 to 14. Secondary outcomes were incidence of CMV reactivation in plasma, mechanical ventilation days, incidence of secondary bacteremia or fungemia, ICU length of stay, mortality, and ventilator-free days (VFDs) at 28 days. Results: Among 160 randomized patients (mean age, 57 years; women, 43%), 156 patients received 1or more dose(s) of study medication, and 132 patients (85%) completed the study. The mean change in plasma IL-6 levels between groups was -0.79 log10 units (-2.06 to 0.48) in the ganciclovir group and -0.79 log10 units (-2.14 to 0.56) in the placebo group (point estimate of difference, 0 [95% CI, -0.3 to 0.3]; P > .99). Among secondary outcomes, CMV reactivation in plasma was significantly lower in the ganciclovir group (12% [10 of 84 patients] vs 39% [28 of 72 patients]); absolute risk difference, -27 (95% CI, -40 to -14), P < .001. The ganciclovir group had more median VFDs in both the intention-to-treat (ITT) group and in the prespecified sepsis subgroup (ITT group: 23 days in ganciclovir group vs 20 days in the placebo group, P = .05; sepsis subgroup, 23 days in the ganciclovir group vs 20 days in the placebo group, P = .03). There were no significant differences between the ganciclovir and placebo groups in duration of mechanical ventilation (5 days for the ganciclovir group vs 6 days for the placebo group, P = .16), incidence of secondary bacteremia or fungemia (15% for the ganciclovir group vs 15% for the placebo group, P = .67), ICU length of stay (8 days for the ganciclovir group vs 8 days for the placebo group, P = .76), or mortality (12% for the ganciclovir group vs 15% for the placebo group, P = .54). Conclusions and Relevance: Among CMV-seropositive adults with critical illness due to sepsis or trauma, ganciclovir did not reduce IL-6 levels and the current study does not support routine clinical use of ganciclovir as a prophylactic agent in patients with sepsis. Additional research is necessary to determine the clinical efficacy and safety of CMV suppression in this setting. Trial Registration: clinicaltrials.gov Identifier: NCT01335932.

A retrospective analysis of the effectiveness of antipsychotics in the treatment of ICU delirium.

PURPOSE: Conflicting data exists on the efficacy of antipsychotics for treatment of intensive care unit (ICU) delirium. The purpose of this study was to compare time to delirium resolution for ICU patients who were managed with and without antipsychotics. MATERIALS AND METHODS: This retrospective cohort evaluation included patients admitted to 12 ICUs at 5 sites over 5 weeks diagnosed with delirium. The primary outcome was time to delirium resolution. Secondary outcomes included ICU length of stay (LOS), mortality, discharge disposition and delirium redevelopment. A Cox proportional hazards model explored the relationship between covariates including antipsychotics and time to delirium resolution. RESULTS: A total of 255 patients met inclusion criteria; 69 (27%) received antipsychotics. In the antipsychotic group, time to resolution of delirium was longer (Median: 36hours vs. 13hours, p<0.001) and ICU LOS was longer (Median: 5.9days vs. 3.8days, p=0.005), but there were no differences in mortality or discharge disposition. Patients who used antipsychotics (HR=0.512; 95% CI: 0.276-0.952) and received mechanical ventilation (HR=0.381; 95% CI: 0.217-0.669) had slower rate for time to delirium resolution. CONCLUSIONS: While the treatment of delirium with antipsychotics remains common, antipsychotics were not associated with a shorter time to resolution of delirium.

Effects of Physician-targeted Pay for Performance on Use of Spontaneous Breathing Trials in Mechanically Ventilated Patients.

RATIONALE: Pay for performance is an increasingly common quality improvement strategy despite the absence of robust supporting evidence. OBJECTIVES: To determine the impact of a financial incentive program rewarding physicians for the completion of daily spontaneous breathing trials (SBTs) in three academic hospitals. METHODS: We compared data from mechanically ventilated patients from 6 months before to 2 years after introduction of a financial incentive program that provided annual payments to critical care physicians contingent on unit-level SBT completion rates. We used Poisson regression to compare the frequency of days on which SBTs were completed among eligible patients and days on which patients were excluded from SBT eligibility among all mechanically ventilated patients. We used multivariate regression to compare risk-adjusted duration of mechanical ventilation and in-hospital mortality. MEASUREMENTS AND MAIN RESULTS: The cohort included 7,291 mechanically ventilated patients with 75,621 ventilator days. Baseline daily SBT rates were 96.8% (hospital A), 16.4% (hospital B), and 74.7% (hospital C). In hospital A, with the best baseline performance, there was no change in SBT rates, exclusion rates, or duration of mechanical ventilation across time periods. In hospitals B and C, with lower SBT completion rates at baseline, there was an increase in daily SBT completion rates and a concomitant increase in exclusions from eligibility. Duration of mechanical ventilation decreased in hospital C but not in hospital B. Mortality was unchanged for all hospitals. CONCLUSIONS: In hospitals with low baseline SBT completion, physician-targeted financial incentives were associated with increased SBT rates driven in part by increased exclusion rates, without consistent improvements in outcome.

Incidence and Etiology of Potentially Preventable ICU Readmissions.

OBJECTIVES: The rate of unplanned ICU readmissions is often considered a measure of hospital performance. However, the degree to which these readmissions are preventable and the causes of preventable readmissions are unknown, creating uncertainty about the feasibility and value of reducing ICU readmission rates. To inform this issue, we sought to determine the frequency and underlying causes of potentially preventable ICU readmissions. DESIGN: Retrospective cohort study. SETTING: Urban, academic medical center in the mid-Atlantic United States. PATIENTS: Adult patients discharged alive from their first ICU admission with an unplanned readmission within 48 hours of discharge. MEASUREMENTS AND MAIN RESULTS: Each patient's medical chart was reviewed by two independent investigators who rated each readmission's preventability according to standardized scale and assessed the etiology of both preventable and nonpreventable readmissions. We assessed concordance between raters using the κ statistic and resolved disagreements through iterative discussion. Of 136 readmissions in the final analysis, 16 (11.8%; 95% CI, 6.9-18.4) were considered preventable and 120 (88.2%; 95% CI, 81.5-93.1) were considered nonpreventable. Of nonpreventable readmissions, 67 were due to a new clinical problem and 53 were due to an existing clinical problem. Among preventable readmissions, six were attributable to system errors, six were attributable to management errors, two were attributable to procedural events, one was attributable to a diagnostic error, and one was attributable to a medication error. Compared to nonpreventable readmissions, preventable readmissions tended to have shorter index ICU lengths of stay (2 vs 3 d; p = 0.05) and a shorter duration of time on the ward prior to readmission (16.6 vs 23.6 hr; p = 0.05). CONCLUSIONS: The majority of early ICU readmissions are nonpreventable, raising important concerns about ICU readmission rates as a measure of hospital performance.

A Randomized Dose-Escalation Study of the Safety and Anti-Inflammatory Activity of the p38 Mitogen-Activated Protein Kinase Inhibitor Dilmapimod in Severe Trauma Subjects at Risk for Acute Respiratory Distress Syndrome.

OBJECTIVES: There are no current pharmacological therapies for the prevention or treatment of acute respiratory distress syndrome. Early dysregulated inflammation likely plays a role in acute respiratory distress syndrome development and possibly acute respiratory distress syndrome outcomes. p38 mitogen-activated protein kinase is central to the regulation of multiple inflammatory mediators implicated in acute organ dysfunction and is the target for a novel class of cytokine-suppressive anti-inflammatory drugs. In preclinical models, p38 inhibitors reduce lung injury following pancreatitis and burn injury. DESIGN: We conducted a phase IIa, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and tolerability of dilmapimod, a novel p38 mitogen-activated protein kinase inhibitor, in patients at risk for developing acute respiratory distress syndrome admitted with an Injury Severity Score more than 16, excluding head trauma. Enrolled patients received 4- or 24-hour IV dilmapimod infusions at different doses or placebo, daily for 3 days, in four separate cohorts. SETTING: Multicenter randomized clinical trial of large, academic trauma centers. MEASUREMENTS AND MAIN RESULTS: Seventy-seven patients were enrolled. Although adverse events were common in this critically ill population, dilmapimod was well tolerated, with no clinically relevant safety findings. Pharmacokinetic models indicated that the higher dose of 10 mg given as continuous infusion over 24 hours had the most favorable plasma concentration profile. Likewise, measures of soluble inflammatory markers including interleukin-6, C-reactive peptide, interleukin-8, and soluble tumor necrosis factor receptor 1 were most different between this dosing arm and placebo. Although the study was not specifically designed with acute respiratory distress syndrome as an outcome, the number of patients who developed acute respiratory distress syndrome was small (2/77). CONCLUSIONS: The novel p38 mitogen-activated protein kinase inhibitor dilmapimod appears well tolerated and may merit further evaluation for prevention of acute respiratory distress syndrome and other organ injury in larger clinical trials. Furthermore, results of this early-phase trial may aid in design of future studies aimed at prevention of acute respiratory distress syndrome and other organ injury.

Interleukin 6 and apolipoprotein E as predictors of acute brain dysfunction and survival in critical care patients.

BACKGROUND: Delirium occurs in up to 80% of intensive care patients and is associated with poor outcomes. The biological cause of delirium remains elusive. OBJECTIVES: To determine if delirium and recovery are associated with serum levels of interleukins and apolipoprotein E over time and with apolipoprotein E genotype. METHODS: The sample consisted of 77 patients with no previous cognitive deficits who required mechanical ventilation for 24 to 96 hours. Daily serum samples were obtained for enzyme-linked immunosorbent assay measurements of interleukins 6, 8, and 10 and apolipoprotein E. DNA extracted from blood was analyzed for apolipoprotein E genotyping. The Confusion Assessment Method for the Intensive Care Unit was administered daily on days 2 through 9. RESULTS: Among the 77 patients, 23% had no delirium, 46% experienced delirium, and 31% experienced coma. Additionally, 77% had delirium or coma (acute brain dysfunction), and compared with other patients, had fewer ventilator-free days (P = .03), longer stay (P = .04), higher care needs at discharge (P = .001), higher mortality (P = .02), and higher levels of interleukin 6 (P = .03), and the APOE*3/*3 apolipoprotein E genotype (P = .05). Serum levels of apolipoprotein E correlated with levels of interleukins 8 and 10. Patients with the E4 allele of apolipoprotein E had shorter duration of delirium (P = .02) and lower mortality (P = .03) than did patients without this allele. CONCLUSIONS: Apolipoprotein E plays a complex role in illness response and recovery in critically ill patients. The relationship between apolipoprotein E genotype and brain dysfunction and survival is unclear.

Impact of nurse-led remote screening and prompting for evidence-based practices in the ICU*.

OBJECTIVES: Evidence-based practices are not consistently applied in the ICU. We sought to determine if nurse-led remote screening and prompting for evidence-based practices using an electronic health record could impact ICU care delivery and outcomes in an academic medical center. DESIGN: Single-center, before-after evaluation of a quality improvement project. SETTING: Urban, academic medical center in the mid-Atlantic United States with eight subspecialty ICUs and 156 ICU beds. PATIENTS: Adult patients admitted to the ICU between January 1, 2011, and August 31, 2012. INTERVENTIONS: Beginning on July 25, 2011, trained ICU nurses screened all ICU patients for selected evidence-based practices on a daily basis. The screening was conducted from a remote office, facilitated by the electronic health record. Selected practices included compliance with a ventilator care bundle, assessment of appropriateness of indwelling venous and urinary catheters, and concordance between sedation orders and documented level of sedation. When gaps were observed, they were communicated to the point-of-care bedside nurse via telephone, page, or facsimile. MEASUREMENTS AND MAIN RESULTS: Fourteen thousand eight hundred twenty-three unique patients were admitted during the study period. We excluded 1,546 patients during a 2-month run-in period from July 1, 2011, to August 31, 2011, resulting in 4,339 patients in the 6-month preintervention period and 8,938 patients in the 12-month postintervention period. Compared with patients admitted in the preintervention period, patients admitted in the postintervention period were more likely to receive sedation interruption (incidence rate ratio, 1.57; 95% CI, 1.45-1.71) and a spontaneous breathing trial (incidence rate ratio, 1.24; 95% CI, 1.20-1.29). Hospital-acquired infection rates were not different between the two periods. Adjusting for patient characteristics and illness severity, patients in the postintervention period experienced shorter duration of mechanical ventilation (adjusted reduction, 0.61 d; 95% CI, 0.27-0.96; p < 0.001), shorter ICU length of stay (adjusted reduction, 0.22 d; 95% CI, 0.04-0.41; p = 0.02), and shorter hospital length of stay (adjusted reduction, 0.55 d; 95% CI, 0.15-0.93; p = 0.006). In-hospital mortality was unchanged (adjusted odds ratio, 0.96; 95% CI, 0.84-1.09; p = 0.54). The results were robust to tests for concurrent temporal trends and coincident interventions. CONCLUSIONS: A program by which nurses screened ICU patients for best practices from a remote location was associated with improvements in the quality of care and reductions in duration of mechanical ventilation and length of stay, but had no impact on mortality.

Harmonizing international trials of early goal-directed resuscitation for severe sepsis and septic shock: methodology of ProCESS, ARISE, and ProMISe.

PURPOSE: To describe and compare the design of three independent but collaborating multicenter trials of early goal-directed resuscitation for severe sepsis and septic shock. METHODS: We reviewed the three current trials, one each in the USA (ProCESS: protocolized care for early septic shock), Australasia (ARISE: Australasian resuscitation in sepsis evaluation), and the UK (ProMISe: protocolised management in sepsis). We used the 2010 CONSORT (consolidated standards of reporting trials) statement and the 2008 CONSORT extension for trials assessing non-pharmacologic treatments to describe and compare the underlying rationale, commonalities, and differences. RESULTS: All three trials conform to CONSORT guidelines, address the same fundamental questions, and share key design elements. Each trial is a patient-level, equal-randomized, parallel-group superiority trial that seeks to enroll emergency department patients with inclusion criteria that are consistent with the original early goal-directed therapy (EGDT) trial (suspected or confirmed infection, two or more systemic inflammatory response syndrome criteria, and refractory hypotension or elevated lactate), is powered to detect a 6­8 % absolute mortality reduction (hospital or 90-day), and uses trained teams to deliver EGDT. Design differences appear to primarily be driven by between-country variation in health care context. The main difference between the trials is the inclusion of a third, alternative resuscitation strategy arm in ProCESS. CONCLUSIONS: Harmonization of study design and methods between severe sepsis trials is feasible and may facilitate pooling of data on completion of the trials.

Multidisciplinary acute care research organization (MACRO): if you build it, they will come.

BACKGROUND: Clinical research will increasingly play a core role in the evolution and growth of acute care surgery program development across the country. What constitutes an efficient and effective clinical research infrastructure in the current fiscal and academic environment remains obscure. We sought to characterize the effects of implementation of a multidisciplinary acute care research organization (MACRO) at a busy tertiary referral university setting. METHODS: In 2008, to minimize redundancy and cost as well as to maximize existing resources promoting acute care research, MACRO was created, unifying clinical research infrastructure among the Departments of Critical Care Medicine, Emergency Medicine, and Surgery. During the periods 2008 to 2012, we performed a retrospective analysis and determined volume of clinical studies, patient enrollment for both observational and interventional trials, and staff growth since MACRO's origination and characterized changes over time. RESULTS: From 2008 to 2011, the volume of patients enrolled in clinical studies, which MACRO facilitates has significantly increased more than 300%. The percentage of interventional/observational trials has remained stable during the same period (50-60%). Staff has increased from 6 coordinators to 10, with an additional 15 research associates allowing 24/7 service. With this significant growth, MACRO has become financially self-sufficient, and additional outside departments now seek MACRO's services. CONCLUSION: Appropriate organization of acute care clinical research infrastructure minimizes redundancy and can promote sustainable, efficient growth in the current academic environment. Further studies are required to determine if similar models can be successful at other acute care surgery programs.

Use of a nasal bridle prevents accidental nasoenteral feeding tube removal.

Reinserting feeding tubes that are accidentally removed exposes patients to risk and consumes hospital resources. We were interested to know if using a bridle to secure tubes would be more effective than tape at preventing accidental tube removal. This was a quality improvement project with a before-and-after design. Between May 2007 and August 2007, we prospectively followed 90 tubes (50 tape, 40 bridle). Tubes were followed up daily until accidental tube removal, ICU discharge, or planned tube removal. Our primary endpoint was accidental tube removal. We compared the 2 groups on the following: (1) proportion of tubes accidentally removed; (2) rate of accidental tube removal (per 100 tube-days); and (3) Kaplan-Meier survival analysis. Survival analysis data were right-censored at ICU discharge or planned tube removal. There were no significant differences between groups in any demographics. The proportion of tubes accidentally removed was 36% (18 of 50) in the tape group and 10% (4 of 40) in the bridle group; P<.05. The rate of accidental tube removal (per 100 tube-days) was 6.4 (18 in 281 tube-days) in the tape group and 1.6 (4 in 248 tube-days) in the bridle group; P<.05. Survival analysis showed a significant difference between the groups with a log-rank test for equality of survivor function of P<.05. Using a bridle to secure feeding tubes significantly reduces the proportion and rate of accidental tube removal and results in increased tube survival by Kaplan-Meier analysis.

An FFP:PRBC transfusion ratio >/=1:1.5 is associated with a lower risk of mortality after massive transfusion.

OBJECTIVE: The detrimental effects of coagulopathy, hypothermia, and acidosis are well described as markers for mortality after traumatic hemorrhage. Recent military experience suggests that a high fresh frozen plasma (FFP):packed red blood cell (PRBC) transfusion ratio improves outcome; however, the appropriate ratio these transfusion products should be given remains to be established in a civilian trauma population. METHODS: Data were obtained from a multicenter prospective cohort study evaluating clinical outcomes in blunt injured adults with hemorrhagic shock. Those patients who required >/=8 units PRBCs within the first 12 hours postinjury were analyzed (n = 415). RESULTS: Patients who received transfusion products in >/=1:1.50 FFP:PRBC ratio (high F:P ratio, n = 102) versus <1:1.50 FFP:PRBC ratio (low F:P, n = 313) required significantly less blood transfusion at 24 hours (16 +/- 9 units vs. 22 +/- 17 units, p = 0.001). Crude mortality differences between the groups did not reach statistical significance (high F:P 28% vs. low F:P 35%, p = 0.202); however, there was a significant difference in early (24 hour) mortality (high F:P 3.9% vs. low F:P 12.8%, p = 0.012). Cox proportional hazard regression revealed that receiving a high F:P ratio was independently associated with 52% lower risk of mortality after adjusting for important confounders (HR 0.48, p = 0.002, 95% CI 0.3-0.8). A high F:P ratio was not associated with a higher risk of organ failure or nosocomial infection, however, was associated with almost a twofold higher risk of acute respiratory distress syndrome, after controlling for important confounders. CONCLUSIONS: In patients requiring >/=8 units of blood after serious blunt injury, an FFP:PRBC transfusion ratio >/=1:1.5 was associated with a significant lower risk of mortality but a higher risk of acute respiratory distress syndrome. The mortality risk reduction was most relevant to mortality within the first 48 hours from the time of injury. These results suggest that the mortality risk associated with an FFP:PRBC ratio <1:1.5 may occur early, possibly secondary to ongoing coagulopathy and hemorrhage. This analysis provides further justification for the prospective trial investigation into the optimal FFP:PRBC ratio required in massive transfusion practice.

MRI is unnecessary to clear the cervical spine in obtunded/comatose trauma patients: the four-year experience of a level I trauma center.

BACKGROUND: Cervical (C)-spine clearance protocols exist both to identify traumatic injury and to expedite rigid collar removal. Computed tomography (CT) of the C-spine in trauma patients facilitates the removal of immobilization collars in patients who are neurologically intact, and magnetic resonance imaging (MRI) has become an indispensable adjunct for evaluating trauma patients with neurologic deficits. Yet, the management of patients with impaired mental status who lack neurologic deficits attributable to the spinal cord remains controversial. C-spine MRI has been suggested and employed as an imaging modality to exclude occult C-spine instability in this population of patients. However, currently available data are inconclusive as to the necessity of MRI in the C-spine clearance of obtunded or comatose trauma patients with a normal CT. METHODS: The records of patients undergoing contemporaneous CT and MRI of the C-spine in a level I trauma center from January 2003 to December 2006 were retrospectively analyzed. From this group, patients admitted with a Glasgow Coma Scale score

Ability of pulse contour and esophageal Doppler to estimate rapid changes in stroke volume.

OBJECTIVE: Two technologies to acquire beat-to-beat stroke volume values exist, pulse contour analysis and esophageal Doppler monitoring. Pulse contour analysis assumes fixed aortic impedance. Esophageal Doppler assumes a constant proportional descending aortic flow and diameter. These assumptions may not be correct as arterial tone or myocardial contractility vary. We tested these relationships in the setting of rapidly changing stroke volumes and different cardiovascular states over a period of 10-15 cardiac cycles. DESIGN AND SETTING: In a university research facility we compared beat-to-beat changes in stroke volume as measure by aortic root flow probe or conductance catheter to pulse contour analysis and stroke distance as measured by esophageal Doppler. SUBJECTS: Five purpose-bred research hounds. INTERVENTIONS: To obtain a wide range of rapidly changing stroke volumes measurements were made during transient inferior vena cava occlusion. Data were gathered under baseline conditions and during norepinephrine, nitroprusside, and dobutamine infusions. MEASUREMENTS AND RESULTS: The pulse contour stroke volumes and esophageal Doppler stroke distance paralleled flow probe stroke volumes under all conditions (R(2)=0.89 for all measures). However, the absolute changes and proportional changes and the absolute values for both surrogate measures differed from absolute stroke volumes. Bland-Altman analysis showed no consistent bias or degree of precision across all animals under any given cardiovascular state. CONCLUSIONS: Both pulse contour stroke volumes and esophageal Doppler derived stroke distance estimates yield significant correlations with aortic root flow probe. However, the absolute values, absolute changes, or proportional changes may not reflect actual stroke volumes as cardiovascular state varies, making their use in estimating absolute changes in stroke volume potentially inaccurate.