Consequences of anemia in geriatric hip fractures: how low is too low?

Background: The transfusion threshold for low hemoglobin (Hgb) in geriatric patients with hip fractures is widely debated. In certain populations, low Hgb is associated with poor outcomes. Our objective was to evaluate the relationship between lowest Hgb and outcome to identify the Hgb threshold where poor outcomes were more prevalent. Methods: This retrospective cohort study included consecutive patients with hip fractures, aged ≥60 years, evaluated at two level 1 trauma centers from 2018 to 2021. Patients who did not undergo operative fixation or had a length of stay <1 day were excluded. The primary endpoint was adverse outcome defined as the composite of myocardial infarction, stroke, new-onset arrhythmia or death. We compared lowest Hgb and possible confounders between patients with and without adverse outcomes. Classification and regression tree (CART) analysis was performed to identify the threshold for Hgb where adverse outcomes were more prevalent. Multivariate analysis was performed. Results: We evaluated 935 patients. Mean age was 80±10 years; admission Hgb was 12.5±1.7 g/dL. Diabetes was present in 20%, and 20% had coronary artery disease. Adverse outcomes were noted in 57 patients (6.1%). CART identified ≤7.1 g/dL as the Hgb threshold where adverse outcomes were more prevalent (15% vs. 4.1%, p<0.001). Additionally, a greater number of adverse outcomes were noted in the subgroup of patients having both a hemoglobin ≤7.1 g/dL and advanced age (age >79 years (22%)). After controlling for age, American Society of Anesthesiologist Physical Status Classification (ASA), antiplatelet medication, admission Hgb, time to operation and blood transfusions, lowest Hgb ≤7.1 g/dL remained a risk factor for adverse outcomes. Conclusions: In geriatric patients with isolated hip fractures, Hgb ≤7.1 g/dL is associated with a significantly higher rate of adverse outcomes. This risk was most pronounced in patients older than 79 years; particular care should be taken in this demographic. Level of evidence/study type: Level III/prognostic and epidemiological.

Reversal of pre-injury factor-Xa inhibitors with prothrombin complex concentrates in patients following traumatic brain injury.

INTRODUCTION: There is substantial debate on the best method to reverse factor Xa-inhibitors in patients following traumatic brain injury (TBI). Prothrombin complex concentrates (PCC) have been used for this indication but their role has been questioned. This study reported failure rates with PCC in patients following TBI and as a secondary objective, compared 4-factor (4 F-PCC) and activated PCC (APCC). MATERIAL AND METHODS: Consecutive patients with TBI on factor Xa-inhibitors admitted to one of two trauma centers were retrospectively identified. Patients with penetrating TBI, delays in PCC administration (>6 h), receipt of tranexamic acid, factor VIIa or no follow up CT-scan were excluded. The primary outcome was treatment failure defined as hematoma expansion > 20% from baseline for SDH, EDH or IPH, a new hematoma not present on the initial CT scan or any expansion of a SAH or IVH. Hematoma expansion was further categorized as symptomatic or asymptomatic, designated by a change in the motor GCS score, neurologic exam or change ≥ 3 in NIH Stroke Scale. Multi-variate analysis was performed. RESULTS: There were 43 patients with a mean age of 77 ± 13 years with primarily mild TBI (95%) after a ground level fall (79%). The mean dose was 41 ± 12 units/kg. Sixty percent received 4 F-PCC and 40% APCC. The incidence of treatment failure was 28% (12/43). Of the 12 patients with hematoma expansion, only 3 were symptomatic (9.3%). Hematoma expansion with 4 F-PCC and APCC were similar (27% vs. 29%,p = .859). Only sex was associated with hematoma expansion on multivariate analysis [OR (95% CI) = 6.7 (1.1 - 40.9)]. CONCLUSION: PCC was an effective option for factor Xa inhibitor reversal following TBI. The relationship between radiographic expansion and clinical expansion was poor.

The safety of continuous fascia iliaca block in patients with hip fracture taking pre-injury anticoagulant and/or antiplatelet medications.

BACKGROUND: Fascia iliaca compartment block (FICB) is an effective method to treat pain in adult trauma patients with hip fracture. Of importance is the high prevalence of preinjury anticoagulants and antiplatelet medications in this population. To date, we have not identified any literature that has specifically evaluated the safety of FICB with continuous catheter infusion in patients on antiplatelet and/or anticoagulant therapy. The purpose of this study is to quantify the complication rate associated with FICB in patients who are actively taking prescribed anticoagulant and/or antiplatelet medications prior to injury and identify factors that may predispose patients to an adverse event. METHODS: This retrospective study included consecutive adult trauma patients (age ≥18) with hip fracture who underwent placement of FICB within 24 h of admission and had been taking anticoagulant and/or antiplatelet medications pre-injury. Patients were excluded if their catheter was placed more than 24 h post-hospital admission. Patients were evaluated for demographics, injury severity, laboratory values, medication history, receipt of coagulation-related reversal medications, and complications related to FICB placement. Complications included bleeding at the insertion site requiring catheter removal and 30-day catheter site infection. The incidence of complications was reported and risk factors for complications were identified using univariate and multivariate statistics. RESULTS: There were 124 patients included. The mean age was 81 ± 10 years, and the most common mechanism was ground level fall (94%). Most patients were taking single antiplatelet therapy (65%), followed by anticoagulant alone (21%), combined antiplatelet and anticoagulant therapy (7.3%) and dual antiplatelet therapy (7.3%). The most common antiplatelet was aspirin (88%) and the most common anticoagulant was warfarin (60%). Of the patients taking warfarin, the average INR on admission was 2.3 ± 0.8. Only 1 bleeding complication (0.8%) was noted in a patient prescribed clopidogrel pre-injury which occurred 5 days post-catheter placement. This same patient was noted to have superficial surgical site bleeding most likely secondary to the use of enoxaparin for post-operative deep venous thrombosis prophylaxis. There were 4 orthopedic superficial surgical site infections (3.2%), all remote from the catheter site. The pre-injury medication prescribed in these patients was aspirin 81 mg, aspirin 325 mg, rivaroxaban and dabigatran, respectively. No factors were associated with a complication thus multivariate analysis was not performed. CONCLUSION: The incidence of complications associated with fascia iliaca compartment block (FICB) in adult trauma patients prescribed pre-injury anticoagulants or antiplatelet medications is low. In this retrospective review, we did not identify any complications that were directly associated with the FICB procedure. Fascia iliaca block with continuous infusion catheter placement can be safely performed on patients who are on therapeutic anticoagulant and/or antiplatelet agents.

Utilization of Geriatric Consultation and Team-Based Care.

Geriatric surgical patients experience higher mortality and morbidity rates than their younger counterparts. Three models of geriatric surgical care are described, with a focus on people, plans, and evaluation. These models include geriatric consultation services, geriatric wards, and geriatric multidisciplinary teams. The optimal care plan should be definitive, aggressive, sustainable, safe, and effective, with consideration for patient treatment preferences and wishes.

Stress Ulcer Prophylaxis in Neurocritical Care.

Stress ulcer prophylaxis (SUP) with acid-suppressive drug therapy is widely utilized in critically ill patients following neurologic injury for the prevention of clinically important stress-related gastrointestinal bleeding (CIB). Data supporting SUP, however, largely originates from studies conducted during an era where practices were vastly different than what is considered routine by today's standard. This is particularly true in neurocritical care patients. In fact, the routine provision of SUP has been challenged due to an increasing prevalence of adverse drug events with acid-suppressive therapy and the perception that CIB rates are sparse. This narrative review will discuss current controversies with SUP as they apply to neurocritical care patients. Specifically, the pathophysiology, prevalence, and risk factors for CIB along with the comparative efficacy, safety, and cost-effectiveness of acid-suppressive therapy will be described.

Identifying augmented renal clearance in trauma patients: Validation of the Augmented Renal Clearance in Trauma Intensive Care scoring system.

BACKGROUND: Augmented renal clearance (ARC) is common in trauma patients and associated with subtherapeutic antimicrobial concentrations. This study reported the incidence of ARC, identified ARC risk factors, and described a model to predict ARC (i.e., ARCTIC) that is specific to trauma patients. METHODS: Consecutive trauma patients who were admitted to the intensive care unit between March 2015 and January 2016 and had a measured creatinine clearance (CrCl) were considered for inclusion. Patients were excluded if their serum creatinine (SCr) was greater than 1.3 mg/dL. ARC was defined as a measured CrCl of 130 mL/min or greater. Demographic and trauma-specific variables were then compared, and multivariate analysis was performed. Using these results, a weighted scoring system was constructed and evaluated using receiver operating characteristic curve analysis. ARCTIC score cutoffs were chosen based on sensitivity, specificity, positive predictive value, and negative predictive value. The derived scoring system was then compared to a previously published scoring system for accuracy. RESULTS: There were 133 patients with a mean age of 48 ± 19 years and SCr of 0.8 ± 0.2 mg/dL. The mean measured CrCl was 168 ± 65 mL/min, and the incidence of ARC was 67%. Multivariate analysis revealed the following risk factors for ARC (age, <56: odds ratios [OR], 58.3; 95% confidence interval [CI], 5.2-658.9; age, 56 to 75: OR, 13.5; 95% CI, 1.2-151.7), SCr less than 0.7 mg/dL (OR, 12.5; 95% CI, 3-52.6), and male sex (OR, 6.9; 95% CI, 1.9-24.9). Using these results, the ARCTIC scoring system was: 4 points if younger than 56 years, 3 points if aged 56 years to 75 years, 3 points if SCr less than 0.7 mg/dL, and 2 points if male sex. Receiver operating characteristic curve analysis revealed an area (95% CI) of 0.813 (0.735-0.892) (p < 0.001). An ARCTIC score of 6 or higher had a sensitivity, specificity, positive predictive value, and negative predictive value of 0.843, 0.682, 0.843, and 0.682, respectively. CONCLUSION: The incidence of ARC in trauma patients is high. The ARCTIC score represents a practical, pragmatic system that can be easily applied at the bedside. An ARCTIC score of 6 or higher represents an appropriate cutoff to screen for ARC where antimicrobial adjustments should be considered. LEVEL OF EVIDENCE: Prognostic/epidemiologic study, level III.

The importance of empiric antibiotic dosing in critically ill trauma patients: Are we under-dosing based on augmented renal clearance and inaccurate renal clearance estimates?

BACKGROUND: An accurate assessment of creatinine clearance (CrCl) is essential when dosing medications in critically ill trauma patients. Trauma patients are known to experience augmented renal clearance (i.e., CrCl ≥130 mL/min), and the use of CrCl estimations may be inaccurate leading to under-/over-dosing of medications. As such, our Level I trauma center began using measured CrCl from timed urine collections to better assess CrCl. This study sought to determine the prevalence of augmented renal clearance and the accuracy of calculated CrCl in critically ill trauma patients. METHODS: This observational study evaluated consecutive ICU trauma patients with a timed 12-hour urine collection for CrCl. Data abstracted were patient demographics, trauma-related factors, and CrCl. Augmented renal clearance was defined as measured CrCl ≥130 mL/min. Bias and accuracy were determined by comparing measured and estimated CrCl using the Cockcroft-Gault and other formulas. Bias was defined as measured minus calculated CrCl, and accuracy was calculated CrCl that was within 30% of measured. RESULTS: There were 65 patients with a mean age of 48 years, serum creatinine (SCr) of 0.8 ± 0.3 mg/dL, and injury severity score of 22 ± 14. The incidence of augmented renal clearance was 69% and was more common when age was <67 years and SCr <0.8 mg/dL. Calculated CrCl was significantly lower than measured (131 ± 45 mL/min vs. 169 ± 70 mL/min, p < 0.001) and only moderately correlated (r = 0.610, p < 0.001). Bias was 38 ± 56 mL/min, which was independent of age quartile (p = 0.731). Calculated CrCl was inaccurate in 33% of patients and trauma-related factors were not predictive. CONCLUSION: The prevalence of augmented renal clearance in critically ill trauma patients is high. Formulas used to estimate CrCl in this population are inaccurate and could lead to under-dosing of medications. Measured CrCl should be used in this setting to identify augmented renal clearance and allow for more accurate estimates of renal function. LEVEL OF EVIDENCE: Prognostic/epidemiologic study, level III.

Geriatric trauma G-60 falls with hip fractures: A pilot study of acute pain management using femoral nerve fascia iliac blocks.

BACKGROUND: Hip fractures due to falls cause significant morbidity and mortality among geriatric patients. A significant unmet need is an optimal pain management strategy. Consequently, patients are treated with standard analgesic care (SAC) regimens, which deliver high narcotic doses. However, narcotics are associated with delirium as well as gastrointestinal and respiratory failure risks. The purpose of this pilot study was to determine the safety and effectiveness of ultrasound-guided continuous compartmental fascia iliaca block (CFIB) in patients 60 years or older with hip fractures in comparison with SAC alone. METHODS: We performed a retrospective study of 108 patients 60 years or older, with acute pain secondary to hip fracture (2012-2013). Patient variables were age, sex, comorbidities, and Injury Severity Score (ISS). Primary outcome was pain scores; secondary outcomes included hospital length of stay, discharge disposition, morbidity, and mortality. Statistical analysis was performed using (IBM SPSS version 22). For group comparison (SAC vs. SAC + CFIB) median test, repeated-measures analysis and Student's t test of transformed pain scores were used. RESULTS: Sixty-four patients received SAC only, and 44 patients received SAC + CFIB. Each CFIB placement was successful on first attempt without complications. Median time from emergency department arrival to block placement was 12.5 hours (interquartile range, 4-22 hours). Patients who received SAC + CFIB had significantly lower pain score ratings than patients treated with SAC alone. There were no differences in inpatient morbidity and mortality rates. Patients treated with SAC + CFIB were discharged home more often (p < 0.05). CONCLUSION: Ultrasound-guided CFIB is safe, practical, and readily integrated into the G-60 service for improved pain management of hip fractures. We are now conducting a prospective randomized control trial to confirm our observations. LEVEL OF EVIDENCE: Therapeutic study, level IV.

Trauma-associated pneumonia: time to redefine ventilator-associated pneumonia in trauma patients.

BACKGROUND: The high prevalence of ventilator-associated pneumonia (VAP) in trauma patients has been reported in the literature, but the reasons for this observation remain unclear. We hypothesize that trauma factors play critical roles in VAP etiology. METHODS: In this retrospective study, 1,044 ventilated trauma patients were identified from December 2010 to December 2013. Patient-level trauma factors were used to predict pneumonia as study endpoint. RESULTS: Ninety-five of the 1,044 ventilated trauma patients developed pneumonia. Rib fractures, pulmonary contusion, and failed prehospital intubation were significant predictors of pneumonia in a multivariate model. CONCLUSIONS: It is time to redefine VAP in trauma patients based on the effect of rib fractures, pulmonary contusions, and failed prehospital intubations. The Centers for Disease Control and Prevention definition of VAP needs to be modified to reflect the effect of trauma factors in the etiology of trauma-associated pneumonia.

Evaluation of ultrasound for identification of abdominal wall myofascial components by novice learners.

BACKGROUND: Minimally invasive components separation (MICS) is believed to decrease wound complications by reducing local tissue damage and eliminating the interruption of blood supply to the overlying skin and soft tissue. One drawback to the MICS technique is the difficulty with identifying the correct location for entry into the anterior abdominal wall. We believe that ultrasound can be used to visually assist identification of the correct surgical entry site (the avascular space between the external and internal abdominal oblique muscles, lateral to the linea semilunaris). PURPOSE: The purpose of this study was to assess if novices can readily learn an ultrasound technique for identifying abdominal wall myofascial components via a video education tool. METHODS: This research was an institutional review board-approved, prospective, observational study. Ten surgical residents were asked to watch a 1-min training video containing basic instructions on ultrasound technique for identifying the myofascial anatomy of the anterior abdominal wall. After watching the educational video, the subjects were asked to identify the linea semilunaris first by external anatomy, then by ultrasound. A grader, blinded to the identification of the subject, recorded if the subject correctly identified the location of the linea semilunaris by each method (external anatomy only versus ultrasound guided). RESULTS: Ten subjects were evaluated. Nine of ten (90 %) subjects correctly identified the linea semilunaris with ultrasound. Only three of ten (30 %) subjects correctly identified the linea semilunaris by physical exam. CONCLUSIONS: Ultrasound technology can aid in identification of the abdominal wall musculofascial units in MICS and be easily taught via short video instruction to novices with excellent results. Further studies will be necessary to prove that ultrasound use can decrease complications associated with entry into the appropriate avascular space between the external and internal abdominal oblique muscles, lateral to the linea semilunaris.

The identification of thyroid dysfunction in surgical sepsis.

BACKGROUND: Studies have documented a correlation between hypothyroxinemia and mortality in critically ill patients; however, there are limited data in sepsis. The objective of this study was to assess baseline thyroid function studies and their association with mortality in surgical sepsis. We hypothesized that the relatively decreased levels of free thyroxine (T4), decreased levels of triiodothyronine (T3), and increased thyrotropin-stimulating hormone levels would be associated with mortality. METHODS: This was a retrospective review of prospectively collected data in a surgical intensive care unit. Data evaluated included patient demographics, baseline thyroid function studies, and mortality. Patients were categorized as having sepsis, severe sepsis, or septic shock. A value of p < 0.05 was considered significant. RESULTS: Within 24 months, 231 septic patients were accrued. The mean age was 59 ± 3 years, and 43% were male. Thirty-nine patients were diagnosed as having sepsis, 131 as having severe sepsis, and 61 as having septic shock. There were no statistically significant differences between the T3, free T4, or thyrotropin-stimulating hormone levels at baseline and the different categorizations of sepsis.T4 levels were increased in all patients but to a significantly lesser extent in those who died. Similarly, T3 levels were significantly decreased in patients who died. CONCLUSION: In surgical sepsis, decreased T3 levels at baseline are associated with mortality. These data do not support the administration of levothyroxine (T4) because it is already elevated and would preferentially be converted to reverse T3 (inactive) in critical illness; however, replacement with liothyronine (T3) might be rational. LEVEL OF EVIDENCE: Epidemiologic study, level III.

Robotic telepresence: a helpful adjunct that is viewed favorably by critically ill surgical patients.

BACKGROUND: The purpose of this study was to assess how surgical intensive care unit (SICU) patients and their families would perceive robotic telepresence. We hypothesized that they would view such technology positively. METHODS: This research was an Institutional Review Board-approved prospective observational study. Our robotic telepresence program augmented the SICU multidisciplinary team rounding process. We anonymously surveyed patients and their families on their perceptions. Those who interacted at least once with the robot served as our participant base. RESULTS: Twenty-four patients and 26 family members completed the survey. Ninety-two percent of respondents were comfortable with the robot, and 84% believed communication was "easy." Ninety percent did not perceive the robot as "annoying" and 92% did not believe that "the doctor cared less about them" because of the robot. Ninety-two percent of respondents supported the continued use of the robot. CONCLUSIONS: Robotic telepresence was viewed positively by patients and their families in the SICU. Furthermore, they believed the robot was beneficial to their care and indicated their support for its continued use.

The epidemiology of sepsis in general surgery patients.

BACKGROUND: Sepsis is increasing in hospitalized patients. Our purpose is to describe its current epidemiology in a general surgery (GS) intensive care unit (ICU) where patients are routinely screened and aggressively treated for sepsis by an established protocol. METHODS: Our prospective, Institutional Review Board-approved sepsis research database was queried for demographics, biomarkers reflecting organ dysfunction, and mortality. Patients were grouped as sepsis, severe sepsis, or septic shock using refined consensus criteria. Data are compared by analysis of variance, Student's t test, and χ test (p<0.05 significant). RESULTS: During 24 months ending September 2009, 231 patients (aged 59 years ± 3 years; 43% men) were treated for sepsis. The abdomen was the source of infection in 69% of patients. Several baseline biomarkers of organ dysfunction (BOD) correlated with sepsis severity including lactate, creatinine, international normalized ratio, platelet count, and d-dimer. Direct correlation with mortality was noted with particular baseline BODs including beta natriuretic peptide, international normalized ratio, platelet count, aspartate transaminase, alanine aminotransferase, and total bilirubin. Most patients present with severe sepsis (56%) or septic shock (26%) each with increasing multiple BODs. Septic shock has prohibitive mortality rate (36%), and those who survive septic shock have prolonged ICU stays. CONCLUSION: In general surgery ICU patients, sepsis is predominantly caused by intra-abdominal infection. Multiple BODs are present in severe sepsis and septic shock but are notably advanced in septic shock. Despite aggressive sepsis screening and treatment, septic shock remains a morbid condition.

Computer protocol facilitates evidence-based care of sepsis in the surgical intensive care unit.

BACKGROUND: Care of sepsis has been the focus of intense research and guideline development for more than two decades. With ongoing success of computer protocol (CP) technology and with publication of Surviving Sepsis Campaign (SSC) guidelines, we undertook protocol development for management of sepsis of surgical intensive care unit patients in mid-2006. METHODS: A sepsis protocol was developed and implemented in The Methodist Hospital (TMH) (Houston, TX) surgical intensive care unit (27 beds) together with a sepsis research database. We compare paper-protocol (PP) (2008) and CP (2009) performance and results of the SSC guideline performance improvement initiative (2005-2008). TMH surgical intensive care unit sepsis protocol was developed to implement best evidence and to standardize decision making among surgical intensivists, nurse practitioners, and resident physicians. RESULTS: The 2008 and 2009 sepsis protocol cohorts had very similar number of patients, age, % male gender, Acute Physiology and Chronic Health Evaluation scoring system II, and Sequential Organ Failure Assessment scores. The 2008 PP patients had greater baseline lactate concentration consistent with greater mortality rate. Antibiotic agents were administered to 2009 CP cohort patients sooner than 2008 PP cohort patients. Both cohorts received similar volume of intravenous fluid boluses. Comparing 6-hour resuscitation bundle compliance, the 2009 CP cohort was substantially greater than SSC eighth quarter and 2008 PP cohorts (79% vs. 31% vs. 29%), and mortality rate was much less when using the CP (14% vs. 31% vs. 24%). CONCLUSIONS: Our comprehensive sepsis protocol has enabled rapid and consistent implementation of evidence-based care, and, implemented as a bedside CP, contributed to decreased mortality rate for management of surgical sepsis.

Identification of cardiac dysfunction in sepsis with B-type natriuretic peptide.

BACKGROUND: B-type natriuretic peptide (BNP) is secreted in response to myocardial stretch and has been used clinically to assess volume overload and predict death in congestive heart failure. More recently, BNP elevation has been demonstrated with septic shock and is predictive of death. How BNP levels relate to cardiac function in sepsis remains to be established. STUDY DESIGN: Retrospective review of prospectively gathered sepsis database from a surgical ICU in a tertiary academic hospital. Initial BNP levels, patient demographics, baseline central venous pressure levels, and in-hospital mortality were obtained. Transthoracic echocardiography was performed during initial resuscitation per protocol. RESULTS: During 24 months ending in September 2009, two hundred and thirty-one patients (59 ± 3 years of age, 43% male) were treated for sepsis. Baseline BNP increased with initial sepsis severity (ie, sepsis vs severe sepsis vs septic shock, by ANOVA; p < 0.05) and was higher in those who died vs those who lived (by Fisher's exact test; p < 0.05). Of these patients, 153 (66%) had early echocardiography. Low ejection fraction (<50%) was associated with higher BNP (by Fisher's exact test; p < 0.05) and patients with low ejection fraction had a higher mortality (39% vs 20%; odds ratio = 3.03). We found no correlation between baseline central venous pressure (12.7 ± 6.10 mmHg) and BNP (526.5 ± 82.10 pg/mL) (by Spearman's ρ, R(s) = .001) for the entire sepsis population. CONCLUSIONS: In surgical sepsis patients, BNP increases with sepsis severity and is associated with early systolic dysfunction, which in turn is associated with death. Monitoring BNP in early sepsis to identify occult systolic dysfunction might prompt earlier use of inotropic agents.

Performance of a computerized protocol for trauma shock resuscitation.

BACKGROUND: A computerized protocol was developed and used to standardize bedside clinician decision making for resuscitation of shock due to severe trauma during the first day in the intensive care unit (ICU) at a metropolitan Level I trauma center. We report overall performance of a computerized protocol for resuscitation of shock due to severe trauma, incorporating two options for resuscitation monitoring and intervention intensity, according to: (1) duration of use and (2) acceptance of computerized protocol-generated instructions. METHODS: A computerized protocol operated by clinicians, using a personal computer (PC) at the bedside, was used to guide clinical decision making for resuscitation of patients meeting specific injury and shock criteria. The protocol generated instructions that could be accepted or declined. Clinician acceptance of the protocol instructions was stored by the PC software in a database for each patient. A rule-based, data-driven protocol was developed using literature evidence, expert opinion, and ongoing protocol performance analysis. Logic-flow diagrams were used to facilitate communication among multidisciplinary protocol development team members. The protocol was computerized using standard programming methods and implemented using cart-mounted PCs with a touch screen and keyboard interfaces. Protocol progression began with patient demographic data and criteria entry, confirmation of hemodynamic monitor instrumentation, request for specific hemodynamic performance data, and instructions for specific interventions (or no intervention). Use and performance of the computerized protocol was recorded in a protocol execution database. The protocol was continuously maintained with new literature evidence and database performance analysis findings. Initially implemented in 2000, the computerized protocol was refined in 2004 with two options for resuscitation intensity: pulmonary artery catheter- and central venous pressure-directed resuscitation. RESULTS: Over 2 years ending at August 2006, a total of 193 trauma patients (mean Injury Severity Score was 27, survival rate 89%) were resuscitated using the computerized protocol. Protocol duration was 4400 hours or 22.7 +/- 0.4 hours per patient. The computerized protocol generated 3724 instructions (19 +/- 1 per patient) that required a bedside clinician response. In all, 94% of these instructions were accepted by the bedside clinician users. CONCLUSIONS: A computerized protocol to guide decision making for trauma shock resuscitation in a Level 1 trauma center surgical ICU was developed and used as standard of care. During 2 years ending at August 2006, 94% of computer-generated instructions for specific interventions or measurements of hemodynamic performance were accepted by bedside clinicians, indicating appropriate, useful design and reliance on the computerized protocol system.

A multidisciplinary protocol improves electrolyte replacement and its effectiveness.

BACKGROUND: We implemented a multidisciplinary electrolyte replacement protocol in a tertiary referral center surgical intensive care unit. The purpose of this study was to evaluate its efficacy. METHODS: This was a retrospective study. The electrolyte replacement protocol was designed for the replacement of potassium, magnesium, and phosphorous and was nurse driven. Data evaluated included patient demographics and details specific to electrolyte replacement. Univariate analyses were performed by using the Student t test and the Fisher exact test. A P value of <.05 was considered significant. RESULTS: After implementation of the protocol, overall electrolyte replacement improved from 70% to 79% (P = .03), and its overall effectiveness increased from 50% to 65% (P = .01). Individual electrolyte replacement, effectiveness, and dosing varied. CONCLUSIONS: The implementation of a multidisciplinary electrolyte replacement protocol in a tertiary referral center surgical intensive care unit significantly improved both overall electrolyte replacement and its effectiveness.

Central venous pressure versus pulmonary artery catheter-directed shock resuscitation.

Previously, we developed a protocol for shock resuscitation of severe trauma patients to reverse shock and regain hemodynamic stability during the first 24 intensive care unit (ICU) hours. Key hemodynamic measurements of cardiac output and preload were obtained using a pulmonary artery catheter (PAC). As an alternative, we developed a protocol that used central venous pressure (CVP) to guide decision making for interventions to regain hemodynamic stability [mean arterial pressure (MAP) >or= 65 mmHg and heart rate (HR) or= 6 mEq/L or systolic blood pressure < 90 mmHg, 3) transfusion of >or= 1 unit packed red blood cells (PRBC), or >or= age 65 years with two of three criteria. Patients with brain injury were excluded. Data were recorded prospectively. In 24 months ending July 31, 2006, of 193 patients, 114 (59%) were assigned CVP- directed resuscitation, and 79 (41%) were assigned PAC-directed resuscitation. A subgroup of 11 (10%) initially assigned CVP was reassigned PAC-directed resuscitation (7 +/- 2 h after start) due to hemodynamic instability. Crystalloid fluid and PRBC resuscitation volumes for PAC (8 +/- 1 L lactated Ringer's [LR], 5 +/- 0.4 units PRBC) were > CVP (5 +/- 0.4 L LR, 3 +/- 0.3 units PRBC) and similar to CVP - PAC protocol subgroup patients (9 +/- 2 L LR, 5 +/- 1 units PRBC). Intensive care unit (ICU) stay and survival rate for PAC (18 +/- 2 days, 75%) were similar to CVP - PAC (17 +/- 4 days, 73%) and worse than CVP protocol subgroup patients (9 +/- 1 days, 98%). Traumatic shock resuscitation is feasible using CVP as a primary hemodynamic monitor as part of a protocol that includes explicit definition of hemodynamic instability and where PAC monitoring is readily available. Computerized decision support provides a technique to implement complex protocol care processes and analyze patient response.

Validation of a screening tool for the early identification of sepsis.

BACKGROUND: Sepsis is the leading cause of mortality in noncoronary intensive care units. Recent evidence based guidelines outline strategies for the management of sepsis and studies have shown that early implementation of these guidelines improves survival. We developed an extensive logic-based sepsis management protocol; however, we found that early recognition of sepsis was a major obstacle to protocol implementation. To improve this, we developed a three-step sepsis screening tool with escalating levels of decision making. We hypothesized that aggressive screening for sepsis would improve early recognition of sepsis and decrease sepsis-related mortality by insuring early appropriate interventions. METHODS: Patients admitted to the surgical intensive care unit were screened twice daily by our nursing staff. The initial screen assesses the systemic inflammatory response syndrome parameters (heart rate, temperature, white blood cell count, and respiratory rate) and assigns a numeric score (0-4) for each. Patients with a score of > or = 4 screened positive proceed to the second step of the tool in which a midlevel provider attempts to identify the source of infection. If the patients screens positive for both systemic inflammatory response syndrome and an infection, the intensivist was notified to determine whether to implement our sepsis protocol. RESULTS: Over 5 months, 4,991 screens were completed on 920 patients. The prevalence of sepsis was 12.2%. The screening tool yielded a sensitivity of 96.5%, specificity of 96.7%, a positive predictive value of 80.2%, and a negative predictive value of 99.5%. In addition, sepsis-related mortality decreased from 35.1% to 23.3%. CONCLUSIONS: The three step sepsis screening tool is a valid tool for the early identification of sepsis. Implementation of this tool and our logic-based sepsis protocol has decreased sepsis-related mortality in our SICU by one third.

An overview of FDA regulatory requirements for new medical devices.

BACKGROUND: US national healthcare expenditure reached over 2 trillion dollars in 2007. medical device expenditure has remained nearly a constant 6% of the total healthcare expenditure. medical technology may be one of the driving factors increasing healthcare costs. the number of medical device (which includes diagnostic tests) and laboratory equipment manufacturers, and investment in research for medical devices continue to rise. medical device manufacturers can receive a higher than average return on investment if they successfully navigate the food and drug administration (FDA) approval process. OBJECTIVE: this paper focuses on the series of steps a manufacturer can pursue to facilitate the introduction of a new device to the us market. METHOD: a review of the FDA regulations and current literature was conducted. RESULTS/CONCLUSION: exemption from a full review by the FDA owing to substantial equivalence is one of the pathways a manufacturer can pursue for quicker and easier approval of the new device. three classes of devices are reviewed, as are some of the key regulations governing them. the regulations for advertising and promotion are still unclear because of the gray area that exists between the federal trade commission and the FDA. this paper concludes by summarizing the advertising and promotion regulations set forth by the FDA during the post-approval phase.