Mark E. Nunnally

Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012.

Objective:To provide an update to the “Surviving Sepsis Campaign Guidelines for Management of Severe Sepsis and Septic Shock,” last published in 2008. Design:A consensus committee of 68 international experts representing 30 international organizations was convened. Nominal groups were assembled at key international meetings (for those committee members attending the conference). A formal conflict of interest policy was developed at the onset of the process and enforced throughout. The entire guidelines process was conducted independent of any industry funding. A stand-alone meeting was held for all subgroup heads, co- and vice-chairs, and selected individuals. Teleconferences and electronic-based discussion among subgroups and among the entire committee served as an integral part of the development. Methods:The authors were advised to follow the principles of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to guide assessment of quality of evidence from high (A) to very low (D) and to determine the strength of recommendations as strong (1) or weak (2). The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized. Some recommendations were ungraded (UG). Recommendations were classified into three groups: 1) those directly targeting severe sepsis; 2) those targeting general care of the critically ill patient and considered high priority in severe sepsis; and 3) pediatric considerations. Results:Key recommendations and suggestions, listed by category, include: early quantitative resuscitation of the septic patient during the first 6 hrs after recognition (1C); blood cultures before antibiotic therapy (1C); imaging studies performed promptly to confirm a potential source of infection (UG); administration of broad-spectrum antimicrobials therapy within 1 hr of recognition of septic shock (1B) and severe sepsis without septic shock (1C) as the goal of therapy; reassessment of antimicrobial therapy daily for de-escalation, when appropriate (1B); infection source control with attention to the balance of risks and benefits of the chosen method within 12 hrs of diagnosis (1C); initial fluid resuscitation with crystalloid (1B) and consideration of the addition of albumin in patients who continue to require substantial amounts of crystalloid to maintain adequate mean arterial pressure (2C) and the avoidance of hetastarch formulations (1C); initial fluid challenge in patients with sepsis-induced tissue hypoperfusion and suspicion of hypovolemia to achieve a minimum of 30 mL/kg of crystalloids (more rapid administration and greater amounts of fluid may be needed in some patients) (1C); fluid challenge technique continued as long as hemodynamic improvement, as based on either dynamic or static variables (UG); norepinephrine as the first-choice vasopressor to maintain mean arterial pressure ≥ 65 mm Hg (1B); epinephrine when an additional agent is needed to maintain adequate blood pressure (2B); vasopressin (0.03 U/min) can be added to norepinephrine to either raise mean arterial pressure to target or to decrease norepinephrine dose but should not be used as the initial vasopressor (UG); dopamine is not recommended except in highly selected circumstances (2C); dobutamine infusion administered or added to vasopressor in the presence of a) myocardial dysfunction as suggested by elevated cardiac filling pressures and low cardiac output, or b) ongoing signs of hypoperfusion despite achieving adequate intravascular volume and adequate mean arterial pressure (1C); avoiding use of intravenous hydrocortisone in adult septic shock patients if adequate fluid resuscitation and vasopressor therapy are able to restore hemodynamic stability (2C); hemoglobin target of 7–9 g/dL in the absence of tissue hypoperfusion, ischemic coronary artery disease, or acute hemorrhage (1B); low tidal volume (1A) and limitation of inspiratory plateau pressure (1B) for acute respiratory distress syndrome (ARDS); application of at least a minimal amount of positive end-expiratory pressure (PEEP) in ARDS (1B); higher rather than lower level of PEEP for patients with sepsis-induced moderate or severe ARDS (2C); recruitment maneuvers in sepsis patients with severe refractory hypoxemia due to ARDS (2C); prone positioning in sepsis-induced ARDS patients with a PaO2/FIO2 ratio of ⩽ 100 mm Hg in facilities that have experience with such practices (2C); head-of-bed elevation in mechanically ventilated patients unless contraindicated (1B); a conservative fluid strategy for patients with established ARDS who do not have evidence of tissue hypoperfusion (1C); protocols for weaning and sedation (1A); minimizing use of either intermittent bolus sedation or continuous infusion sedation targeting specific titration endpoints (1B); avoidance of neuromuscular blockers if possible in the septic patient without ARDS (1C); a short course of neuromuscular blocker (no longer than 48 hrs) for patients with early ARDS and a Pao2/Fio2 < 150 mm Hg (2C); a protocolized approach to blood glucose management commencing insulin dosing when two consecutive blood glucose levels are > 180 mg/dL, targeting an upper blood glucose ⩽ 180 mg/dL (1A); equivalency of continuous veno-venous hemofiltration or intermittent hemodialysis (2B); prophylaxis for deep vein thrombosis (1B); use of stress ulcer prophylaxis to prevent upper gastrointestinal bleeding in patients with bleeding risk factors (1B); oral or enteral (if necessary) feedings, as tolerated, rather than either complete fasting or provision of only intravenous glucose within the first 48 hrs after a diagnosis of severe sepsis/septic shock (2C); and addressing goals of care, including treatment plans and end-of-life planning (as appropriate) (1B), as early as feasible, but within 72 hrs of intensive care unit admission (2C). Recommendations specific to pediatric severe sepsis include: therapy with face mask oxygen, high flow nasal cannula oxygen, or nasopharyngeal continuous PEEP in the presence of respiratory distress and hypoxemia (2C), use of physical examination therapeutic endpoints such as capillary refill (2C); for septic shock associated with hypovolemia, the use of crystalloids or albumin to deliver a bolus of 20 mL/kg of crystalloids (or albumin equivalent) over 5 to 10 mins (2C); more common use of inotropes and vasodilators for low cardiac output septic shock associated with elevated systemic vascular resistance (2C); and use of hydrocortisone only in children with suspected or proven “absolute”‘ adrenal insufficiency (2C). Conclusions:Strong agreement existed among a large cohort of international experts regarding many level 1 recommendations for the best care of patients with severe sepsis. Although a significant number of aspects of care have relatively weak support, evidence-based recommendations regarding the acute management of sepsis and septic shock are the foundation of improved outcomes for this important group of critically ill patients.

Targeted temperature management in critical care: A report and recommendations from five professional societies*

Objective:Representatives of five international critical care societies convened topic specialists and a nonexpert jury to review, assess, and report on studies of targeted temperature management and to provide clinical recommendations. Data Sources:Questions were allocated to experts who reviewed their areas, made formal presentations, and responded to questions. Jurors also performed independent searches. Sources used for consensus derived exclusively from peer-reviewed reports of human and animal studies. Study Selection:Question-specific studies were selected from literature searches; jurors independently determined the relevance of each study included in the synthesis. Conclusions and Recommendations:1) The jury opines that the term “targeted temperature management” replace “therapeutic hypothermia.” 2) The jury opines that descriptors (e.g., “mild”) be replaced with explicit targeted temperature management profiles. 3) The jury opines that each report of a targeted temperature management trial enumerate the physiologic effects anticipated by the investigators and actually observed and/or measured in subjects in each arm of the trial as a strategy for increasing knowledge of the dose/duration/response characteristics of temperature management. This enumeration should be kept separate from the body of the report, be organized by body systems, and be made without assertions about the impact of any specific effect on the clinical outcome. 4) The jury STRONGLY RECOMMENDS targeted temperature management to a target of 32°C–34°C as the preferred treatment (vs. unstructured temperature management) of out-of-hospital adult cardiac arrest victims with a first registered electrocardiography rhythm of ventricular fibrillation or pulseless ventricular tachycardia and still unconscious after restoration of spontaneous circulation (strong recommendation, moderate quality of evidence). 5) The jury WEAKLY RECOMMENDS the use of targeted temperature management to 33°C–35.5°C (vs. less structured management) in the treatment of term newborns who sustained asphyxia and exhibit acidosis and/or encephalopathy (weak recommendation, moderate quality of evidence).

Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU.

Objective: To provide clinicians with evidence-based strategies to optimize the support of the family of critically ill patients in the ICU. Methods: We used the Council of Medical Specialty Societies principles for the development of clinical guidelines as the framework for guideline development. We assembled an international multidisciplinary team of 29 members with expertise in guideline development, evidence analysis, and family-centered care to revise the 2007 Clinical Practice Guidelines for support of the family in the patient-centered ICU. We conducted a scoping review of qualitative research that explored family-centered care in the ICU. Thematic analyses were conducted to support Population, Intervention, Comparison, Outcome question development. Patients and families validated the importance of interventions and outcomes. We then conducted a systematic review using the Grading of Recommendations, Assessment, Development and Evaluations methodology to make recommendations for practice. Recommendations were subjected to electronic voting with pre-established voting thresholds. No industry funding was associated with the guideline development. Results: The scoping review yielded 683 qualitative studies; 228 were used for thematic analysis and Population, Intervention, Comparison, Outcome question development. The systematic review search yielded 4,158 reports after deduplication and 76 additional studies were added from alerts and hand searches; 238 studies met inclusion criteria. We made 23 recommendations from moderate, low, and very low level of evidence on the topics of: communication with family members, family presence, family support, consultations and ICU team members, and operational and environmental issues. We provide recommendations for future research and work-tools to support translation of the recommendations into practice. Conclusions: These guidelines identify the evidence base for best practices for family-centered care in the ICU. All recommendations were weak, highlighting the relative nascency of this field of research and the importance of future research to identify the most effective interventions to improve this important aspect of ICU care.

ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research.

Objectives:To update the Society of Critical Care Medicine’s guidelines for ICU admission, discharge, and triage, providing a framework for clinical practice, the development of institutional policies, and further research. Design:An appointed Task Force followed a standard, systematic, and evidence-based approach in reviewing the literature to develop these guidelines. Measurements and Main Results:The assessment of the evidence and recommendations was based on the principles of the Grading of Recommendations Assessment, Development and Evaluation system. The general subject was addressed in sections: admission criteria and benefits of different levels of care, triage, discharge timing and strategies, use of outreach programs to supplement ICU care, quality assurance/improvement and metrics, nonbeneficial treatment in the ICU, and rationing considerations. The literature searches yielded 2,404 articles published from January 1998 to October 2013 for review. Following the appraisal of the literature, discussion, and consensus, recommendations were written. Conclusion:Although these are administrative guidelines, the subjects addressed encompass complex ethical and medico-legal aspects of patient care that affect daily clinical practice. A limited amount of high-quality evidence made it difficult to answer all the questions asked related to ICU admission, discharge, and triage. Despite these limitations, the members of the Task Force believe that these recommendations provide a comprehensive framework to guide practitioners in making informed decisions during the admission, discharge, and triage process as well as in resolving issues of nonbeneficial treatment and rationing. We need to further develop preventive strategies to reduce the burden of critical illness, educate our noncritical care colleagues about these interventions, and improve our outreach, developing early identification and intervention systems.

The incidence and risk factors for perioperative cardiac arrest observed in the national anesthesia clinical outcomes registry.

BACKGROUND:Cardiac arrest is a rare but important event in the operating room and postanesthesia care unit, when surgical patients are most intensively monitored. Several recent publications have reported the rate of cardiac arrest in surgical patients during the subsequent hospital stay but have not uniquely identified the immediate perioperative period. We hypothesized that cardiac arrest during this time (intraprocedure and postanesthesia care) would occur at a lower frequency than that described for inpatient hospital care in the available literature. METHODS:We extracted data from all cardiac arrests and immediate perioperative deaths reported to the National Anesthesia Clinical Outcomes Registry for the period from 2010 to 2013 and analyzed for anesthesia-related risk factors. We compared these data to published rates of in-hospital cardiac arrest after surgery. RESULTS:Overall, the risk of cardiac arrest was 5.6 per 10,000 cases, which is less than in previous reports of in-hospital arrests in surgical patients overall, with an associated mortality from the arrest of 58.4%. The rate of cardiac arrest increased with age and ASA physical status. The rate of cardiac arrest was significantly higher for males, as was the mortality. CONCLUSIONS:The National Anesthesia Clinical Outcomes Registry is an emerging resource for examination of perioperative and anesthesia-related outcomes. Cardiac arrest is less frequent in the periprocedural setting than later in the hospital course, with most arrests predictably occurring in patients with ASA physical status III–V. The finding of increased risk of mortality in male patients cannot be readily explained and should prompt future research attention.

Regularly irregular: how groups reconcile cross-cutting agendas and demand in healthcare

The flow of technical work in acute healthcare varies unpredictably, in patterns that occur regularly enough that they can be managed. Acute care organizations develop ways to hedge resources so that they are available if they are needed. This pragmatic approach to the distribution of work among and across groups shows how rules can be used to manage a response to irregular demands for care. However, no rule set can be complete enough to cover this setting’s variety of care demands. Expertise is also needed to tie together the loose ends of conflicts that remain where rules no longer suffice. Many informal solutions to systemic problems go unnoticed unless they are the subjects of study. Naturalistic decision making (NDM) methods such as observational study, interviews, and process tracing reveal the activities of workers in their natural settings. Results of findings from such explorations of technical work can improve understanding of large scale work processes and, ultimately, patient safety. We have explored how practitioners cope with the demands that the system presents to them. While not all succeed, successful initiatives workers have developed demonstrate how their solutions create resilience at large scale.

Time to Get Off this Pig's Back? The Human Factors Aspects of the Mismatch Between Device and Real-world Knowledge in the Health Care Environment

Objectives: Automated piggybacks are purported to make drug administration safer and more reliable. We evaluated the human factors of piggyback infusion, investigated the practice in our institution, and analyzed incidents from an anonymous database to better characterize the practice and substantiate these assertions. Methods: To find examples of problems with piggyback, or secondary infusions, we searched the Food and Drug Administrations on-line incident database for incidents involving piggybacks. As part of a task analysis, 19 senior nurses each programmed 2 of 4 different pumps for a simulated piggyback infusion. To characterize infusion practice, we evaluated data logs from 55 infusion devices used in our institution. Results: Incidents from the database provided strong evidence that potential problems existed with piggyback infusions. Nurse behaviors suggested mismatches between the task, user, and devices that can lead to adverse events. Log files showed piggybacks were a common practice, and that available safeguards were not used. Conclusions: Our multiple data sources suggest automated piggyback infusion practice is neither simple nor safe. Incident report analysis suggests these findings contribute to adverse events. Further study is needed to understand and improve the safety of this practice.

Between choice and chance: the role of human factors in acute care equipment decisions.

Objectives: We report on a human factors evaluation project at a major urban teaching hospital that was intended to use human factors methods to assist the selection of a new infusion device among 4 commercially available models. Methods: The project provided an expert evaluation of the pumps, collected data on programming each pump by a sample of practitioners, tabulated recent adverse event reports in the US Food and Drug Administration Manufacturer and User Device Experience database, and observed actual use in intensive care and hematology/oncology units. Results: Programming by clinicians showed no correlation between clinical experience and ability to program any of the pumps under consideration. Field observations reflected diverse use patterns across services that required ease of use pumps did not offer. Upon review of a final candidate pump, purchasing preferences superceded clinical considerations. Conclusions: Equipment and systems that are intended for use by clinicians must necessarily reflect an understanding of actual clinical practice to be well suited for use at the sharp (operator) end. However, purchase decisions for medical equipment including infusion devices are typically made by hospital staff members who are experienced in administrative and clinical matters but have no expertise in the evaluation of complex equipment. This project demonstrates how collaboration by human factors and clinical professionals can inform equipment decisions and assist clinician performance to improve patient safety. It also reveals how technical decisions that directly influence anesthesia staff performance and patient safety are subject to organizational factors such as social and political pressure.

Taking the Septic Patient to the Operating Room

The acutely septic patient is a multifaceted challenge for the anesthetist. Unlike most elective surgery patients, acutely septic patients have severe systemic disease before the physiologic insults of anesthesia and surgery. The decision to operate is usually informed by the urgent or emergent need to correct a severe surgical problem and weighed against the higher risks of morbidity and mortality from the procedure itself. The care of the septic patient in the intensive care unit can help guide operating room management. However, the acuity and time course of intraoperative events, including hemorrhage and drug-induced shock states, compel the anesthetist to respond aggressively with therapies that may or may not be strongly substantiated with long-term data in the intensive care unit setting. The anesthesiologist must place considerations concerning short-term survival from the acute insult of surgery ahead of longer-term considerations.

A Smartphone-based Decision Support Tool Improves Test Performance Concerning Application of the Guidelines for Managing Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy.

Background:The American Society of Regional Anesthesia and Pain Medicine (ASRA) consensus statement on regional anesthesia in the patient receiving antithrombotic or thrombolytic therapy is the standard for evaluation and management of these patients. The authors hypothesized that an electronic decision support tool (eDST) would improve test performance compared with native physician behavior concerning the application of this guideline. Methods:Anesthesiology trainees and faculty at 8 institutions participated in a prospective, randomized trial in which they completed a 20-question test involving clinical scenarios related to the ASRA guidelines. The eDST group completed the test using an iOS app programmed to contain decision logic and content of the ASRA guidelines. The control group completed the test by using any resource in addition to the app. A generalized linear mixed-effects model was used to examine the effect of the intervention. Results:After obtaining institutional review board’s approval and informed consent, 259 participants were enrolled and randomized (eDST = 122; control = 137). The mean score was 92.4 ± 6.6% in the eDST group and 68.0 ± 15.8% in the control group (P < 0.001). eDST use increased the odds of selecting correct answers (7.8; 95% CI, 5.7 to 10.7). Most control group participants (63%) used some cognitive aid during the test, and they scored higher than those who tested from memory alone (76 ± 15% vs. 57 ± 18%, P < 0.001). There was no difference in time to completion of the test (P = 0.15) and no effect of training level (P = 0.56). Conclusions:eDST use improved application of the ASRA guidelines compared with the native clinician behavior in a testing environment.