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SERIES “ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION TESTING” 

Edited by V. Brusasco, R. Crapo and G. Viegi 

Number 2 in this Series

 [1]: #F13

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Standardisation of spirometry

Background Traditional approaches to mechanical ventilation use tidal volumes of 10 to 15 ml per kilogram of body weight and may cause stretch-induced lung injury in patients with acute lung injury and the acute respiratory distress syndrome. We therefore conducted a trial to determine whether ventilation with lower tidal volumes would improve the clinical outcomes in these patients. Methods Patients with acute lung injury and the acute respiratory distress syndrome were enrolled in a multicenter, randomized trial. The trial compared traditional ventilation treatment, which involved an initial tidal volume of 12 ml per kilogram of predicted body weight and an airway pressure measured after a 0.5-second pause at the end of inspiration (plateau pressure) of 50 cm of water or less, with ventilation with a lower tidal volume, which involved an initial tidal volume of 6 ml per kilogram of predicted body weight and a plateau pressure of 30 cm of water or less. The primary outcomes were death before a patient was discharged home and was breathing without assistance and the number of days without ventilator use from day 1 to day 28. Results The trial was stopped after the enrollment of 861 patients because mortality was lower in the group treated with lower tidal volumes than in the group treated with traditional tidal volumes (31.0 percent vs. 39.8 percent, P=0.007), and the number of days without ventilator use during the first 28 days after randomization was greater in this group (mean [+/-SD], 12+/-11 vs. 10+/-11; P=0.007). The mean tidal volumes on days 1 to 3 were 6.2+/-0.8 and 11.8+/-0.8 ml per kilogram of predicted body weight (P Conclusions In patients with acute lung injury and the acute respiratory distress syndrome, mechanical ventilation with a lower tidal volume than is traditionally used results in decreased mortality and increases the number of days without ventilator use.

Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome.

According to W. Edwards Deming, American companies require nothing less than a transformation of management style and of governmental relations with industry. In Out of the Crisis, originally published in 1982, Deming offers a theory of management based on his famous 14 Points for Management. Management's failure to plan for the future, he claims, brings about loss of market, which brings about loss of jobs. Management must be judged not only by the quarterly dividend, but by innovative plans to stay in business, protect investment, ensure future dividends, and provide more jobs through improved product and service. In simple, direct language, he explains the principles of management transformation and how to apply them.

Out of the Crisis

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 ke

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

The acute respiratory distress syndrome (ARDS) was defined in 1994 by the American-European Consensus Conference (AECC); since then, issues regarding the reliability and validity of this definition have emerged. Using a consensus process, a panel of experts convened in 2011 (an initiative of the European Society of Intensive Care Medicine endorsed by the American Thoracic Society and the Society of Critical Care Medicine) developed the Berlin Definition, focusing on feasibility, reliability, validity, and objective evaluation of its performance. A draft definition proposed 3 mutually exclusive categories of ARDS based on degree of hypoxemia: mild (200 mm Hg < PaO2/FIO2 ≤ 300 mm Hg), moderate (100 mm Hg < PaO2/FIO2 ≤ 200 mm Hg), and severe (PaO2/FIO2 ≤ 100 mm Hg) and 4 ancillary variables for severe ARDS: radiographic severity, respiratory system compliance (≤40 mL/cm H2O), positive end-expiratory pressure (≥10 cm H2O), and corrected expired volume per minute (≥10 L/min). The draft Berlin Definition was empirically evaluated using patient-level meta-analysis of 4188 patients with ARDS from 4 multicenter clinical data sets and 269 patients with ARDS from 3 single-center data sets containing physiologic information. The 4 ancillary variables did not contribute to the predictive validity of severe ARDS for mortality and were removed from the definition. Using the Berlin Definition, stages of mild, moderate, and severe ARDS were associated with increased mortality (27%; 95% CI, 24%-30%; 32%; 95% CI, 29%-34%; and 45%; 95% CI, 42%-48%, respectively; P < .001) and increased median duration of mechanical ventilation in survivors (5 days; interquartile [IQR], 2-11; 7 days; IQR, 4-14; and 9 days; IQR, 5-17, respectively; P < .001). Compared with the AECC definition, the final Berlin Definition had better predictive validity for mortality, with an area under the receiver operating curve of 0.577 (95% CI, 0.561-0.593) vs 0.536 (95% CI, 0.520-0.553; P < .001). This updated and revised Berlin Definition for ARDS addresses a number of the limitations of the AECC definition. The approach of combining consensus discussions with empirical evaluation may serve as a model to create more accurate, evidence-based, critical illness syndrome definitions and to better inform clinical care, research, and health services planning.

Acute respiratory distress syndrome: the Berlin Definition.

We retrospectively compared two computerized IV insulin-treatment protocols, eProtocol-insulin and Glucosafe, insilico using ICU data. We used clinical data from eProtocol-insulin supported cohorts to simulate patient models in Glucosafe. The amounts of insulin recommended by these protocols were compared and evaluated at different blood glucose ranges. Results indicated that Glucosafe consistently provided better dosing suggestions for managing insulin in ICU patients. Introduction Intravenous (IV) insulin-treatment protocols to manage blood glucose in critically ill patients in the ICU vary widely. They have different heuristics or use modeling techniques that are not based on reproducible methods. These protocols will generate different dosing recommendations which may lead to different patient outcomes. An efficient method for comparing different protocols, before using them in clinical trials, would be valuable. Methods We selected two computerized IV insulin-treatment protocols for comparison; eProtocol-insulin 1 and Glucosafe 2 . eProtocol-insulin is an heuristic rule-based protocol used for managing ICU patient blood glucose at Intermountain Healthcare. Internally, eProtocol-insulin assumes a linear rate of change in glucose in response to changes in IV insulin. Glucosafe is a more complex, physiologic model-based, decision support system for blood glucose control. It calculates insulin sensitivity based on blood glucose measurements, amount of insulin given and various nutritional inputs. The model also considers insulin saturation effects and glucose absorption rate when recommending insulin doses. We evaluated these two protocols retrospectively using clinical data from 408 patients managed with eProtocolinsulin. We collected patient demographic data including gender, age, weight and height. We extracted 20,362 instances of ICU patient blood glucose values, IV insulin doses and recommended by eProtocol-Insulin. Other clinical data used by Glucosafe included medications, types of diabetes and types of nutrition received by patients. We then compared the amount of insulin recommended by eProtocol-insulin and Glucosafe within different blood glucose ranges; low (below 80 mg/dL), target (80-110 mg/dL), and high (above 110 mg/dL). Results & Discussion At the low blood glucose range, a lower insulin dose is preferred to prevent hypoglycemia. At the high blood glucose range, a higher insulin dose is preferred (to lower blood glucose to the normoglycemic range faster). In the low range, 61.8% of Glucosafe’s recommendations were lower than eProtocol-insulin. In the target range, 62.6% of Glucosafe’s recommendations were lower than eProtocol-insulin. In the high range, 66.0% of Glucosafe recommendations were higher than eProtocol-insulin. Paired Wilcoxon rank sum tests showed that insulin doses compared within the different blood glucose ranges were different and statistically significant (p < 0.01). Glucosafe produced more favorable recommendations, overall. Conclusion We expect that our proposed analytical framework will allow credible in-silico comparisons of different protocols.

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Evaluation and comparison of two computerized IV insulin-treatment protocols using patient data from the ICU

Animal experiments, clinical experiments, clinical care: important cross-talk.

PCIRV--a mode of ventilation associated with problems

A step forward--but the path is still unclear.

Critical Care Medicine www.ccmjournal.org 1783 (e.g., lactate, cultures, antibiotics, fluid challenge) in both public and private hospitals. Machado et al (1) found that public hospitals in Brazil had poor compliance with minimal improvement during their observation period, whereas private hospitals had greater improvements in both compliance and in in-hospital mortality. Although this observational study does not allow for causal inferences, the assessment of compliance with the protocol in conjunction with mortality in two populations makes a compelling argument for the importance of context within which clinical care is delivered. In the private institutions, the intervention resulted in a large increase in compliance and large reduction in mortality. In the public institution, the intervention slightly increased compliance, and there was no reduction in mortality. These findings support the large observational studies that demonstrated that mortality decreases with increased compliance with the sepsis bundle elements (2, 3). This relationship is not unique to sepsis; the mortality of patients is decreased as more evidence-based care is applied (4). Perhaps the greatest improvements in healthcare over the coming decade will not be the discovery of new treatments, but rather the successful implementation of interventions we related to transport to the CT scanner are not reported, although the authors did not identify major transport events. It should be mentioned that this center is well-experienced with both intra and inter-hospital transport of ECMO patients. In summary, the current report should compel us to examine what protocols this center and others with other low rates of ICH and good neurologic outcome use to establish “best practice.” Extrapolating single-center outcomes to the field at large will likely require standardization and collaboration. With the rapidly increasing use of ECMO, establishing “best practices” is needed now more than ever. The days of “my way or the highway” need to change to “what way is the best way” to benefit patient care.

Alan H. Morris

Papers

Evaluation and comparison of two computerized IV insulin-treatment protocols using patient data from the ICU

Animal experiments, clinical experiments, clinical care: important cross-talk.

PCIRV--a mode of ventilation associated with problems

A step forward--but the path is still unclear.

The Importance of Clinical Context on Assessing Outcomes in Sepsis.