A Comparison of Different Intensive Care Unit Definitions Derived from the German Administrative Data Set: A Methodological, Real-World Data Analysis from 86 Helios Hospitals.

Background: The intensive care unit (ICU) is a scarce resource in all health care systems, necessitating a well-defined utilization. Therefore, benchmarks are essential; and yet, they are limited due to heterogenous definitions of what an ICU is. This study analyzed the case distribution, patient characteristics, and hospital course and outcomes of 6,204,093 patients in the German Helios Hospital Group according to 10 derived ICU definitions. We aimed to set a baseline for the development of a nationwide, uniform ICU definition. Methods: We analyzed ten different ICU definitions: seven derived from the German administrative data set of claims data according to the German Hospital Remuneration Act, three definitions were taken from the Helios Hospital Group's own bed classification. For each ICU definition, the size of the respective ICU population was analyzed. Due to similar patient characteristics for all ten definitions, we selected three indicator definitions to additionally test statistically against IQM. Results: We analyzed a total of 5,980,702 completed hospital cases, out of which 913,402 referred to an ICU criterion (14.7% of all cases). A key finding is the significant variability in ICU population size, depending on definitions. The most restrictive definition of only mechanical ventilation (DOV definition) resulted in 111,966 (1.9%) cases; mechanical ventilation plus typical intensive care procedure codes (IQM definition) resulted in 210,147 (3.5%) cases; defining each single bed individually as ICU or IMC (ICUá´§IMC definition) resulted in 411,681 (6.9%) cases; and defining any coded length of stay at ICU (LOSi definition) resulted in 721,293 (12.1%) cases. Further testing results for indicator definitions are reported. Conclusions: The size of the population, utilization rates, outcomes, and capacity assumptions clearly depend on the definition of ICU. Therefore, the underlying ICU definition should be stated when making any comparisons. From previous studies, we anticipated that 25-30% of all ICU patients should be mechanically ventilated, and therefore, we conclude that the ICUá´§IMC definition is the most plausible approximation. We suggest a mandatory application of a clearly defined ICU term for all hospitals nationwide for improved benchmarking and data analysis.

Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia: a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study).

PURPOSE: The CIGMA study investigated a novel human polyclonal antibody preparation (trimodulin) containing ~ 23% immunoglobulin (Ig) M, ~ 21% IgA, and ~ 56% IgG as add-on therapy for patients with severe community-acquired pneumonia (sCAP). METHODS: In this double-blind, phase II study (NCT01420744), 160 patients with sCAP requiring invasive mechanical ventilation were randomized (1:1) to trimodulin (42 mg IgM/kg/day) or placebo for five consecutive days. Primary endpoint was ventilator-free days (VFDs). Secondary endpoints included 28-day all-cause and pneumonia-related mortality. Safety and tolerability were monitored. Exploratory post hoc analyses were performed in subsets stratified by baseline C-reactive protein (CRP; ≥ 70 mg/L) and/or IgM (≤ 0.8 g/L). RESULTS: Overall, there was no statistically significant difference in VFDs between trimodulin (mean 11.0, median 11 [n = 81]) and placebo (mean 9.6; median 8 [n = 79]; p = 0.173). Twenty-eight-day all-cause mortality was 22.2% vs. 27.8%, respectively (p = 0.465). Time to discharge from intensive care unit and mean duration of hospitalization were comparable between groups. Adverse-event incidences were comparable. Post hoc subset analyses, which included the majority of patients (58-78%), showed significant reductions in all-cause mortality (trimodulin vs. placebo) in patients with high CRP, low IgM, and high CRP/low IgM at baseline. CONCLUSIONS: No significant differences were found in VFDs and mortality between trimodulin and placebo groups. Post hoc analyses supported improved outcome regarding mortality with trimodulin in subsets of patients with elevated CRP, reduced IgM, or both. These findings warrant further investigation. TRIAL REGISTRATION: NCT01420744.

The effect of a novel extracorporeal cytokine hemoadsorption device on IL-6 elimination in septic patients: A randomized controlled trial.

OBJECTIVE: We report on the effect of hemoadsorption therapy to reduce cytokines in septic patients with respiratory failure. METHODS: This was a randomized, controlled, open-label, multicenter trial. Mechanically ventilated patients with severe sepsis or septic shock and acute lung injury or acute respiratory distress syndrome were eligible for study inclusion. Patients were randomly assigned to either therapy with CytoSorb hemoperfusion for 6 hours per day for up to 7 consecutive days (treatment), or no hemoperfusion (control). Primary outcome was change in normalized IL-6-serum concentrations during study day 1 and 7. RESULTS: 97 of the 100 randomized patients were analyzed. We were not able to detect differences in systemic plasma IL-6 levels between the two groups (n = 75; p = 0.15). Significant IL-6 elimination, averaging between 5 and 18% per blood pass throughout the entire treatment period was recorded. In the unadjusted analysis, 60-day-mortality was significantly higher in the treatment group (44.7%) compared to the control group (26.0%; p = 0.039). The proportion of patients receiving renal replacement therapy at the time of enrollment was higher in the treatment group (31.9%) when compared to the control group (16.3%). After adjustment for patient morbidity and baseline imbalances, no association of hemoperfusion with mortality was found (p = 0.19). CONCLUSIONS: In this patient population with predominantly septic shock and multiple organ failure, hemoadsorption removed IL-6 but this did not lead to lower plasma IL-6-levels. We did not detect statistically significant differences in the secondary outcomes multiple organ dysfunction score, ventilation time and time course of oxygenation.

Routine follow-up cranial computed tomography for deeply sedated, intubated, and ventilated multiple trauma patients with suspected severe head injury.

BACKGROUND: Missed or delayed detection of progressive neuronal damage after traumatic brain injury (TBI) may have negative impact on the outcome. We investigated whether routine follow-up CT is beneficial in sedated and mechanically ventilated trauma patients. METHODS: The study design is a retrospective chart review. A routine follow-up cCT was performed 6 hours after the admission scan. We defined 2 groups of patients, group I: patients with equal or recurrent pathologies and group II: patients with new findings or progression of known pathologies. RESULTS: A progression of intracranial injury was found in 63 patients (42%) and 18 patients (12%) had new findings in cCT 2 (group II). In group II a change in therapy was found in 44 out of 81 patients (54%). 55 patients with progression or new findings on the second cCT had no clinical signs of neurological deterioration. Of those 24 patients (44%) had therapeutic consequences due to the results of the follow-up cCT. CONCLUSION: We found new diagnosis or progression of intracranial pathology in 54% of the patients. In 54% of patients with new findings and progression of pathology, therapy was changed due to the results of follow-up cCT. In trauma patients who are sedated and ventilated for different reasons a routine follow-up CT is beneficial.

Lower tidal volume strategy (≈3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study.

BACKGROUND: Acute respiratory distress syndrome is characterized by damage to the lung caused by various insults, including ventilation itself, and tidal hyperinflation can lead to ventilator induced lung injury (VILI). We investigated the effects of a low tidal volume (V(T)) strategy (V(T) ≈ 3 ml/kg/predicted body weight [PBW]) using pumpless extracorporeal lung assist in established ARDS. METHODS: Seventy-nine patients were enrolled after a 'stabilization period' (24 h with optimized therapy and high PEEP). They were randomly assigned to receive a low V(T) ventilation (≈3 ml/kg) combined with extracorporeal CO2 elimination, or to a ARDSNet strategy (≈6 ml/kg) without the extracorporeal device. The primary outcome was the 28-days and 60-days ventilator-free days (VFD). Secondary outcome parameters were respiratory mechanics, gas exchange, analgesic/sedation use, complications and hospital mortality. RESULTS: Ventilation with very low V(T)'s was easy to implement with extracorporeal CO2-removal. VFD's within 60 days were not different between the study group (33.2 ± 20) and the control group (29.2 ± 21, p = 0.469), but in more hypoxemic patients (PaO2/FIO2 ≤150) a post hoc analysis demonstrated significant improved VFD-60 in study patients (40.9 ± 12.8) compared to control (28.2 ± 16.4, p = 0.033). The mortality rate was low (16.5%) and did not differ between groups. CONCLUSIONS: The use of very low V(T) combined with extracorporeal CO2 removal has the potential to further reduce VILI compared with a 'normal' lung protective management. Whether this strategy will improve survival in ARDS patients remains to be determined (Clinical trials NCT 00538928).

[If mechanical ventilation comes to its limits: extracorporeal lung assist]. / Lungenersatzverfahren - Wenn Beatmung alleine nicht mehr reicht: Extrakorporale Lungenassistenzverfahren.

Extracorporeal lung assist can be performed pumpless by using the arterio-venous driving pressure or pumpdriven in a veno-venous mode. Oxygenation is maintained via the native lungs and depends mainly on mean airway pressure during mechanical ventilation.Extracorporeal lung assist can be part of a multimodal treatment concept in patients with acute lung injury. It aims at a further reduction of the applied tidal volume and peak pressures in order to reduce the intensity of the pulmonary and systemic inflammatory response which is the main factor for the development of multi-organ failure in this group of patients. Eventually patients with acute exacerbation of a chronic pulmonary disease might also benefit from extracorporeal ventilation.

[If the extracorporeal lung assist comes to its limit: use and management of extracorporeal membrane oxygenation in severe acute respiratory distress syndrome]. / Lungenersatzverfahren - Einsatz und Management extrakorporaler Lungenersatzverfahren.

In patients with the most severe forms of acute respiratory distress syndrome (ARDS) refractory to conventional mechanical ventilation and adjunctive or rescue therapies like kinetic therapy, inhaled vasodilators or extracorporeal CO2-elimination (extracorporeal lung assist), the use of the extracorporeal membrane oxygenation (ECMO) can secure gas exchange. Due to technical improvements and miniaturization, the new ECMO system is safer and simpler. Nowadays the ECMO-systems are heparin-coated, so that there is no need of therapeutic systemic anticoagulation, and thus bleeding complications are less frequent. Recent data suggests, that outcome of patients with severe ARDS treated with ECMO may improve. This review describes the function and the management of ECMO-therapy in ARDS-patients.

[The DGAI training module 2 in anaesthetic focussed sonography: vascular sonography]. / DGAI-zertifizierte Seminarreihe Anästhesie Fokussierte Sonografie - Modul 2: Gefäßsonografie.

Modul 2 will provide the theory and practical training of the sonographically guided puncture of central and peripheral veins and arteries. In doing so patients of all age groups are taken into consideration. Combined with the content of the other modules this series of workshops, which was initiated by our society, might be a first step in defining a new core competency of our specialty. The confident use of ultrasound in vascular puncture sharpens our dedicated professional competence and will contribute to continuously improve the quality and safety of anaesthesiologic patient care.

Delayed systemic air embolism in a child with severe blunt chest trauma treated with high-frequency oscillatory ventilation.

PURPOSE: Trauma is the leading cause of death in children over one year of age. Even with optimal field care, blunt chest trauma with hemoptysis is a potentially fatal injury due to exsanguination or arterial air embolism. Most often, cardiovascular collapse that is unresponsive to therapy develops shortly after endotracheal intubation and initiation of positive pressure ventilation. We present a case of arterial air embolism after blunt chest trauma that manifested atypically late, i.e., one hour after initiation of positive pressure ventilation. CLINICAL FEATURES: A 13-yr-old Caucasian boy was admitted to the emergency room after he had been run over by a car. While lung protective ventilation, including high frequency oscillatory ventilation, was performed, an alveolar to pulmonary venous fistula developed. Although the complication was diagnosed quickly, involvement of the cerebral and coronary arteries resulted in irreversible cerebral damage and fatal hemodynamic collapse. Necropsy confirmed severe damage of the right pulmonary lower lobe with involvement of the pulmonary vessels. CONCLUSION: Patients with blunt chest trauma and hemoptysis present a diagnostic dilemma with limited therapeutic options.

Pulmonary effects of positive end-expiratory pressure and fluid therapy in experimental lung injury.

The separate effects of positive end-expiratory pressure (PEEP) and intravascular volume administration on the histopathologic lung injury were not investigated in experimental lung injury previously. The authors hypothesized that high PEEP and a restrictive volume therapy would yield the best oxygenation and the least degree of lung injury. Pigs (52.8 ± 3.4 kg) underwent saline lavage-induced lung injury. The animals were ventilated either with low PEEP (mean PEEP 9 to 12 cm H2O) and liberal volume therapy using hydroxyethyl starch (LowP/Vol+) or high PEEP (mean PEEP 21 cm H2O) combined with recruitment maneuvers and liberal (HighP/Vol+) or restrictive volume therapy (HighP/Vol-). After 6.5 hours, lung injury was determined by using a histopathologic score evaluating overdistension, edema, exsudation, and inflammation. When volume therapy was liberal, high PEEP (HighP/Vol+) improved the Pao2/Fio2 index (416 ± 80 mm Hg) compared to low PEEP (LowP/Vol+, 189 ± 55 mm Hg; P < .05) but there was no difference in the median (interquartile range) lung injury score: 1.6 (1.2-1.9) and 1.9 (1.4-2.0). High PEEP with restrictive volume therapy (HighP/Vol-) did not further improve oxygenation (400 ± 55 mm Hg) but ameliorated the degree of lung injury: 0.9 (0.8-1.4) (P < .05). In lavage-induced lung injury, high PEEP improved oxygenation, but restrictive volume administration markedly reduced the lung injury score, mainly by reduced edema.

High-frequency oscillation combined with arteriovenous extracorporeal lung assist reduces lung injury.

In order to optimize the lung-protective potential of high-frequency oscillatory ventilation (HFOV), it is currently recommended to maximize oscillatory frequencies. However, very high frequencies may lead to insufficient CO(2) elimination with severe respiratory acidosis. Arteriovenous extracorporeal lung assist (av-ECLA) allows near total CO(2) removal, thereby allowing for maximization of the lung-protective potential of HFOV. The aim of this study was to determine the impact of HFOV and av-ECLA on lung inflammation and function compared to conventional lung-protective ventilation. In a porcine surfactant depletion model of lung injury, the authors randomly assigned 16 female pigs to conventional lung-protective ventilation and HFOV/ECLA. Both strategies were combined with an "open-lung" approach. Gas exchange and hemodynamic parameters were measured at intervals during the 24-hour study period. Postmortem, lung tissue was analyzed to determine histological damage and lung inflammation. The authors found that the combination of HFOV and av-ECLA (1) allows significant reductions in mean and peak airway pressures; and (2) reduces histological signs of lung inflammation in the basal regions of the lung. HFOV/av-ECLA reduces histological signs of lung inflammation compared to conventional lung-protective ventilation strategies. Thus, combination of HFOV and av-ECLA might be a further lung-protective tool if conventional ventilation strategies are failing.

Combining "open-lung" ventilation and arteriovenous extracorporeal lung assist: influence of different tidal volumes on gas exchange in experimental lung failure.

BACKGROUND: Although low-tidal ventilation may reduce mortality in acute respiratory distress syndrome (ARDS), it can also result in severe respiratory acidosis and lung derecruitment. This study tested the hypothesis that combining "open-lung" ventilation and arteriovenous extracorporeal lung assist (av-ECLA) allows for maximal tidal volume (VT) reduction without the development of decompensated respiratory acidosis and impairment of oxygenation. MATERIAL/METHODS: After induction of ARDS in eight female pigs (56.1+/-3.2 kg), lung recruitment was performed and positive end-expiratory pressure was set 3 cmH2O above the lower inflection point of the pressure-volume curve. All animals were ventilated in the pressure-controlled ventilation mode (PCV) with VTs ranging from 0-8 ml/kg. At each VT, gas exchange and hemodynamic measurements were obtained with the av-ECLA circuit clamped and declamped. With each declamping, the gas flow through the membrane lung was set to 10 l of oxygen/min. The respiratory rate was adjusted to maintain normocapnia, but limited to 40/min. RESULTS: After lung recruitment, oxygenation remained significantly improved although VTs were minimized to 0 ml/kg (p<0.05). PaO2 was significantly improved during PCV and av-ECLA compared with PCV alone at VTs <4 ml/kg (p<0.05). With VT <6 ml/kg, severe acidosis could only be avoided if PCV was combined with av-ECLA. CONCLUSIONS: Due to sufficient CO2 elimination during av-ECLA, the VTs could be reduced to 0-2 ml/kg without the risk of decompensated respiratory acidosis. It was also shown that the "open-lung" strategy chosen was associated with sustained improvements in oxygenation, even though VTs were minimized.

[Which perioperative tidal volume for patients with healthy lungs undergoing elective surgery? A qualitative systematic review of current evidence]. / Intraoperative Beatmung--Welches Tidalvolumen sollte bei lungengesunden Patienten angewandt werden? Eine qualitativ-systematische Ubersichtsarbeit.

BACKGROUND: Lung-protective ventilation strategies for patients suffering from acute lung injury (ALI/ARDS) are well- accepted measures to improve outcome including mortality. But what tidal volume is the best for the patient with non-injured lungs undergoing elective surgery? METHODS: We searched the literature for studies that analysed perioperative tidal volume in patients not suffering from ALI/ARDS. RESULTS: 10 studies were detected that matched our query. Mostly on patients undergoing major or cardiac surgery. CONCLUSION: Only a few studies exist which examine the effect of protective ventilation settings on healthy lungs of patients not being critical-ill. The reported results are very heterogeneous and do not strongly support a lung- protective ventilation strategy. However, apart from reasoning based on pre-clinical experimental data, there is some clinical evidence, that suggests using lower tidal volumes in patients undergoing major or cardiac surgery, even if the patient does not present with an ALI/ARDS and is not critically ill at the time when the surgical procedure is performed.

[Clinical pathway, quality circle and standard operating procedures as tools for quality management in the trauma suite]. / Schockraummanagement--Prozessqualität durch klinische Behandlungspfade, Qualitätszirkel und Standard Operating Procedures.

In each hospital the trauma resuscitation room in emergency departments is one of the areas with the highest rate of critical incidents. Delayed and insufficient medical interventions have a high impact on negative patient outcomes. Anticipating and dealing with critical situations might reduce preventable errors in the treatment process. This can be achieved by implementing an algorithm-based structured work flow. In this context some elements of quality management are well-established in clinical practice. In the present study we describe the implementation of a clinical pathway and an interdisciplinary quality circle to improve management of the trauma patient.

Acute respiratory distress induced by repeated saline lavage provides stable experimental conditions for 24 hours in pigs.

Surfactant depletion is most often used to study acute respiratory failure in animal models. Because model stability is often criticized, the authors tested the following hypotheses: Repeated pulmonary lavage with normal saline provides stable experimental conditions for 24 hours with a PaO2/FiO2 ratio < 300 mm Hg. Lung injury was induced by bilateral pulmonary lavages in 8 female pigs (51.5 +/- 4.8 kg). The animals were ventilated for 24 hours (PEEP: 5 cm H2O; tidal volume: 6 mL/kg; respiratory rate: 30/min). After 24 hours the animals were euthanized. For histopathology slides from all pulmonary lobes were obtained. Supernatant of the bronchoalveolar fluid collected before induction of acute respiratory distress syndrome (ARDS) and after 24 hours was analyzed. A total of 19 +/- 6 lavages were needed to induce ARDS. PaO2/FiO2 ratio and pulmonary shunt fraction remained significantly deteriorated compared to baseline values after 24 hours (P < .01). Slight to moderate histopathologic changes were detected. Significant increases of tumor necrosis factor (TNF)-alpha, interleukin (IL)-1beta, and IL-6 were observed after 24 hours (P < .01). The presented surfactant depletion-based lung injury model was associated with increased pulmonary inflammation and fulfilled the criteria of acute ling injury (ALI) for 24 hours.

Whole-body multislice computed tomography as the first line diagnostic tool in patients with multiple injuries: the focus on time.

OBJECTIVE: Whole-body multislice helical computed tomography (MSCT) becomes increasingly important as a diagnostic tool in patients with multiple injuries. We describe time requirement of two different diagnostic approaches to multiple injuries one with whole-body-MSCT (MSCT Trauma-Protocol) as the sole radiologic procedure and one with conventional use of radiography, combined with abdominal ultrasound and organ focused CT (Conventional-Trauma-Protocol). METHODS: Observational study with retrospective analysis of time requirements for resuscitation, diagnostic workup and transfer to definitive treatment after changing from conventional to MSCT Trauma-Protocol. Group I: data from trauma patients imaged with whole-body MSCT. Group II: data of trauma patients investigated with conventional trauma protocol before the introduction of MSCT-Trauma-Protocol. RESULTS: The complete diagnostic workup in group I (n = 82) was finished after 23 minutes (17-33 minutes) [median; interquartile range (IQR)] and after 70 minutes (IQR, 56-85) in group II (n = 79). The definitive management plan based on a completed diagnostic workup was devised after 47 minutes (IQR, 37-59) in group I and after 82 minutes (IQR, 66-110) in group II. CONCLUSION: A whole-body MSCT-based diagnostic approach to multiple injuries might shorten the time interval from arrival in the trauma emergency room until obtaining a final diagnosis and management plan in patients with multiple injuries and might, therefore, contribute to improvements in patient care.

Application of standard operating procedures accelerates the process of trauma care in patients with multiple injuries.

OBJECTIVE: Objective of this study is to determine whether the formulation of standard operating procedures (SOPs) and their incorporation in a trauma pathway are associated with an improvement of trauma treatment process. MATERIALS AND METHODS: A retrospective data analysis of traumatized patients treated before the introduction of the SOPs (group I) and after a SOP training period of 6 months (group II) was performed. The time required for resuscitation (period A), diagnostic workup (period B) and total stay in the emergency room (period C) was used as a marker of trauma team performance. Data are described as median and interquartile range. Mortality within the first 24 h and within 30 days was determined. RESULTS: Eighty-two patients in group I and 79 patients in group II were analysed. Period A took 13 (10-17) min in group I and 10 (8-15) min in group II, respectively (P<0.001). Period B was finished after 23 (17-33) min in group I and after 17 (13-21) min in group II (P<0.001). Period C took 47 (37-59) min in group I and 42 (34-53) min in group II, respectively (P<0.05). A difference in mortality was not observed. CONCLUSION: SOP incorporation in a trauma pathway shortens the total stay in the emergency room, resuscitation time and the time to achieve definitive diagnosis in multiple trauma patients. Thus, it can be concluded that organization and timing of trauma treatment steps help in improving the quality of trauma treatment process.

Arteriovenous Extracorporeal Lung Assist Allows For Maximization Of Oscillatory Frequencies: A Large-animal Model Of Respiratory Distress.

BACKGROUND: Although the minimization of the applied tidal volume (VT) during high-frequency oscillatory ventilation (HFOV) reduces the risk of alveolar shear stress, it can also result in insufficient CO2-elimination with severe respiratory acidosis. We hypothesized that in a model of acute respiratory distress (ARDS) the application of high oscillatory frequencies requires the combination of HFOV with arteriovenous extracorporeal lung assist (av-ECLA) in order to maintain or reestablish normocapnia. METHODS: After induction of ARDS in eight female pigs (56.5 ± 4.4 kg), a recruitment manoeuvre was performed and intratracheal mean airway pressure (mPaw) was adjusted 3 cmH2O above the lower inflection point (Plow) of the pressure-volume curve. All animals were ventilated with oscillatory frequencies ranging from 3-15 Hz. The pressure amplitude was fixed at 60 cmH2O. At each frequency gas exchange and hemodynamic measurements were obtained with a clamped and de-clamped av-ECLA. Whenever the av-ECLA was de-clamped, the oxygen sweep gas flow through the membrane lung was adjusted aiming at normocapnia. RESULTS: Lung recruitment and adjustment of the mPaw above Plow resulted in a significant improvement of oxygenation (p < 0.05). Compared to lung injury, oxygenation remained significantly improved with rising frequencies (p < 0.05). Normocapnia during HFOV was only maintained with the addition of av-ECLA during frequencies of 9 Hz and above. CONCLUSION: In this animal model of ARDS, maximization of oscillatory frequencies with subsequent minimization of VT leads to hypercapnia that can only be reversed by adding av-ECLA. When combined with a recruitment strategy, these high frequencies do not impair oxygenation.