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Within the evidence-based medicine paradigm, randomized controlled trials represent the “gold standard” to produce reliable evidence. Indeed, planning and implementing randomized controlled trials in critical care medicine presents limitations because of intrinsic and structural problems. As a consequence, observational studies still occur frequently. In these cases, propensity score (PS) (probability of receiving a treatment conditional on observed covariates) is an increasingly used technique to adjust the results. Few studies addressed the specific issue of a PS correction of repeated-measures designs. Three techniques for correcting the analysis of nonrandomized designs (matching, stratification, regression adjustment) are presented in a tutorial form and applied to a real case study: the comparison between intravenous and enteral sedative therapy in the intensive care unit setting. After showing the results before and after the use of PS, we suggest that such a tool allows to partially overcoming the bias associated with the observational nature of the study. It permits to correct the estimates for any observed covariate, while unobserved confounders cannot be controlled for. Propensity score represents a useful additional tool to estimate the effects of treatments in nonrandomized studies. In the case study, an enteral sedation approach was equally effective to an intravenous regime, allowing for a lower level of sedation and spare of resources.

The aim of this study is to evaluate continuous wrist actigraphy (measurement of limb movements) in intensive care unit patients as a neurologic status monitoring. This is a prospective, observational study on motor activity of adult patients using wrist actigraphs. Nurses recorded the number of sleep and agitation hours as well as assessed pain and anxiety level (verbal numeric rating) and the agitation/sedation level (Richmond Agitation-Sedation Scale). Thirteen mechanically ventilated patients were studied during their whole intensive care unit stay (total, 165 patients/d). The number of surveyed movements was gathered for each hour, obtaining an estimation of patient motor status. This measure was different between days and nights (33.3 [20.3-49.0] vs 8.5 [4.4-13.8]; P < .001), with a correlation with sleeping hours estimated by nurses ( P = .017 during the days [D], P < .001 during the nights [N]), agitation hours ( P = .002 D, P = .017 N), Richmond Agitation-Sedation Scale value ( P < .001 D and N), pain ( P = .012 D), and anxiety ( P < .001 D) verbal numeric rating. No differences were found using epochs of 15 or 120 seconds. Compliance with patients and nurses was acceptable. Patients' limb movements were significantly related to all studied neurologic status indexes. Continuous actigraphy measuring may become important as a clinical tool both to guide utilization of sedative drugs and to enhance early recognition and management of agitation.

Study objectives: Noninvasive ventilation, although effective as treatment for patients with acute cardiogenic pulmonary edema when prolonged for hours, is of limited use in the emergency department (ED). The aim of the study was to determine whether a short attempt at noninvasive pressure support ventilation avoids ICU admittance and to identify lack of response prediction variables. Design: Prospective inception cohort study. Setting: ED of a university hospital. Patients: Fifty-eight consecutive patients with cardiogenic pulmonary edema who had been unresponsive to medical treatment and were admitted between January 1999 and December 2000. Interventions: Pressure support ventilation was instituted through a full-face mask until the resolution of respiratory failure. A 15-min “weaning test” was performed to evaluate clinical stability. Responder patients were transferred to a medical ward. Nonresponding patients were intubated and were admitted to the ICU. Main outcome measures: The included optimal length of intervention, the avoidance of ICU admittance, the incidence of myocardial infarction, and predictive lack of response criteria. Results: Patients completed the trial (mean [± SD] duration, 96 ± 40 min). None of the responders (43 patients; 74%) was subsequently ventilated or was admitted to the ICU. Two new episodes of myocardial infarction were observed. Thirteen of 58 patients died. A mean arterial pressure of < 95 mm Hg (odds ratio [OR], 10.6; 95% confidence interval [CI], 1.8 to 60.8; p < 0.01) and COPD (OR, 9.4; 95% CI, 1.6 to 54.0; p < 0.05) at baseline predicted the lack of response to noninvasive ventilation. Conclusions: A short attempt at noninvasive ventilation is effective in preventing invasive assistance. A 15-min weaning test can identify patients who will not need further invasive ventilatory support. COPD and hypotension at baseline are negative predictive criteria.

The aim of sedation is to provide comfort and minimize anxiety. However, adverse effects are noteworthy, and the optimal end point of sedation in intensive care unit patients is still debated. We analyzed if a level 2 on the Ramsay Scale (ie, awake, cooperative, oriented, tranquil patient) is suitable for an invasive therapeutic approach. Forty-two patients requiring respiratory support and sedation for at least 4 days were enrolled in a prospective interventional cohort study aiming at maintaining patients awake and collaborative. The Ramsay score was recorded 3 times a day. Once a day, the nurse in charge evaluated adequacy of sedation according to the compliance with nursing care and therapeutic maneuvers in the previous 24 hours. Data were collected until patients were ventilated. Overall, 264 of 582 days were classified as conscious. Sedation was adequate in 93.9% of them. In conscious days, a higher Simplified Acute Physiology Score II score and male sex significantly correlated with inadequate sedation. In a population of severe intensive care unit patients, conscious sedation was achieved in almost half of the days spent on ventilation. The positive implications (eg, on length of weaning and cost of sedation) of a conservative sedation strategy may be highly relevant.

Sedation by the enteral route is unusual in intensive medicine. We analysed the feasibility/efficacy of long-term enteral sedation in ventilated critically ill patients. Prospective interventional cohort study. General ICU. Forty-two patients needing ventilation and sedation for at least 4 days. At admission, sedation was induced with propofol or midazolam. Enteral hydroxyzine (+/- enteral lorazepam) was added in all patients within the second day. Intravenous drugs were gradually withdrawn, trying to maintain only enteral sedation after the initial 48 h. Analgesia was provided with continuous IV fentanyl. Sedation level was assessed evaluating, on a daily basis, patients' compliance to the invasive care and comparing observed vs planned Ramsay scores three times a day. Excluding the first 2 days of patient-stabilisation and fast titration of sedation level, 577 days with ventilatory support were analysed. In 460 days (79.7%) total enteral sedation was given. This percentage rose to 94.2% when the requested Ramsay was 2 (347 days). Daily sedation was judged as adequate in 82.8% of days of total enteral sedation. Thirty-one patients had total enteral as the exclusive route of sedation. After 24-48 h, enteral sedation may replace, totally/in part, IV sedation in ventilated patients. Total enteral sedation easily fits the target when a Ramsay score 2 is planned. When a deeper sedation is needed, a mixed regimen is effective and lowers IV drug dosages. No side effects were reported.

Noninvasive ventilation, although effective as treatment for patients with acute cardiogenic pulmonary edema when prolonged for hours, is of limited use in the emergency department (ED). The aim of the study was to determine whether a short attempt at noninvasive pressure support ventilation avoids ICU admittance and to identify lack of response prediction variables. Prospective inception cohort study. ED of a university hospital. Fifty-eight consecutive patients with cardiogenic pulmonary edema who had been unresponsive to medical treatment and were admitted between January 1999 and December 2000. Pressure support ventilation was instituted through a full-face mask until the resolution of respiratory failure. A 15-min “weaning test” was performed to evaluate clinical stability. Responder patients were transferred to a medical ward. Nonresponding patients were intubated and were admitted to the ICU. The included optimal length of intervention, the avoidance of ICU admittance, the incidence of myocardial infarction, and predictive lack of response criteria. Patients completed the trial (mean [± SD] duration, 96 ± 40 min). None of the responders (43 patients; 74%) was subsequently ventilated or was admitted to the ICU. Two new episodes of myocardial infarction were observed. Thirteen of 58 patients died. A mean arterial pressure of < 95 mm Hg (odds ratio [OR], 10.6; 95% confidence interval [CI], 1.8 to 60.8; p < 0.01) and COPD (OR, 9.4; 95% CI, 1.6 to 54.0; p < 0.05) at baseline predicted the lack of response to noninvasive ventilation. A short attempt at noninvasive ventilation is effective in preventing invasive assistance. A 15-min weaning test can identify patients who will not need further invasive ventilatory support. COPD and hypotension at baseline are negative predictive criteria.

PurposeTo propose an algorithm of the major and minor diagnostic criteria for macular myopic choroidal neovascularization (mCNV).MethodsThis single-center, retrospective, cross-sectional study was based in Istituto Auxologico Italiano, Milan, Italy. Two authors evaluated the clinical and imaging parameters of eyes with high myopia (spherical equivalent of -6D or less) and suspected to have naïve, recurrent, or inactive mCNV. Recordings of the eyes that met the inclusion criteria were then independently evaluated by two other senior retinal specialists. Fluorescein angiography (FA), spectral domain optical coherence tomography (SD-OCT), and OCT angiography were used for multimodal imaging.ResultsOne-hundred and twenty-two eyes (n = 107; 39 men, 68 women) were included in the study. The mean patient age was 66 years (range, 22–89 years). There were 83 and 39 eyes in the active mCNV and control groups, respectively.The best diagnostic algorithm had positive- and negative-predictive values of 89% and 85%, respectively, and was based on four criteria: leakage/staining on FA, retinal thickening, fuzzy area on SD-OCT, and recent metamorphopsia. When excluding FA-derived findings, retinal pigment epithelium (RPE) features played a diagnostic role in 33 eyes (27%). Twenty-seven eyes with active mCNV (32%) did not have the fuzzy area.Taken singularly, no clinical or imaging parameter had both sensitivity and specificity greater than 78%. Matching of 2 or 3 biomarkers did not yield a sensitivity or specificity greater than 79%. Sensitivities and specificities ≥ 90% were found in ten criteria combinations that included four to five biomarkers. The most frequent were metamorphopsia, fuzzy area, retinal thickening, and leakage. Less frequently, they included hemorrhage, staining, and RPE features such as elevation, flattening, and focal interruption.For all the parameters, the agreement between the investigators was good (Cohen k ≥ 0.66), being the lowest when detecting the ELM interruption within the lesion.ConclusionsA combination of at least four clinical and biological markers yielded the highest positive- and negative-predictive values. More (“major”) and less (“minor”) frequent diagnostic criteria are proposed.

Purpose Chest computed tomography (CT) is a fundamental tool for the characterization of acute respiratory distress syndrome (ARDS). Its frequent use is, however, hindered by the associated radiation exposure. The aim of the present study was to evaluate, in patients with ARDS, the accuracy of quantitative and visual anatomical lung analysis performed on low-dose CT. We hypothesized that low-dose CT would provide accurate quantitative and visual anatomical results. Methods Chest CT was performed in 45 ARDS patients in static conditions at set airway pressures of 45 and 15 or 45 and 5 cmH 2 O. During each pause, two consecutive scans were obtained at two different tube current–time products (mAs). In 24 patients 110 mAs was coupled with 60 mAs; in 21 patients 110 was coupled with 30 mAs. All other CT parameters were kept unaltered. Quantitative and visual anatomical results obtained at different mAs were compared via Bland–Altman analysis. Results Good agreements were observed between 110 and 60 mAs and between 110 and 30 mAs both for quantitative and visual anatomical results (all biases below 1.5 %). Estimated mean effective dose at 110, 60, and 30 mAs corresponded to 5.3 ± 1.6, 2.8 ± 0.8, and 1.4 ± 0.3 mSv, respectively. Conclusions In patients with ARDS a reduction of mAs up to 30 (70 % effective dose reduction) can be achieved without significant effect on quantitative and visual anatomical results. Low-dose chest CT, with related quantitative and visual anatomical analysis, could be a valuable tool to characterize and potentially monitor lung disease in patients with ARDS.