43 research outputs found

    Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial

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    BACKGROUND: Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). METHODS/DESIGN: ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH2O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure 6430 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. DISCUSSION: If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration metho

    Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

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    Background: Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design: ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH(2)O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure <= 30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion: If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method.Hospital do Coracao (HCor) as part of the Program 'Hospitais de Excelencia a Servico do SUS (PROADI-SUS)'Brazilian Ministry of Healt

    Correlation between lid margin meibomian and tear break-up time on subjects stratified by OSDI scores

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    Purpose: To examine the clinical relationship between meibomian lipid secretions (Meibometry) and Break-up time (BUT) using different averaging methods and symptoms cluster analysis assessed by an OSDI questionnaire. Methods: 145 patients who fulfilled the study’s inclusion criteria were recruited for the study. Subjects were stratified following OSDI score. Using Meibometer MB550 under controlled environmental conditions, five curves were generated from the measurement performed on each patient. Curves were averaged using different criteria. BUT measurement was repeated three times to give three videos in each subject. BUT values were determined in frames on video-recordings with software-assisted interpretation and different averaging methods. Results: Cluster analysis on subjects stratified by OSDI scores showed significant correlation between Meibometry results and BUT (all p’ p = 0.029; all r’ 0.196), being more pronounced on symptomatic subjects (from r = 0.443 to r = 0.568). Conclusion: There is relationship between lipids on the lid margin and tear film stability on symptomatic subjects.info:eu-repo/semantics/publishedVersio

    Administración accidental de metamizol por vía epidural

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    The erroneous or accidental epidural administration of substances entails a potential morbidity (1,2) and mortality risk. Once the accident has happened, there is no effective treatment; therefore, prevention and measures aimed to avoid this type of errors are the best and most effective treatment. We present the case of a patient to which an infusion of morphine and metamizol was epidurally administered during approximately 4 hours in PCA programmed for intravenous administration.El riesgo de la administración errónea o accidental de sustancias por vía epidural presenta un potencial riesgo de morbilidad (1,2) y mortalidad Una vez ocurrido el accidente, el tratamiento efectivo no existe, por ello la prevención y medidas encaminadas a evitar estos errores son el mejor y más efectivo tratamiento. Presentamos el caso de una paciente a la que se le administró vía epidural durante aproximadamente 4 horas una perfusión de morfina y metamizol en PCA programada para vía intravenosa

    Inter observer and intraobserver repeatability of lipid layer pattern evaluation by two experienced observers

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    The lipid layer plays a major role in limiting evaporation of the tear film. Based on interference phenomena, there is a test directed to lipid layer pattern (LLP) evaluation, but is affected by subjective interpretation of the patterns. The aim of this study is to compare the LLP evaluation between two experienced observers on a group of healthy patients. Furthermore, the observers re-evaluated the same images in order to check their individual repeatability. LLP was examined using a Tearscope-plus (Keeler, Windsor, UK) attached to a slit lamp. Tear film was ecorded by a Topcon DV-3 digital camera video and LLP images were captured. This yielded 124 LLP images that were categorized (based on Guillon’s schema) by two expert observers in two sessions separated by one month. Interobserver repeatability and intraobserver repeatability between both sessions were studied by using Cohen’s kappa coefficient. Comparing LLP categorization between both observers, Cohen's kappa coefficient was 0.615 and 0.633 for first and second session, respectively. When comparing LLP categorization by the same observer between both sessions, Cohen's kappa coefficient was 0.770 and 0.812 for Observer 1 and Observer 2. These results indicate substantial correlation in all cases [range of 0.61–0.80]. The most frequent misinterpretations were between open and closed meshwork and Wave and closed meshwork patterns. Although substantial correlation was found between categorizations of experienced observers, misinterpretation of the patters may appear even in the same observer. Some misinterpretations between adjacent patterns could be palliated by including intermediate patterns between those categories.This study was funded by the Spanish Ministry of Science and Education and the Instituto de Salud Carlos III through grant PI10/01098.info:eu-repo/semantics/publishedVersio

    Associations between Ocular Biometry, Refractive Error, and Body Characteristics

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    Myopia is a refractive error widely spread throughout the world, usually related to excessive axial length (AL) of the eye. This elongation could have severe consequences, even leading to blindness. However, AL varies among subjects, and it may be correlated with other anthropometric parameters. The aim of this study was to evaluate the relationships between AL, body height, refractive error, and sex. A total of 72 eyes of 36 myopic participants with a mean age of 11.1 ± 1.42 years (ranging from 8 to 14 years) were included in the study. Participants underwent objective refraction by NVision-K5001, AL measurement by Topcon MYAH biometer, and body height measurement. Significant correlations were observed between AL, body height, and spherical equivalent (SE) (Spearman’s correlation, all p ≤ 0.016). When participants were grouped by AL, significant differences were observed for body height and SE, and when grouped by height percentile, significant differences were observed for AL and SE (Kruskal–Wallis test, all p ≤ 0.006). There was a significant difference in SE, AL, and body height between genders (Mann–Whitney U test, all p ≤ 0.038). AL relates to the refractive state of the eye and is also influenced by individual anatomical characteristics

    Comparison between three methods to value lower tear meniscus measured by image software

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    To measure different parameters of lower tear meniscus height (TMH) by using photography with open software of measurement. TMH was addressed from lower eyelid to the top of the meniscus (absolute TMH) and to the brightest meniscus reflex (reflex TMH). 121 young healthy subjects were included in the study. The lower tear meniscus was videotaped by a digital camera attached to a slit lamp. Three videos were recorded in central meniscus portion on three different methods: slit lamp without fluorescein instillation, slit lamp with fluorescein instillation and TearscopeTM without fluorescein instillation. Then, a masked observed obtained an image from each video and measured TMH by using open source software of measurement based on Java (NIH ImageJ). Absolute central (TMH-CA), absolute with fluorescein (TMH-F) and absolute using the Tearscope (TMH-Tc) were compared each other as well as reflex central (TMH-CR) and reflex Tearscope (TMH-TcR). Mean ± S.D. values of TMH-CA, TMH-CR, TMH-F, TMH-Tc and TMH-TcR of 0.209 ± 0.049, 0.139 ± 0.031, 0.222 ± 0.058, 0.175 ± 0.045 and 0.109 ± 0.029 mm, respectively were found. Paired t-test was performed for the relationship between TMH-CA – TMH-CR, TMH-CA – TMH-F, TMH-CA – TMH-Tc, TMH-F – TMH-Tc, TMH-Tc – TMH-TcR and TMH-CR – TMH-TcR. In all cases, it was found a significant difference between both variables (all p < 0.008).info:eu-repo/semantics/publishedVersio

    Tratamiento con esteroides sistémicos en agudización grave de enfermedad pulmonar obstructiva crónica: empleo de pautas cortas en práctica clínica habitual y relación con la estancia hospitalaria

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    [Introduction] It is not known whether clinical practice guidelines for the treatment of COPD exacerbations with short coursesofsystemic corticosteroids(SC-SCS) are followed in clinical practice.[Method] Prospective, observational cohort study in patients admitted due to severe COPD exacerbation. The primary endpoint was the percentage of patients who received SC-SCS as treatment for severe exacerbation (doses of 200-300 mg for 5-6 days). Secondary variables were percentageof patients with duration or reduced dose, dose in the first 24 hours, days of intravenous systemic corticosteroids (SCS), and duration of hospital length of stay (LOS). Simple linear regression was performed with LOS as a dependent variable and multivariate analysis with factors associated with LOS.[Results] 158 patients were evaluated. 4.4% (7) patients received SC-SCS, 8.7% received a reduced dose and duration was reduced in 15.8%. The median dose and duration of SCS were 602.5 mg (200-1625) and 14 (4-36) days, respectively. We observed an association between days of SCSand LOS (P < .001) and doses of intrahospitalSCSand LOS (P < .001). Factors associated with LOS were doses of intrahospitalSCS received (.01 [95% CI:.007-.013]; P < 0.001), days of steroid treatment (.14 [95% CI .03-.25], P = .009) and PAFI (pO2/FiO2 ratio) at admission (-.012 [95% CI: -.012 to -.002], P = .015).[Conclusions] The SCS schedules used in routine clinical practice are longer and administered at a higher dose than recommended, leading toa longer hospital stay.[Introducción] Se desconoce si en la práctica clínica habitual se siguen las recomendaciones de las guías de práctica clínica con respecto al tratamiento de las exacerbaciones de la EPOC con pautas cortas (PC) de corticoesteroides sistémicos (CS).[Método] Estudio de cohortes, prospectivo y observacional en pacientes que ingresan por una agudización grave de su EPOC. La variable principal fue porcentaje de pacientes que recibían PC de CS como tratamiento en la exacerbación grave (dosis acumulada total de 200 a 300 mg y una duración de 5-6 días). Las variables secundarias fueron porcentaje de pacientes con duración o dosis corta, dosis en las primeras 24 horas, días de CS intravenosos y duración de la estancia hospitalaria (EH). Se realizó regresión lineal simple con días de estancia hospitalaria como variable dependiente y análisis multivariante con factores asociados a estancia hospitalaria.[Resultados] Se evaluaron 158 pacientes; 4,4% (7) pacientes recibieron una PC de CS. El 8,7% recibió un tratamiento corto y el 15,8% una duración reducida. La mediana de dosis y duración de CS fue 602,5 mg (rango intercuartílico: 430-850) y 14 (rango intercuartílico: 4-36) días respectivamente. Observamos asociación entre más días de CS y una mayor EH (p < 0,001) y una mayor dosis de CS intrahospitalaria e incremento de EH (p < 0,001).Los factores asociados con EH fueron dosis de CS intrahospitalaria recibida (0,01 [IC 95%: 0,007-0,013]; p < 0,001), días de tratamiento esteroideo (0,14 [IC 95%: 0,03-0,25]; p = 0,009) y PAFI (cociente pO2/FiO2) al ingreso (–0,012 [IC 95%: –0,012 a –0,002]; p = 0,015).[Conclusiones] Las pautas de CS empleadas en la práctica clínica habitual son más prolongadas y a una mayor dosis que las recomendadas, asociando una mayor estancia hospitalaria.Peer reviewe
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