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

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

Relação da presença de hiperacusia em pacientes com paralisia facial periférica de Bell Relation of hyperacusis and peripheral facial paralysis - Bell's palsy

A paralisia de Bell é uma paralisia facial unilateral de início súbito e de causa desconhecida. Pode afetar a salivação, o paladar e o lacrimejamento dependendo do topografia do acometimento do nervo facial, e os pacientes podem referir hipersensibilidade auditiva. Nos pacientes com paralisia de Bell, o reflexo estapediano está ausente. OBJETIVO: O objetivo desta investigação foi o de verificar se os pacientes com paralisia de Bell apresentam hiperacusia. FORMA DE ESTUDO: Clínico prospectivo. MATERIAL E MÉTODO: Foram examinados 18 pacientes aleatórios apresentando paralisia facial periférica de Bell. Foi realizada avaliação otorrinolaringológica completa, teste de Hilger, teste de Schirmer, gustometria, audiometria tonal e vocal, imitanciometria e teste de desconforto auditivo. A faixa etária entre 31 e 40 anos foi a mais afetada pela PFP nesta amostra. RESULTADO: Os pacientes do sexo feminino foram os mais afetados estando acometidos em 61% dos casos. A hemi-face direita foi acometida em 56% dos casos. O grau de acometimento local mais encontrado foi o grau IV em 44% dos casos e os graus III e V em 28% dos casos cada. A queixa de hiperacusia esteve presente em apenas um paciente, o que representa 5,5% dos casos. Todos os pacientes estudados apresentaram diminuição nos gráficos audiométricos do limiar de tolerância auditiva, sendo que o reflexo estapediano protege, em média 16 dB, nestes pacientes. CONCLUSÃO: Portanto, concluímos que pacientes com paralisia de Bell apresentam clinicamente queixas de hiperacusia semelhantes da população geral, porém, audiometricamente, o limiar de tolerância auditivo no lado paralisado é menor do que em relação ao do lado normal.<br>Bell's palsy is a unilateral facial paralysis of sudden onset and unknown cause. It may affect salivation, taste and lachrymation depending on the site of facial nerve involvement. Patients can report supersensitive hearing. The stapedius reflex is absent in patients with Bell's palsy. AIM: The objective of the present study was to check if patients with Bell's palsy present hyperacusis. STUDY DESIGN: Clinical prospective. MATERIAL AND METHOD: Eighteen patients with peripheral facial paralysis were randomly selected and examined. Complete ENT evaluation was performed, including Hilger facial nerve stimulator, Schirmer's test, electrogustometry, pure tone testing, speech audiometry, immittance testing and discomfort loudness levels. The group aged 31-40 years was the most affected by peripheral facial paralysis in this sample. RESULTS: The incidence was higher in females (61%). The right side of the face was involved in 56% of patients. As to local involvement, grade IV was observed in 44% of cases and grades III and V in 28% of patients each. Only one patient (5.5%) complained of hyperacusis. All studied patients presented reduced tolerance threshold in the audiometric graphs, and stapedius reflex protects these patients by 16dB on average. CONCLUSION: Therefore, we could conclude that the frequency of complaints of hyperacusis in patients with Bell's palsy was similar to that of the general population; however, in audiometric terms, the tolerance threshold in the paralyzed side was lower when compared with the normal side

Contribution of audiovestibular tests to the topographic diagnosis of sudden deafness

Introduction: Sudden hearing loss (SHL) is an ENT emergency defined as sensorineural hearing loss (SNHL) ≥ 30 dB HL affecting at least 3 consecutive tonal frequencies, showing a sudden onset, and occurring within 3 days. In cases of SHL, a detailed investigation should be performed in order to determine the etiology and provide the best treatment. Otoacoustic emission (OAE) analysis, electronystagmography (ENG), bithermal caloric test (BCT), and vestibular evoked myogenic potential (VEMP) assessments may be used in addition to a number of auxiliary methods to determine the topographic diagnosis. Objective: To evaluate the contribution of OAE analysis, BCT, VEMP assessment, and magnetic resonance imaging (MRI) to the topographic diagnosis of SHL. Method: Cross-sectional and retrospective studies of 21 patients with SHL, as defined above, were performed. The patients underwent the following exams: audiometry, tympanometry, OAE analysis, BCT, VEMP assessment, and MRI. Sex, affected side, degree of hearing loss, and cochleovestibular test results were described and correlated with MRI findings. Student's t-test was used for analysis of qualitative variables (p < 0.05). Results: The mean age of the 21 patients assessed was 52.5 ± 15.3 years; 13 (61.9%) were women and 8 (38.1%) were men. Most (55%) had severe hearing loss. MRI changes were found in 20% of the cases. When the audiovestibular test results were added to the MRI findings, the topographic SHL diagnosis rate increased from 20% to 45%. Conclusion: Only combined analysis via several examinations provides a precise topographic diagnosis. Isolated data do not provide sufficient evidence to establish the extent of involvement and, hence, a possible etiology

Formação de cisto epidermóide (colesteatoma) com implantação de tecido epitelial junto ao osso femural de ratos Growth of cholesteatoma by implantation of epithelial tissue along the femoral bone of rats

O colesteatoma é um cisto epidermóide, caracterizado por tecido epidérmico queratinizado, com capacidade de migração e erosão de estruturas adjacentes. OBJETIVO: Verificar o crescimento do cisto epidermóide (colesteatoma) quando se implanta fragmento de pele do pavilhão auricular junto ao osso femoral de ratos. FORMAL DE ESTUDO: experimental. MATERIAL E MÉTODO: Foram selecionados 10 ratos, os quais foram submetidos à implantação de fragmento de pele do pavilhão auricular na coxa e mantidos por 3 meses, seguido de remoção do tecido implantado após este período. Cada fragmento ressecado dos animais foi incluso em parafina, corado em hematoxilina-eoxina e preparado em lâminas para efetivação de estudo anatomopatológico. RESULTADO: Aspecto macroscópico: aspecto granulomatoso, de coloração amarelada, de forma arredondada e amolecida. Aspecto microscópico: estrutura cística com revestimento constituído por epitélio escamoso estratificado. O cisto apresenta camada mais interna córnea, com descamação de queratina, seguida da camada granulosa e camadas escamosa e basal mais externamente. CONCLUSÃO: O cisto epidermóide (colesteatoma) pode se desenvolver a partir de tecido epitelial transplantado junto ao osso femoral de ratos.<br>Cholesteatoma is a well-known infection resembling a pearl. Its histological aspect is of an epidermal cyst formation characterized by epidermal-keratinized tissue in the middle ear and mastoid that can migrate and erode to adjacent structures. AIM: To verify epidermal cyst (cholesteatoma) growth through implantation of auricular skin of a mouse next to its femoral bone. STUDY DESIGN: experimental. MATERIAL AND METHOD: Ten healthy rats between two and five months of age and of both sexes underwent implantation of auricular skin on the femoral bone during a three-month period. Paraffin-embedded sections were obtained from the sample and stained with hematoxylin and eosin for pathology investigation. RESULTS: Macroscopic view: round soft yellowish granulation tissue. Microscopic view: keratinizing stratified squamous epithelium cystic formation. The cyst presented innermost corneal layer, resulted from keratinized skin, followed by granulated and squamous layers, and outermost basal layer. CONCLUSIONS: Growth of epidermal cyst (cholesteatoma) may start from a transplanted epithelial tissue next to the femoral bone of rats

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

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.13Hospital do Coracao (HCor) as part of the Program 'Hospitais de Excelencia a Servico do SUS (PROADI-SUS)'Brazilian Ministry of Healt

NEOTROPICAL ALIEN MAMMALS: a data set of occurrence and abundance of alien mammals in the Neotropics

Biological invasion is one of the main threats to native biodiversity. For a species to become invasive, it must be voluntarily or involuntarily introduced by humans into a nonnative habitat. Mammals were among first taxa to be introduced worldwide for game, meat, and labor, yet the number of species introduced in the Neotropics remains unknown. In this data set, we make available occurrence and abundance data on mammal species that (1) transposed a geographical barrier and (2) were voluntarily or involuntarily introduced by humans into the Neotropics. Our data set is composed of 73,738 historical and current georeferenced records on alien mammal species of which around 96% correspond to occurrence data on 77 species belonging to eight orders and 26 families. Data cover 26 continental countries in the Neotropics, ranging from Mexico and its frontier regions (southern Florida and coastal-central Florida in the southeast United States) to Argentina, Paraguay, Chile, and Uruguay, and the 13 countries of Caribbean islands. Our data set also includes neotropical species (e.g., Callithrix sp., Myocastor coypus, Nasua nasua) considered alien in particular areas of Neotropics. The most numerous species in terms of records are from Bos sp. (n = 37,782), Sus scrofa (n = 6,730), and Canis familiaris (n = 10,084); 17 species were represented by only one record (e.g., Syncerus caffer, Cervus timorensis, Cervus unicolor, Canis latrans). Primates have the highest number of species in the data set (n = 20 species), partly because of uncertainties regarding taxonomic identification of the genera Callithrix, which includes the species Callithrix aurita, Callithrix flaviceps, Callithrix geoffroyi, Callithrix jacchus, Callithrix kuhlii, Callithrix penicillata, and their hybrids. This unique data set will be a valuable source of information on invasion risk assessments, biodiversity redistribution and conservation-related research. There are no copyright restrictions. Please cite this data paper when using the data in publications. We also request that researchers and teachers inform us on how they are using the data