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 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

Impact of COVID-19 on cardiovascular testing in the United States versus the rest of the world

Objectives: This study sought to quantify and compare the decline in volumes of cardiovascular procedures between the United States and non-US institutions during the early phase of the coronavirus disease-2019 (COVID-19) pandemic. Background: The COVID-19 pandemic has disrupted the care of many non-COVID-19 illnesses. Reductions in diagnostic cardiovascular testing around the world have led to concerns over the implications of reduced testing for cardiovascular disease (CVD) morbidity and mortality. Methods: Data were submitted to the INCAPS-COVID (International Atomic Energy Agency Non-Invasive Cardiology Protocols Study of COVID-19), a multinational registry comprising 909 institutions in 108 countries (including 155 facilities in 40 U.S. states), assessing the impact of the COVID-19 pandemic on volumes of diagnostic cardiovascular procedures. Data were obtained for April 2020 and compared with volumes of baseline procedures from March 2019. We compared laboratory characteristics, practices, and procedure volumes between U.S. and non-U.S. facilities and between U.S. geographic regions and identified factors associated with volume reduction in the United States. Results: Reductions in the volumes of procedures in the United States were similar to those in non-U.S. facilities (68% vs. 63%, respectively; p = 0.237), although U.S. facilities reported greater reductions in invasive coronary angiography (69% vs. 53%, respectively; p < 0.001). Significantly more U.S. facilities reported increased use of telehealth and patient screening measures than non-U.S. facilities, such as temperature checks, symptom screenings, and COVID-19 testing. Reductions in volumes of procedures differed between U.S. regions, with larger declines observed in the Northeast (76%) and Midwest (74%) than in the South (62%) and West (44%). Prevalence of COVID-19, staff redeployments, outpatient centers, and urban centers were associated with greater reductions in volume in U.S. facilities in a multivariable analysis. Conclusions: We observed marked reductions in U.S. cardiovascular testing in the early phase of the pandemic and significant variability between U.S. regions. The association between reductions of volumes and COVID-19 prevalence in the United States highlighted the need for proactive efforts to maintain access to cardiovascular testing in areas most affected by outbreaks of COVID-19 infection

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 &lt;= 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

Automedicação em idosos residentes em Campinas, São Paulo, Brasil: prevalência e fatores associados Self-medication in the elderly population of Campinas, São Paulo State, Brazil: prevalence and associated factors

O objetivo foi avaliar a prevalência e fatores associados à automedicação em idosos e identificar os principais fármacos consumidos sem prescrição. Estudo transversal de base populacional, com amostra estratificada por conglomerados e em dois estágios realizado em Campinas, São Paulo, Brasil, em 2008-2009. Dos 1.515 idosos, 80,4% referiram uso de ao menos um medicamento nos três dias anteriores à pesquisa. Desses, 91,1% relataram consumo exclusivo de medicamentos prescritos e o restante (8,9%), uso simultâneo de prescritos e não prescritos. Após ajuste, idade > 80 anos, hipertensão arterial, presença de doenças crônicas, uso de serviços de saúde, realização de consultas odontológicas e filiação a plano médico de saúde estiveram associadas negativamente, e renda per capita, positivamente à automedicação. Os fármacos sem prescrição mais consumidos foram dipirona, AAS, diclofenaco, Ginkgo biloba, paracetamol e homeopáticos. Sobretudo entre idosos, a assistência farmacêutica deve ser priorizada para evitar o uso incorreto de medicamentos e garantir o acesso aos fármacos necessários ao tratamento.<br>The aim of this study was to evaluate the prevalence and causative factors associated with self-medication in the elderly and identify the main drugs consumed without prescription. A cross-sectional population-based study with stratified clustered two-stage sampling was performed in Campinas, São Paulo, Brazil in 2008 and 2009. Of the 1,515 elderly studied, 80.4% reported using at least one drug duringthe three days preceding the survey. Of these, 91.1% reported the use of prescription drugs only and the remainder (8.9%) reported simultaneous use of prescribed and non prescribed drugs. After adjustment, a negative association between age > 80 years, hypertension, chronic diseases, use of health services, dental consultations and adherence to a medical plan,and self-medication was found, whereas a positive association was found with per capita income. Dipyrone, acetylsalicylic acid, diclofenac, Ginkgo biloba, paracetamol and homeopathic medicines were among the most used non-prescribed drugs. Pharmaceutical assistance should be provided as a priority tothe elderly, to avoid the misuse of medicines and ensure access to the correct drugs

Transpiração em espécie de grande porte na Floresta Nacional de Caxiuanã, Pará Transpiration in large size species in Caxiuanã National Forest, in the State of Pará, Brazil

Durante o experimento "O Impacto da Seca Prolongada nos Fluxos de Água e Dióxido de Carbono em uma Floresta Tropical Amazônica" (ESECAFLOR) realizou-se este trabalho. Trata-se de um subprojeto do Experimento de Grande escala da Biosfera-Atmosfera da Amazônia (LBA), localizado na Estação Científica Ferreira Pena, dentro da Floresta Nacional de Caxiuanã, Pará (1º 42- 30-- S; 51º 31-45-- W; 62 m altitude). A região tem floresta bem preservada, com dossel médio de 35 m. As espécies predominantes em terra-firme, são: Eschweilera coriacea (Mata-matá branco), Voucapoua americana (Acapu) e Protium pallidum (Breu Branco). Medidas foram realizadas entre 03 a 16 de dezembro de 2000 e 12 a 25 de janeiro de 2003, objetivando-se determinar a transpiração de dois exemplares de Eschweilera coriacea, mediante os efeitos da seca provocada. A área do ESECAFLOR compreende duas parcelas, cada uma com 1 ha, parcela A (controle) e parcela B (exclusão da chuva). Para o fluxo de seiva, o método foi o Balanço de Calor no Tronco, com sistema Sap Flow meter, P4.1; entre os períodos analisados, a transpiração média registrou aumento de 56% na árvore A237 (parcela A) e redução de 68% na árvore B381 (parcela B).<br>During the "Long-term impact of drought on water and carbon dioxide fluxes in Amazonian Tropical Rainforest Experiment" (ESECAFLOR), this study was carried out, which is a subproject of Large Scale Biosphere Atmosphere Experiment in Amazônia (LBA), located in the Ferreira Penna Scientific Station (FPSS) in the Caxiuanã National Forest (CNF) in Pará State (1º 42- 30-- S; 51º 31-45-- W; 62 m altitude). The region has a well-preserved forest, with canopy of 35 m. The predominate tree species in the landscape are Eschweilera coriacea (White Matá-matá), Voucapoua americana (Acapu) and Protium pallidum (White Pitch). Sap flow measurements were made in the wet season (03-16 December 2000 and 12-25 January 2003), to evidence the effect of long term induced drought, aiming to determinate the transpiration of Eschweilera coriacea. The ESECAFLOR site consists of two different areas with 1 ha each. Plot A (control) and Plot B (rainfall exclusion). The Trunk Heat Balance (THB) method was applied to sap flow measurements, by Sap Flow Meter P4.1 system. Between analysed periods, the mean transpiration of E. Coriacea increased 56% in the tree A237 (control plot) and decreased 68% in B381 (drought plot)