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

Evaluation of depression and anxiety symptoms, alcohol consumption, and binge eating in older adults undergoing bariatric surgery: a 6-year follow-up

INTRODUCTION: The literature remains scarce on the late effects of bariatric surgery on the general health of patients who underwent such procedures at an older age. The present study aimed to evaluate depression and anxiety symptoms, risky alcohol consumption, and binge eating in older adults undergoing bariatric surgery. METHODS: This study used current data (from medical records and tests) to conduct a cross-sectional study. A total of 74 individuals aged 60 years and older who underwent bariatric surgery after 55 years of age at a specialist center for obesity management located in Brazil were included and evaluated by the Beck Depression Inventory, Beck Anxiety Inventory, Alcohol Use Disorders Identification Test, and Binge Eating Scale. Demographic and clinical data related to the surgical procedure (weight loss) were also collected. The Cochran-Armitage trend test, Pearson’s \u3c72 test, and a multiple linear regression model were used as needed. A p &lt; 0.05 was considered significant. RESULTS: The individuals were white (65.70%) and women (78.30%), with a mean age of 65.8 (SD 3.90) years. The mean time elapsed from surgery to evaluation was 75.70 (SD 43.70) months; 10.80% of the participants had moderate to severe depression, 8.10% moderate to severe anxiety, and 5.40% risky or high-risk alcohol consumption. None of the participants had binge eating problems. Weight regain was not associated with depressive symptom severity or risky alcohol consumption, but it was significantly associated (p = 0.034) with few or neither anxiety symptoms. Excess weight loss was not associated with any study variable. CONCLUSION: The results show a low prevalence of mental symptoms in older adults undergoing bariatric surgery compared to data from the literature on younger adults undergoing the same procedure.</p

Bariatric surgery as a safe and effective intervention for the control of comorbidities in older adults

INTRODUCTION: In addition to being associated with worsening of diseases related to metabolic syndrome and musculoskeletal disorders, obesity in older adults increases the risk of falls, frailty syndrome, depression, and dementia, with consequent functional loss. Among all treatments available, bariatric surgery is an option for eligible patients. OBJECTIVES: To discuss aspects related to the safety and benefits of bariatric surgery for the control or remission of comorbidities in older adults. METHODS: This literature review was carried out in databases, using the following keywords: bariatric surgery and elderly or aged or older adult and comorbidities or safety. We included clinical trials, observational studies, comparative studies, and reviews that evaluated the effect of bariatric surgery on the control or remission of comorbidities in older adults. RESULTS: In recent years, several studies have evidenced not only control or remission of comorbidities, such as diabetes, hypertension, and sleep apnea syndrome, but also a low rate of complications, similar to those observed in young people. CONCLUSIONS: Based on the results of these studies, bariatric surgical procedures can be indicated for eligible older adults, without age restriction, taking into account functional and life expectancy aspects.</p

A influência do genótipo da ECA sobre a aptidão cardiovascular de jovens do sexo masculino moderadamente ativos

FUNDAMENTO: O gene da enzima conversora de angiotensina (gene ECA) tem sido amplamente estudado em relação a fenótipos de aptidão cardiorrespiratória, contudo a associação do genótipo da ECA com corridas de meia-distância tem sido pouco investigada. OBJETIVO: O presente estudo investigou a possível influência da enzima conversora de angiotensina (ECA) (I/D) sobre a aptidão cardiovascular e o desempenho em corridas de meia-distância por parte de brasileiros jovens do sexo masculino. A validade da previsão de VO2max em relação ao genótipo da ECA também foi analisada. MÉTODOS: Um grupo homogêneo de homens jovens moderadamente ativos foi avaliado em um teste de corrida (V1600 m; m.min-1) e em um teste adicional em esteira ergométrica para a determinação de VO2max. Posteriormente, o [(0,177*V1600m) + 8.101] VO2max real e previsto foi comparado com os genótipos da ECA. RESULTADOS: O VO2max e V1600m registrados para os genótipos DD, ID e II foram 45,6 (1,8); 51,9 (0,8) e 54,4 (1,0) mL.kg-1.min-1 e 211,2 (8,3); 249,1 (4,3) e 258,6 (5,4 ) m.min-1, respectivamente e foram significativamente mais baixos para os genótipos DD (p < 0,05). O VO2max real e previsto não diferiram entre si, apesar do genótipo da ECA, mas o nível de concordância entre os métodos de VO2max real e estimado foi menor para o genótipo DD. CONCLUSÃO: Concluiu-se que existe uma possível associação entre o genótipo da ECA, a aptidão cardiovascular e o desempenho em corridas de média distância de jovens do sexo masculino moderadamente ativos e que a precisão da previsão do VO2max também pode ser dependente do genótipo da ECA dos participantes.Background: The angiotensin I-converting enzyme gene (ACE gene) has been broadly studied as for cardiorespiratory fitness phenotypes, but the association of the ACE genotype to middle-distance running has been poorly investigated.Objective: This study investigated the possible influence of Angiotensin-Converting Enzyme (ACE) genotype (I/D) on cardiovascular fitness and middle-distance running performance of Brazilian young males. The validity of VO2max prediction with regard to the ACE genotype was also analyzed.Methods: A homogeneous group of moderately active young males were evaluated in a 1,600 m running track test (V1600m; m.min(-1)) and in an incremental treadmill test for VO2max determination. Subsequently, the actual and the predicted [(0.177*V1600m) + 8.101] VO2max were compared to ACE genotypes.Results: The VO2max and V1600m recorded for DD, ID and II genotypes were 45.6 (1.8); 51.9 (0.8) and 54.4 (1.0) mL.kg(-1). min(-1) and 211.2 (8.3); 249.1 (4.3) and 258.6 (5.4) m.min(-1) respectively, and were significantly lower for DD carriers (p< 0.05). The actual and predicted VO2max did not differ from each other despite ACE genotype, but the agreement between actual and estimated VO2max methods was lower for the DD genotype.Conclusion: It was concluded that there is a possible association between ACE genotype, cardiovascular fitness and middle-distance running performance of moderately active young males and that the accuracy of VO2max prediction may also depend on the ACE genotype of the participants.Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES

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