Uso de pessários como alternativa ao tratamento cirúrgico de prolapsos genitais

As distopias genitais são uma importante entidade e geralmente se manifestam acompanhadas de queixas urinárias, anorretais e disfunções sexuais, conferindo alta morbidade. Apesar da cirurgia ser considerada padrão-ouro, possui altas taxas de recidiva. O pessário se insere nesse cenário, portanto, como uma alternativa simples e barata para essas pacientes. O objetivo principal do estudo foi avaliar o impacto do uso de pessários na qualidade de vida de mulheres com distopia genital por meio de questionário. Trata-se de um estudo longitudinal prospectivo que teve como critérios de inclusão mulheres com prolapsos genitais graus III e IV com desejo de utilizar o pessário, que estavam na fila de cirurgia, com contraindicação ao procedimento cirúrgico ou sem desejo de realizá-lo. A avaliação da qualidade de vida foi feita por meio de aplicação de questionário validado de qualidade de vida em prolapso, aplicado antes e 3 meses após a inserção do pessário. Ao final, foi obtida uma amostra de 12 mulheres por conveniência. Os valores do questionário antes e depois foram avaliados pelo método de Wilcoxon com p<0,05. Dentre os dados gerais da amostra, tem-se uma média de 78,42 anos e 5,83 partos. A maioria das mulheres apresentaram mais de um fator de risco, sendo menopausa (100%), multiparidade (83%) e parto vaginal (83%) os mais importantes, confirmando uma etiologia multifatorial do prolapso genital. Foi observada uma redução significativa do impacto do prolapso na qualidade de vida dessas mulheres, principalmente nos domínios relacionados ao impacto do prolapso de 87%, emoções de 90%, limitações físicas de 54%, limitações de atividades de 90% e medidas de severidade 88%. A percepção geral de saúde também apresentou melhora significativa do score geral, mesmo na vigência de complicações, como corrimento aumentado (25%), expulsão do dispositivo (16,67%), desconforto (25%) e úlcera (25%), tratadas ambulatorialmente. Os relacionamentos pessoais foram pouco afetados, contraditoriamente à literatura, por conta do viés da maioria ser viúva ou não ter comunicado sobre o prolapso para familiares. Junto a ele, os domínios de sono e energia e limitações sociais, apesar de apresentarem melhora, não houve significância estatística devido à limitação do tamanho da amostra, exigindo estudos adicionais. O uso de pessário vaginal como alternativa ao tratamento cirúrgico de prolapso genital graus III e IV apresentou resultados positivos na qualidade de vida das pacientes portadoras, sendo realidade em outros países. Adicionado a isso, foi constatada a importância da relação médico-paciente para a adesão ao tratamento

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

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