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

Analysis of maternal confidence for breastfeeding and duration of exclusive breastfeeding among lactating adolescents

A prática do aleitamento materno e seus benefícios para a saúde materno-infantil tem sido alvo de muitos estudos científicos. Apesar das evidências de benefícios, há a necessidade de se ampliar a visão sobre as questões que envolvem a amamentação, compreendendo este processo como multifatorial. Assim, a idade materna é um dos fatores que influenciam a amamentação, pois mães adolescentes podem apresentar maiores dificuldades para início e manutenção desta prática. Além disso, a confiança materna tem sido identificada como uma variável modificável e protetiva no que tange ao aleitamento materno, já que influencia no seu início, adesão e manutenção. Assim, os objetivos deste estudo foram: verificar a confiança materna para amamentar entre mães adolescentes; identificar a prevalências do aleitamento materno exclusivo nos intervalos de 30, 60 e 180 dias de vida; verificar a associação entre a confiança materna das adolescentes para amamentar e a duração do aleitamento materno exclusivo, nos intervalos de 30, 60 e 180 dias pós-parto. Trata-se de um estudo longitudinal prospectivo, observacional e analítico, realizado no alojamento conjunto do CRSM-MATER, no município de Ribeirão Preto/ SP. A coleta de dados foi realizada entre em janeiro de 2014 a junho de 2015. A amostra foi constituída por 160 mães adolescentes. Para coleta de dados, foram aplicados um questionário sobre informações sociodemográficas e obstétricas e o instrumento Breastfeeding Self-Efficacy Scale (BSES) entre as mães adolescentes admitidas no alojamento conjunto. Posteriormente, estas adolescentes foram acompanhadas por meio de busca fonada em 30, 60 e 180 dias pós-parto, com a utilização do terceiro instrumento de coleta de dados, com questões referentes à alimentação oferecida à criança e intercorrências durante o período de amamentação. Os dados foram analisados com a utilização do programa estatístico Statistical Analysis System SAS® 9.0. Para caracterizar a amostra, a análise dos dados foi fundamentada na estatística descritiva. Para verificar a relação entre a confiança materna e os tempos de amamentação foi realizada a análise de variância (ANOVA) e o Coeficiente de Correlação de Pearson. Para verificar a associação entre as variáveis qualitativas, os dados foram submetidos ao Teste Exato de Fisher. Para todas as análises estatísticas, foram considerados nível de significância de 5%. A maioria das participantes (56,90%) apresentou alto nível de confiança para amamentar. A prevalência do aleitamento materno exclusivo foi de 62% nos 30 dias pós-parto, 52,59% nos 60 dias e 16% aos 180 dias pós-parto. Não houve associação estatisticamente significativa entre a confiança da adolescente com a duração do aleitamento materno exclusivo. Houve associação estatisticamente significativa entre a confiança e as variáveis \"intercorrência na gestação\" (p=0,0069) e \"intercorrência no trabalho de parto e/ou parto\"(p=0,0316), ou seja, as adolescentes que não tiveram nenhuma intercorrência na gestação ou no trabalho de parto e/ou parto apresentaram maior confiança na amamentação. Conclui-se que a confiança elevada não foi um fator preditivo da prevalência do AME entre as mães adolescentes, porém foram identificados fatores que influenciaram na confiança para amamentar. Assim, ressalta- se a importância de sua análise na prática clínica com o intuito de fornecer subsídios que favoreçam a melhoria dos índices de amamentação e, consequentemente, da saúde materno- infantilThe practice of breastfeeding and its benefits for maternal and child health has been the subject of many scientific studies. Despite the evidence of benefits, there is the need to expand the vision of the issues surrounding breastfeeding, understanding this process as multifactorial. Thus, maternal age is one of the factors that influence breastfeeding, as teenage mothers may have greater difficulty in initiation and maintenance of this practice. In addition, maternal confidence has been identified as a modifiable and protective variable in relation to breastfeeding, as it influences the beginning, adhesion and maintenance. The objectives of this study were to verify the mother\'s confidence in breastfeeding among teenage mothers; identify the prevalence of exclusive breastfeeding in the ranges of 30, 60 and 180 days of life; verify the association between maternal breastfeeding confidence to the adolescents and duration of exclusive breastfeeding, in intervals of 30, 60 and 180 days postpartum. This is a prospective longitudinal, observational and analytical, held at the rooming CRSM-MATER, in Ribeirão Preto / SP. Data collection was conducted from January 2014 to June 2015. The sample consisted of 160 nursing mothers adolescents. For data collection, they were applied a questionnaire on sociodemographic and obstetrical information and the Breastfeeding Self- Efficacy Scale tool (BSES) among adolescent mothers admitted to the rooming. Subsequently, these adolescents were accompanied by search in 30, 60 and 180 days postpartum, using the third data collection instrument, with questions relating to food offered to children and complications during the breastfeeding period. Data were analyzed using the statistical program Statistical Analysis System SAS® 9.0. To characterize the sample, the analysis was based on descriptive statistics. To investigate the relationship between maternal confidence and breastfeeding times was performed by analysis of variance (ANOVA) and Pearson\'s correlation coefficient. To determine the association between the qualitative variables, the data were submitted to Fisher\'s exact test. For all statistical analyzes were considered 5% significance level. Most participants (56.90%) showed a high level of confidence to breastfeed. The prevalence of exclusive breastfeeding was 62% within 30 days postpartum, 52.59% in 60 days and 16% at 180 days postpartum. There was no statistically significant association between adolescent trust with the duration of exclusive breastfeeding. There was a statistically significant association between the trust and the variables \"complications during pregnancy\" (p = 0.0069) and \"complications during labor and / or childbirth\" (p = 0.0316), that is, the teenagers who did not have no complications during pregnancy or labor and / or delivery showed greater confidence in breastfeeding. It is concluded that the high confidence was not a predictor of the prevalence of exclusive breastfeeding among teenage mothers, but were identified factors that influenced the confidence to breastfeed. Thus, we emphasize the importance of his analysis in clinical practice in order to provide subsidies to encourage the improvement of breastfeeding rates and consequently maternal and child healt

COMPARAÇÃO DA AUTOEFICÁCIA NA AMAMENTAÇÃO ENTRE PUÉRPERAS ADOLESCENTES E ADULTAS EM UMA MATERNIDADE DE RIBEIRÃO PRETO, BRASIL

Objetivo: verificar y comparar la autoeficacia de la Lactancia Materna entre puérperas adolescentes y adultas en el posparto inmediato. Método: estudio observacional, transversal y comparativo, realizado en el alojamiento conjunto de una maternidad, en la ciudad de Ribeirão Preto, Brazil. La recolección de datos fue realizada en el período de enero a julio de 2014. La muestra fue constituida por 306 madres adultas y 94 adolescentes. La versión brasileña de la B reastfeeding Self-Efficacy Scale evaluó la autoeficacia de la lactancia materna. Para comparar los valores de autoeficacia entre los grupos participantes, los valores fueron sometidos al test de t-Student . Fue considerado un nivel de significancia de 5% ( p =0,05). Resultados: entre los grupos participantes la mayoría (54%) presentó niveles elevados de autoeficacia, y la diferencia entre los resultados entre adolescentes y adultos no fue estadísticamente significativo ( p =0,3482). Conclusión: los profesionales deben de estar atentos a la autoeficacia en el amamantamiento, con el objetivo de direccionar acciones específicas a los grupos de mujeres adolescentes y adultas, favoreciendo así, el aumento de los índices de amamantamiento

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