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

Avaliação perinatal de gestações com insuficiência placentária grave

Made available in DSpace on 2014-07-22T13:16:48Z (GMT). No. of bitstreams: 2 Paulo Roberto Nassar de Carvalho.pdf: 1367198 bytes, checksum: 82ff68926d463d4b77b29baf25d51022 (MD5) license.txt: 1914 bytes, checksum: 7d48279ffeed55da8dfe2f8e81f3b81f (MD5) Previous issue date: 2011Fundação Oswaldo Cruz. Instituto Fernandes Figueira. Departamento de Ensino. Programa de Pós-Graduação em Saúde da Criança e da Mulher. Rio de Janeiro, RJ, Brasil.A avaliação gestacional e no período pós-parto de gestações acometidas por insuficiência placentária grave e de início precoce constitui a principal temática dessa Tese. A nossa população é formada por gestantes e fetos prematuros com alterações de fluxo sanguíneo identificadas ao Doppler entre 24 e 33 semanas de idade gestacional, constituindo uma coorte de estudo iniciada em 2002 (e que continua em andamento). Para avaliarmos elementos relacionados à predição de parâmetros de morbiletalidade perinatal, optamos por dividir os objetivos em duas etapas, cada qual apresentada distintamente no formado de um artigo científico. O primeiro artigo se propõe a avaliar o desempenho do SNAPPE-II como preditor de gravidade pós-natal em uma amostra de recém nascidos (RN) prematuros com alto-risco para asfixia. Apesar de ser um escore de avaliação de risco amplamente utilizado na neonatologia, o SNAPPE-II ainda não havia sido testado especificamente em uma população com as características da nossa. A construção de curvas ROC (Receiver Operating Characteristics) para mortalidade e complicações neonatais adversas, definidas como: hemorragia periventricular-intraventricular graus 3 ou 4; retinopatia da prematuridade estádios 3 ou 4; leucomalácia periventricular e broncodisplasia pulmonar mostrou a efetividade do SNAPPE-II em 86 RN prematuros com Doppler alterado. A segunda etapa dessa Tese corresponde a avaliação do desempenho da fórmula de estimativa de peso fetal (EPF), desenvolvida por Hadlock et al., comparando a EPF da última ultrassonografia gestacional com o peso ao nascimento. Até onde alcança nossos conhecimentos, o presente estudo foi o primeiro na América Latina a avaliar a utilização da referida fórmula em uma amostra altamente seletiva de fetos prematuros por insuficiência placentária grave. Cem fetos foram estudados. Análise descritiva, correlação de Pearson e teste de Cronbach foram relizados. O erro médio absoluto (EMA) foi comparado com zero utilizando-se o teste-t , sendo encontrado um valor de 14.2 ± 9.1% para toda a coorte estudada. Um EMA de 22,8 ± 15,5% foi encontrado para o grupo de fetos com crescimento normal e de 8.0 ± 10.9% para aqueles com crescimento intrauterino restrito. Não houve diferença significativa entre os grupos. Concluímos que a fórmula de Hadlock et al. tem uma boa acurácia na EPF em gestações com insuficiência placentária grave e de início precoce.The main subject of this Thesis is the perinatal assessment of pregnancies affected by severe placental insufficiency of early onset. Our population consists of pregnant women and preterm fetuses with abnormal blood flow Doppler identified between 24 and 33 weeks of gestation age. This cohort was initiated in 2002 and is still in progress. To evaluate factors related to the prediction of perinatal mortality and morbidity, we divided the objectives of this Thesis into two stages, displayed in two scientific articles. The first article proposes to evaluate the performance of SNAPPE-II as a predictor of postnatal severity in a sample of newborns (NB) at high risk for asphyxia. Although be a risk assessment score widely used in neonatology, the SNAPPE-II had not yet been tested specifically in a population with ours characteristics. The ROC curves (Receiver Operating Characteristics) for mortality and adverse neonatal outcome (ANO) demonstrated the effectiveness of SNAPPE-II in the prediction of 86 premature NB with altered Doppler. ANO was defined as periventricularintraventricular hemorrhage; (2) retinopathy of prematurity stage 3 or 4; (3) periventricular leukomalacia; (4) bronchopulmonary dysplasia; (5) necrotizing enterocolitis. The second stage of this thesis proposes to evaluate the performance of Hadlock et al. formula for estimating fetal weight (EFW) comparing with birth weight. This study was the first in Latin America to assess the use of this formula in a highly selective sample of preterm fetuses with severe placental insufficiency. One hundred fetuses were studied. Descriptive analysis, Pearson correlation and Cronbach's test were employed. The mean absolute error (MAE) was compared with zero using t-test. A value of 14.2 ± 9.1% was found for the entire cohort. A MAE of 22.8 ± 15.5% was found for the group of fetuses with normal growth and 8.0 ± 10.9% for those with intrauterine growth restriction. There was no significant difference between groups. We conclude that the Hadlock’s formula has a high accuracy in the EFW in pregnancies with severe placental insufficiency of early onset

Dopplerfluxometria de ducto venoso: identificação não invasiva da acidemia em fetos prematuros centralizados Ductus venosus velocimetry: noninvasive identification of fetal acidemia in preterm fetuses with brain sparing reflex

OBJETIVO: estabelecer o ponto de corte a partir do qual seja possível identificar fetos prematuros com centralização do fluxo sangüíneo que apresentem gasometria anormal. MÉTODO: foi realizado estudo observacional transversal, cuja população consistia de 60 gestantes com fetos centralizados (relação umbílico-cerebral maior que 1), com idade gestacional entre 25 e 33 semanas. O ducto venoso foi identificado com auxílio da dopplerfluxometria colorida e obtida a relação S/A a partir do sonograma (relação entre a velocidade de pico da sístole ventricular e a velocidade de pico da sístole atrial). Imediatamente após a cesariana foi colhida amostra de sangue da veia umbilical para gasometria. Os conceptos foram classificados de acordo com a análise gasométrica e considerados anormais quando pH OBJECTIVE: to assess through Dopllerfluxometry the S/A ratio of the ductus venosus and determine the cut-off point to identify preterm fetuses with the 'brain sparing phenomenon". METHOD: a cross-sectional study was performed in 60 pregnant women that presented the "brain sparing phenomenon" (umbilical cerebral ratio >1) and gestational age between 25 and 33 weeks. The following parameters were studied: S/A ratio of the ductus venosus, pH and base excess (BE) of a fetal blood sample collected from the umbilical vein immediately after birth. The fetuses were classified according to the gas analysis result. They were considered abnormal when pH <7.20 and BE < -6 mmol/l. A receiver operator characteristic (ROC) curve analysis was performed to examine the relationship between S/A ratio and fetal acidemia. RESULTS: sixty pregnant women in the period of January 1998 to January 2003 were selected. In the moment of the study the gestational age varied from 25 to 33 weeks, with an average of 29.7 weeks (±1.8 weeks). All of the fetuses presented the "brain sparing phenomenon". Among them 14 presented abnormal gas analysis at birth and 46 presented normal gas analysis. The prevalence of fetuses with abnormal gas analysis in the studied material was 23.33%. Significant association was observed between the abnormal ductus venosus velocimetry and abnormal gas analysis at birth (chi2 = 784.44, p < 0.00001) in preterm fetuses with "brain sparing phenomenon". The best cut-off point of the S/A ratio (where the ROC curves bent) was 3.4. CONCLUSION: fetal acidemia in preterm fetuses with "brain sparing phenomenon" may be noninvasively identified by Doppler measurement of the ductus venosus when the S/A rises above 3.4

Is intrauterine surgery justified? Report from the working group on ultrasound in obstetrics of the World Association of Perinatal Medicine (WAPM)

Fetal surgery involves a large number of heterogeneous interventions that vary from simple and settled procedures to very sophisticated or still-in-development approaches. The overarching goal of fetal interventions is clear: to improve the health of children by intervening before birth to correct or treat prenatally diagnosed abnormalities. This article provides an overview of fetal interventions, ethical approaches in fetal surgery, and benefits obtained from antenatal surgeries

Doppler velocimetry of ductus venous in preterm fetuses with brain sparing effect: neonatal outcome

Objective: to evaluate the relationship between ductus venous (DV) and Doppler velocimetry in neonatal outcome in severe compromised preterm fetuses. Methods: the study was designed as an observational and cross-sectional study with 52 premature neonates with brain sparing effect. The criteria of neonatal severe morbidity were: severe intraventricular hemorrhage (grades 3 or 4), retinopathy of prematurity (grade 3 or 4), cystic periventricular leukomalatia, bronchopneumo dysplasia and neonatal mortality. The fetuses were divided in two groups: group 0 - all the fetuses with ventricular systole/atrial contraction (S/A) in DV ratio values less them 3.4; group 1 - fetuses with values of S/A ratio greater than 3.4. Results: 42% of fetuses showed abnormal S/A ratio in DV and 48% showed birth weight below percentile 3 for gestational age. There was no statistical significance comparing the 02 groups according to bronchopneumo dysplasia, retinopathy of prematurity (grade 3 or 4) and intraventricular hemorrhage (grade 3 or 4). Only one fetus presented cystic periventricular leukomalatia. We found statistically significant association between abnormal DV S/A ratio and neonatal mortality (CI 95%, 1.28 -38.22, p< 0.002). Conclusions: our results suggest that abnormal DV blood flow detected by Doppler examination isnʼt associated with severe neonatal morbidity but with neonatal mortality