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

Effects of physical therapy with neuromuscular electrical stimulation in the acute and late septic shock patients. Randomised crossover clinical trial

Introdução: Pacientes com sepse e imobilismo na unidade de terapia intensiva estão associados à fraqueza muscular, e a mobilização precoce pode amenizá-la. Entretanto, durante choque séptico, a mobilização é muitas vezes postergada devido à gravidade da doença. A estimulação elétrica neuromuscular pode ser uma alternativa para mobilizar esses pacientes precocemente. Objetivo: O objetivo deste estudo é avaliar se a estimulação elétrica neuromuscular realizada em pacientes em choque séptico nas primeiras 72 horas do diagnóstico do choque séptico e em pacientes em sepse e choque séptico após as 72 horas do diagnóstico é segura metabolicamente e fisiologicamente. Materiais e Métodos: Esta é uma análise de dois ensaios clínicos aleatorizados tipo crossover. Pacientes em choque séptico (dentro das primeiras 72 horas do diagnóstico) e em sepse e choque séptico na fase tardia (após 72 horas de diagnóstico) foram elegíveis. Os pacientes foram submetidos em ordem aleatória ao protocolo de intervenção (posição de decúbito dorsal com elevação de membros inferiores e estimulação elétrica neuromuscular) e controle (posição de decúbito dorsal com elevação de membros inferiores sem a estimulação elétrica neuromuscular). Os pacientes foram alocados no grupo 1 (intervenção e controle) ou grupo 2 (controle e intervenção) com um período de wash-out de 4 a 6 horas. As variáveis metabólicas mensuradas foram o consumo de oxigênio, gasto energético, produção de gás carbônico e quociente respiratório, por intermédio da calorimetria indireta. Já as variáveis fisiológicas foram a pressão arterial média, frequência cardíaca, volume minuto e saturação periférica de oxigênio. Resultados: Dezesseis pacientes foram analisados no estudo do choque séptico agudo e 21 no estudo da sepse e choque séptico na fase tardia. Não houve diferenças significativas entre o os valores do consumo de oxigênio na fase aguda do choque séptico quando os protocolos intervenção e controle foram comparados (186,59 ± 46,10; 183,64 ± 41,39; 188,97 ± 44,88, p>0,05), da mesma forma quando os valores de consumo de oxigênio na fase tardia foram comparados (224,22 ± 53,09; 226,20 ± 49,64; 226,79 ± 58,25, p>0,05). As demais variáveis metabólicas e fisiológicas seguiram o mesmo padrão, sem diferenças significativas entre os protocolos. Quando variáveis da fase aguda foram comparadas com as variáveis da fase tardia, diferenças significativas foram observadas para o consumo de oxigênio, gasto energético, quociente respiratório e pressão arterial média (p0.05), likewise, when the oxygen consumption values in the late phase were compared (224.22 ± 53.09; 226.20 ± 49.64; 226.79 ± 58.25, p>0.05). The other metabolic and physiological variables followed the same pattern, without significant differences between the protocols. When acute phase metabolic variables were compared with late-phase variables, significant differences were observed for oxygen consumption, energy expenditure and respiratory quotient (p<0.05). Conclusions: As there were no alterations in the metabolic and physiological rate during neuromuscular electrical stimulation, either in the first 72 hours after septic shock diagnosis or after, electrical stimulation can be considered a safe intervention in the metabolic and physiological scope, even considering that these patients present a higher metabolic demand during the acute phase of shock

Evaluation of oxygen consumption and resting energy expenditure during spontaneous breathing test

Introdução: O desmame ventilatório é definido como o processo de liberação do suporte ventilatório e como avaliação dessa fase é conduzido o Teste de Respiração Espontânea (TRE). Um dos mais utilizados modos de TRE é a Pressão Positiva Contínua em Vias Aéreas (CPAP), a qual se aplica uma pressão positiva contínua tanto na inspiração quanto na expiração. Contudo, junto com os modos ventilatórios pode ser utilizado a Compensação Automática do Tubo (ATC) cujo objetivo é compensar a resistência imposta pelo tubo endotraqueal. Objetivos: O principal objetivo deste estudo foi comparar o Consumo de Oxigênio (VO2) a o Gasto Energético (GE) pela calorimetria indireta (CI) durante o TRE em CPAP com e sem a ATC. Métodos: O estudo foi randomizado, controlado tipo cross-over com quarenta pacientes em nove leitos de um Centro de Terapia Intensiva de um hospital terciário universitário (Hospital das Clínicas de Ribeirão Preto Universidade de São Paulo, Brasil). Os participantes foram alocados aleatoriamente no grupo 1, no qual era iniciado o TRE em CPAP em uso da ATC e posteriormente em CPAP sem o uso da ATC, ou no grupo 2, no qual era iniciado o TRE em CPAP sem a ATC e em seguida CPAP com a utilização da ATC. Resultados: Cinco pacientes foram excluídos depois da randomização por falha durante o TRE. Dos trinta e cinco restantes a maioria foi do sexo masculino (51%). A média de idade foi de 61,4 ± 16,1 anos. A diferença de VO2 entre os TREs com ATC e sem ATC foi de -1,6 mL.Kg-1.min-1; p=0,23 e intervalo de confiança de 95%: (-4,36; 1,07). Em relação ao GE a diferença foi de -5,4 kcal/d-1; p=0,5 e intervalo de confiança de 95%: (-21,67; 10,79) durante a comparação dos TREs em CPAP com e sem ATC. Conclusão: Não foram observadas diferenças quando se comparou os valores relacionados ao VO2 e GE durante o TRE com e sem ATC.Introduction: Weaning from mechanical ventilation is defined as the process of release of ventilatory support and how the evaluation of this phase is conducted in the spontaneous breathing test (SBT). One of the most used modes of SBT is the Continuous Positive Airway Pressure (CPAP)which applies a continuous positive pressure in both inspiration and expiration. However, together with the mechanical ventilation modes it can be used the Automatic Tube Compensation (ATC) which compensates the resistance imposed by the endotracheal tube. Objectives: The main goal of this study was to compare the Oxygen Consumption (VO2) and Resting Energy Expenditure (REE) by indirect calorimetry (IC) during the SBT in CPAP with and without ATC. Methods: The study was a prospective randomized, controlled crossover trial, that enrolled 40 patients, in a 9-bed Intensive Care Unit of a tertiary University Hospital. (Clinics Hospital of Ribeirão Preto Medical School, University of São Paulo, Brazil). Participants were randomly allocated in Group 1, in which it was started the SBT in CPAP with ATC and later on CPAP without ATC, or in Group 2, which was started the SBT on CPAP without ATC and then CPAP with ATC.Results: Five patients were excluded after randomization for failure of the SBT. The thirty-five remaining patients were most male (51%). The mean age of the sample was 61.4 ± 16.1 years. The difference of VO2 between the SBT with ATC and no ATC obtained a value of -1.6 mL.Kg-1.min-1; p = 0.23 and 95% confidence interval: (-4.36; 1.07). To analyze the difference of REE between the SBT with ATC and no ATC, it was obtained an estimated value of -5.4 kcal/d-1, p = 0.5 and 95% and confidence interval (-21.67; 10.79). Conclusions: There were no differences in the comparison of VO2 and REE during the SBT with and without ATC

Energy expenditure in critically ill surgical patients. Comparative analysis of predictive equation and indirect calorimetry Gasto energético em pacientes cirúrgicos. Análise comparativa entre equação preditiva e calorimetria indireta

PURPOSE: The aim of this investigation was to compare the resting energy expenditure (REE) calculated by the Harris-Benedict equation (REE HB) with the REE measured by indirect calorimetry (REE IC) in critically ill surgical patients under mechanical ventilation. METHODS: Thirty patients were included in this work. REE was calculated by the Harris-Benedict equation (REE HB) using real body weight, and it was also measured by indirect calorimetry (REE IC), which was performed for 30 minutes. RESULTS: REE HB had significant (p < 0.0005) but low correlation (Spearman r = 0.57) with REE IC, with a mean bias of 12 kcal.d-1 and limits of agreement ranging from - 599.7 to 623.7 kcal.d-1 as detected by the Bland-Altman analysis. CONCLUSION: These findings suggest that REE IC seems to be more appropriate than REE HB for accurate measurement of REE in critically ill surgical patients under mechanical ventilation.<br>OBJETIVO: O objetivo deste estudo foi comparar o gasto energético de repouso (GER), calculado pela equação de Harris-Benedict (GER HB) com o GER medido pela calorimetria indireta (GER CI) em pacientes cirúrgicos gravemente enfermos em ventilação mecânica. MÉTODOS: Trinta pacientes foram incluídos nesta investigação. O gasto energético de repouso foi calculado pela equação de Harris-Benedict (GER HB) utilizando o peso corporal real e medido pela calorimetria indireta (GER CI). A calorimetria indireta foi realizada durante 30 minutos. RESULTADOS: O gasto energético de repouso calculado pela equação de Harris-Benedict mostrou uma correlação significativa (p < 0,0005), porém fraca (Spearman r = 0,57) com GER CI, com um viés médio de 12 kcal.d-1 e os limites de concordância variando de - 599,7 a -623,7 kcal.d-1 como detectados pela análise de Bland-Altman. CONCLUSÃO: Estes achados sugerem que a calorimetria indireta parece ser mais apropriada do que a equação de Harris Benedict para a medida exata do GER em pacientes cirúrgicos gravemente enfermos em ventilação mecânica

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