Prospective, randomized, controlled trial assessing the effects of a driving pressure-limiting strategy for patients with acute respiratory distress syndrome due to community-acquired pneumonia (STAMINA trial): protocol and statistical analysis plan.

BACKGROUND: Driving pressure has been suggested to be the main driver of ventilator-induced lung injury and mortality in observational studies of acute respiratory distress syndrome. Whether a driving pressure-limiting strategy can improve clinical outcomes is unclear. OBJECTIVE: To describe the protocol and statistical analysis plan that will be used to test whether a driving pressure-limiting strategy including positive end-expiratory pressure titration according to the best respiratory compliance and reduction in tidal volume is superior to a standard strategy involving the use of the ARDSNet low-positive end-expiratory pressure table in terms of increasing the number of ventilator-free days in patients with acute respiratory distress syndrome due to community-acquired pneumonia. METHODS: The ventilator STrAtegy for coMmunIty acquired pNeumoniA (STAMINA) study is a randomized, multicenter, open-label trial that compares a driving pressure-limiting strategy to the ARDSnet low-positive end-expiratory pressure table in patients with moderate-to-severe acute respiratory distress syndrome due to community-acquired pneumonia admitted to intensive care units. We expect to recruit 500 patients from 20 Brazilian and 2 Colombian intensive care units. They will be randomized to a driving pressure-limiting strategy group or to a standard strategy using the ARDSNet low-positive end-expiratory pressure table. In the driving pressure-limiting strategy group, positive end-expiratory pressure will be titrated according to the best respiratory system compliance. OUTCOMES: The primary outcome is the number of ventilator-free days within 28 days. The secondary outcomes are in-hospital and intensive care unit mortality and the need for rescue therapies such as extracorporeal life support, recruitment maneuvers and inhaled nitric oxide. CONCLUSION: STAMINA is designed to provide evidence on whether a driving pressure-limiting strategy is superior to the ARDSNet low-positive end-expiratory pressure table strategy for increasing the number of ventilator-free days within 28 days in patients with moderate-to-severe acute respiratory distress syndrome. Here, we describe the rationale, design and status of the trial.

BENEFITS OF A CLINICAL PATHWAY IN TOTAL KNEE ARTHROPLASTY.

Objective: Demonstrate whether a multiprofessional Clinical Pathway Program in Total Knee Arthroplasty (CPPA) contributesto optimizing hospital care. Method: Retrospective study of medical data of care indicators in 310 patients divided into two groups: A- who underwent arthroplasty in the last biennium before the introduction of the CPPA (n=144) and group B- who underwent TKA in the biennium after the introduction of the CPPA (n=166). Results: Postoperative showed a significant difference in favor of group B over group A for hospitalization time in days 4.33 ± 2.79 and 5.4 ± 1.67 (p<0.001), time of prophylactic antibiotic in hours 28.13 ± 33.77 and 81.49 ± 40.91 (p<0.001), referral to the intensive care unit 40.9% and 73.4% (p<0.001), initiation of thromboprophylaxis within 24 hours 97.9% and 82.5% (p<0.001), use of elastic stockings and/or intermittent compression prescribed for thromboprophylaxis 89.5% and 31.2% (p<0.001), initiation of rehabilitation within 24 hours 90.1% and 66.1% (p<0.001), readmissions within 30 days 4.1% and 3% (p = 0.76), readmissions 90 days 2.7% and 6.6% (p = 0.183), transfusions 5.5% and 15.2% (p = 0.033). Conclusion: The implementation of a multiprofessional CPPA contributed to the implementation of care protocols, favoring greater patient safety. Level of Evidence III; Retrospective Comparative Study.

Objetivo: Demonstrar se um Programa de Cuidados Clínicos multiprofissional em Artroplastia Total de Joelho (PCCA) contribui para a otimização assistencial hospitalar. Método: Estudo retrospectivo em prontuários de indicadores assistenciais em 310 pacientes divididos em dois grupos: A- submetidos a artroplastia no último biênio antecessor a introdução do PCCA (n=144) e grupo B- submetidos a ATJ no biênio após a introdução do PCCA (n=166). Resultados: Indicadores pós-operatórios mostraram diferença significativa a favor do grupo B sobre o grupo A para tempo de hospitalização em dias 4,33 ± 2,79 e 5,4 ± 1,67 (p<0,001), tempo de antibiótico profilático em horas 28,13 ± 33,77 e 81,49 ± 40,91 (p<0,001), encaminhamento para unidade de terapia intensiva 40,9% e 73,4% (p<0,001), início da tromboprofilaxia dentro de 24h 97,9% e 82,5% (p<0,001), uso de meias elásticas e/ou compressão intermitente prescritos para tromboprofilaxia 89,5% e 31,2% (p<0,001), tempo para iniciação da reabilitação em 24h 90,1% e 66,1% (p<0,001), readmissões em 30 dias 4,1% e 3% (p = 0,76), readmissões 90 dias 2,7% e 6,6% (p = 0,183), transfusões 5,5% e 15,2% (p = 0,033). Conclusão: A implementação de um PCCA multiprofissional contribuiu para o cumprimento dos protocolos assistenciais favorecendo maior segurança para os pacientes. Nível de Evidência III; Estudo Retrospectivo Comparativo.

Primary results of the brazilian registry of atherothrombotic disease (NEAT).

There is limited contemporary prospective real-world evidence of patients with chronic arterial disease in Latin America. The Network to control atherothrombosis (NEAT) registry is a national prospective observational study of patients with known coronary (CAD) and/or peripheral arterial disease (PAD) in Brazil. A total of 2,005 patients were enrolled among 25 sites from September 2020 to March 2022. Patient characteristics, medications and laboratorial data were collected. Primary objective was to assess the proportion of patients who, at the initial visit, were in accordance with good medical practices (domains) for reducing cardiovascular risk in atherothrombotic disease. From the total of patients enrolled, 2 were excluded since they did not meet eligibility criteria. Among the 2,003 subjects included in the analysis, 55.6% had isolated CAD, 28.7% exclusive PAD and 15.7% had both diagnoses. Overall mean age was 66.3 (± 10.5) years and 65.7% were male patients. Regarding evidence-based therapies (EBTs), 4% were not using any antithrombotic drug and only 1.5% were using vascular dose of rivaroxaban (2.5 mg bid). Only 0.3% of the patients satisfied all the domains of secondary prevention, including prescription of EBTs and targets of body-mass index, blood pressure, LDL-cholesterol, and adherence of lifestyle recommendations. The main barrier for prescription of EBTs was medical judgement. Our findings highlight that the contemporary practice does not reflect a comprehensive approach for secondary prevention and had very low incorporation of new therapies in Brazil. Large-scale populational interventions addressing these gaps are warranted to improve the use of evidence-based therapies and reduce the burden of atherothrombotic disease.ClinicalTrials.gov NCT04677725.

Benefits of a clinical pathway in total knee arthroplasty / Beneficios de um programa de cuidados clínicos em artroplastia total de joelho

ABSTRACT Objective: Demonstrate whether a multiprofessional Clinical Pathway Program in Total Knee Arthroplasty (CPPA) contributesto optimizing hospital care. Method: Retrospective study of medical data of care indicators in 310 patients divided into two groups: A- who underwent arthroplasty in the last biennium before the introduction of the CPPA (n=144) and group B- who underwent TKA in the biennium after the introduction of the CPPA (n=166). Results: Postoperative showed a significant difference in favor of group B over group A for hospitalization time in days 4.33 ± 2.79 and 5.4 ± 1.67 (p<0.001), time of prophylactic antibiotic in hours 28.13 ± 33.77 and 81.49 ± 40.91 (p<0.001), referral to the intensive care unit 40.9% and 73.4% (p<0.001), initiation of thromboprophylaxis within 24 hours 97.9% and 82.5% (p<0.001), use of elastic stockings and/or intermittent compression prescribed for thromboprophylaxis 89.5% and 31.2% (p<0.001), initiation of rehabilitation within 24 hours 90.1% and 66.1% (p<0.001), readmissions within 30 days 4.1% and 3% (p = 0.76), readmissions 90 days 2.7% and 6.6% (p = 0.183), transfusions 5.5% and 15.2% (p = 0.033). Conclusion: The implementation of a multiprofessional CPPA contributed to the implementation of care protocols, favoring greater patient safety. Level of Evidence III; Retrospective Comparative Study.

RESUMO Objetivo: Demonstrar se um Programa de Cuidados Clínicos multiprofissional em Artroplastia Total de Joelho (PCCA) contribui para a otimização assistencial hospitalar. Método: Estudo retrospectivo em prontuários de indicadores assistenciais em 310 pacientes divididos em dois grupos: A- submetidos a artroplastia no último biênio antecessor a introdução do PCCA (n=144) e grupo B- submetidos a ATJ no biênio após a introdução do PCCA (n=166). Resultados: Indicadores pós-operatórios mostraram diferença significativa a favor do grupo B sobre o grupo A para tempo de hospitalização em dias 4,33 ± 2,79 e 5,4 ± 1,67 (p<0,001), tempo de antibiótico profilático em horas 28,13 ± 33,77 e 81,49 ± 40,91 (p<0,001), encaminhamento para unidade de terapia intensiva 40,9% e 73,4% (p<0,001), início da tromboprofilaxia dentro de 24h 97,9% e 82,5% (p<0,001), uso de meias elásticas e/ou compressão intermitente prescritos para tromboprofilaxia 89,5% e 31,2% (p<0,001), tempo para iniciação da reabilitação em 24h 90,1% e 66,1% (p<0,001), readmissões em 30 dias 4,1% e 3% (p = 0,76), readmissões 90 dias 2,7% e 6,6% (p = 0,183), transfusões 5,5% e 15,2% (p = 0,033). Conclusão: A implementação de um PCCA multiprofissional contribuiu para o cumprimento dos protocolos assistenciais favorecendo maior segurança para os pacientes. Nível de Evidência III; Estudo Retrospectivo Comparativo.

Prospective, randomized, controlled trial assessing the effects of a driving pressure-limiting strategy for patients with acute respiratory distress syndrome due to community-acquired pneumonia (STAMINA trial): protocol and statistical analysis plan / Estudo randomizado prospectivo e controlado de avaliação dos efeitos de uma estratégia de limitação da driving pressure em pacientes com síndrome do desconforto respiratório agudo devido à pneumonia adquirida na comunidade (estudo STAMINA): protocolo e plano de análise estatística

ABSTRACT Background: Driving pressure has been suggested to be the main driver of ventilator-induced lung injury and mortality in observational studies of acute respiratory distress syndrome. Whether a driving pressure-limiting strategy can improve clinical outcomes is unclear. Objective: To describe the protocol and statistical analysis plan that will be used to test whether a driving pressure-limiting strategy including positive end-expiratory pressure titration according to the best respiratory compliance and reduction in tidal volume is superior to a standard strategy involving the use of the ARDSNet low-positive end-expiratory pressure table in terms of increasing the number of ventilator-free days in patients with acute respiratory distress syndrome due to community-acquired pneumonia. Methods: The ventilator STrAtegy for coMmunIty acquired pNeumoniA (STAMINA) study is a randomized, multicenter, open-label trial that compares a driving pressure-limiting strategy to the ARDSnet low-positive end-expiratory pressure table in patients with moderate-to-severe acute respiratory distress syndrome due to community-acquired pneumonia admitted to intensive care units. We expect to recruit 500 patients from 20 Brazilian and 2 Colombian intensive care units. They will be randomized to a driving pressure-limiting strategy group or to a standard strategy using the ARDSNet low-positive end-expiratory pressure table. In the driving pressure-limiting strategy group, positive end-expiratory pressure will be titrated according to the best respiratory system compliance. Outcomes: The primary outcome is the number of ventilator-free days within 28 days. The secondary outcomes are in-hospital and intensive care unit mortality and the need for rescue therapies such as extracorporeal life support, recruitment maneuvers and inhaled nitric oxide. Conclusion: STAMINA is designed to provide evidence on whether a driving pressure-limiting strategy is superior to the ARDSNet low-positive end-expiratory pressure table strategy for increasing the number of ventilator-free days within 28 days in patients with moderate-to-severe acute respiratory distress syndrome. Here, we describe the rationale, design and status of the trial.

RESUMO Contexto: Em estudos observacionais sobre a síndrome do desconforto respiratório agudo, sugeriu-se que a driving pressure é o principal fator de lesão pulmonar induzida por ventilador e de mortalidade. Não está claro se uma estratégia de limitação da driving pressure pode melhorar os desfechos clínicos. Objetivo: Descrever o protocolo e o plano de análise estatística que serão usados para testar se uma estratégia de limitação da driving pressure envolvendo a titulação da pressão positiva expiratória final de acordo com a melhor complacência respiratória e a redução do volume corrente é superior a uma estratégia padrão envolvendo o uso da tabela de pressão positiva expiratória final baixa do protocolo ARDSNet, em termos de aumento do número de dias sem ventilador em pacientes com síndrome do desconforto respiratório agudo devido à pneumonia adquirida na comunidade. Métodos: O estudo STAMINA (ventilator STrAtegy for coMmunIty acquired pNeumoniA) é randomizado, multicêntrico e aberto e compara uma estratégia de limitação da driving pressure com a tabela de pressão positiva expiratória final baixa do protocolo ARDSnet em pacientes com síndrome do desconforto respiratório agudo moderada a grave devido à pneumonia adquirida na comunidade internados em unidades de terapia intensiva. Esperamos recrutar 500 pacientes de 20 unidades de terapia intensiva brasileiras e duas colombianas. Eles serão randomizados para um grupo da estratégia de limitação da driving pressure ou para um grupo de estratégia padrão usando a tabela de pressão positiva expiratória final baixa do protocolo ARDSnet. No grupo da estratégia de limitação da driving pressure, a pressão positiva expiratória final será titulada de acordo com a melhor complacência do sistema respiratório. Desfechos: O desfecho primário é o número de dias sem ventilador em 28 dias. Os desfechos secundários são a mortalidade hospitalar e na unidade de terapia intensiva e a necessidade de terapias de resgate, como suporte de vida extracorpóreo, manobras de recrutamento e óxido nítrico inalado. Conclusão: O STAMINA foi projetado para fornecer evidências sobre se uma estratégia de limitação da driving pressure é superior à estratégia da tabela de pressão positiva expiratória final baixa do protocolo ARDSnet para aumentar o número de dias sem ventilador em 28 dias em pacientes com síndrome do desconforto respiratório agudo moderada a grave. Aqui, descrevemos a justificativa, o desenho e o status do estudo.

Comparação dos marcadores de alteração na deglutição entre pacientes com e sem Covid-19 pós-intubação orotraqueal / Comparison of swallowing alteration markers between patients with and without Covid-19 post-orotracheal intubation

RESUMO Objetivo comparar os marcadores de alteração na deglutição de pacientes com e sem COVID-19 e estudar as variáveis preditivas de contraindicação da alimentação por via oral em pacientes com necessidade de intubação orotraqueal prolongada. Métodos estudo caso-controle, retrospectivo, com coleta de prontuário de variáveis clínicas e demográficas e da avaliação clínica da deglutição. As variáveis coletadas foram comparadas estatisticamente entre pacientes com COVID-19 (grupo estudo -GE) e sem COVID-19 (grupo-controle - GC). A análise de regressão de robusta de Poisson foi utilizada para avaliar o efeito da COVID-19 e das demais variáveis na contraindicação da alimentação por via oral. Resultados foram incluídos 351 pacientes, 269 no GE e 82 no GC. Pacientes do GE apresentaram menor idade, quando comparados ao GC (50,7 ± 12,8). O tempo total de intubação orotraqueal foi significativamente maior no GE. Os pacientes do GE apresentaram maior prevalência de tosse fraca, disfonia, piores graus de disfagia e maior ocorrência de contraindicação da alimentação por via oral. Na análise bivariada, verificou-se que os pacientes com COVID-19 apresentaram 65% maior probabilidade dessa contraindicação. Entretanto, quando a COVID-19 foi ajustada com outras variáveis clínicas e demográficas, verificou-se que as estas apresentaram maior influência sobre a contraindicação de alimentação por via oral do que a COVID-19. Conclusão a intubação orotraqueal prolongada teve pior efeito nos marcadores de alteração na deglutição e na reintrodução da via oral de pacientes com COVID-19. A idade maior que 60 anos, tempo de intubação orotraqueal maior que cinco dias, reintubação e delirium demonstraram ser preditivas de contraindicação da alimentação por via oral em pacientes intubados.

ABSTRACT Purpose To compare the swallowing alteration markers in patients with and without COVID-19 and to study the predictive variables of oral feeding contraindication in patients requiring prolonged orotracheal intubation. Methods Retrospective case-control study, with medical record data collection of clinical and demographic variables and the clinical evaluation of swallowing. The collected variables were statistically compared between patients with COVID-19 (SG) and without COVID-19 (CG). Robust Poisson regression analysis was used to evaluate the effect of COVID-19 and other variables on oral feeding contraindication. Results 351 patients were included, 269 in the SG and 82 in the CG. Patients in the SG were younger when compared to the CG (50.7 ± 12.8). The total time of orotracheal intubation was significantly longer in the SG. The patients in the SG had a higher prevalence of weak cough, dysphonia, worse degrees of dysphagia and higher occurrence of contraindication of oral feeding. In the bivariate analysis, it was found that patients with COVID-19 were 65% more likely to have oral feeding contraindication. However, when COVID-19 was adjusted with other clinical and demographic variables, it was found that these variables had a greater influence on the contraindication of the oral feeding than the COVID-19. Conclusion Prolonged orotracheal intubation had a worse effect on alteration markers in swallowing and reintroduction of the oral feeding in COVID-19 patients. Age over 60 years, orotracheal intubation time greater than 5 days, reintubation, and delirium were shown to be predictive of oral feeding contraindication in intubated patients.