Comparação entre testes de ventilação espontânea através de pressão de suporte ou tubo-T na descontinuação da ventilação mecânica em pacientes portadores de doença pulmonar obstrutiva crônica : um ensaio clínico randomizado

Fundamentação: A melhor estratégia para descontinuação da VM em pacientes portadores de DPOC não está estabelecida. Os Testes de Ventilação Espontânea (TVEs) são parte essencial deste processo. Objetivo: Comparar os TVEs em Tubo “T” com PSV em pacientes portadores de DPOC. Métodos: Realizou-se extensa revisão da literatura, além de duas revisões sistemáticas com metanálise acerca do tema, e um ensaio clínico incluindo portadores de DPOC randomizados para TVE de 30 minutos em Tubo “T” ou PSV de 10cmH2O. Os desfechos primários do experimento foram o tempo total de VM e o tempo de VM após o TVE. Resultados: A literatura acerca do tema é vasta entretanto ainda inconsistente; os TVEs podem apresentar desempenho diferente de acordo com o perfil do paciente. Quanto ao ensaio clínico, 190 pacientes foram randomizados para TVE em Tubo-T (n = 99) ou TVE em PSV (n = 91). Houve 29,5% de falha de extubação em 48h no grupo Tubo-T e 24,2% no grupo PSV (p = 0,508). O tempo médio total de VM foi de 10,82 ± 9,1 dias para Tubo-T e 7,31 ± 4,9 para PSV (p < 0,001); entretanto, o tempo pré-TVE também diferiu entre os grupos (7,35 ± 3,9 e 5,84 ± 3,3 respectivamente [p = 0,002]). O tempo pós-TVE foi de 8,36 ± 11,04 dias para Tubo-T e 4,06 ± 4,94 dias para o grupo PSV (Razão de Médias = 2.06 [1.29 - 3.27]; p = 0,002), para os pacientes em desmame difícil. O TVE em Tubo-T foi independentemente associado com o tempo pós-TVE neste subgrupo, mesmo quando ajustado para potenciais confundidores. Conclusão: Para pacientes portadores de DPOC em desmame difícil, o TVE em Tubo-T foi independentemente associado com um maior tempo de VM após o TVE

Study protocol to assess the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units : a cluster-randomised, crossover trial (The ICU Visits Study)

Introduction Flexible intensive care unit (ICU) visiting hours have been proposed as a means to improve patient-centred and family-centred care. However, randomised trials evaluating the effects of flexible family visitation models (FFVMs) are scarce. This study aims to compare the effectiveness and safety of an FFVM versus a restrictive family visitation model (RFVM) on delirium prevention among ICU patients, as well as to analyse its potential effects on family members and ICU professionals. Methods and analysis A cluster-randomised crossover trial involving adult ICU patients, family members and ICU professionals will be conducted. Forty medical-surgical Brazilian ICUs with RFVMs (<4.5 hours/day) will be randomly assigned to either an RFVM (visits according to local policies) or an FFVM (visitation during 12 consecutive hours per day) group at a 1:1 ratio. After enrolment and follow-up of 25 patients, each ICU will be switched over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome will be the cumulative incidence of delirium among ICU patients, measured twice a day using the Confusion Assessment Method for the ICU. Secondary outcome measures will include daily hazard of delirium, ventilator-free days, any ICU-acquired infections, ICU length of stay and hospital mortality among the patients; symptoms of anxiety and depression and satisfaction among the family members; and prevalence of burnout symptoms among the ICU professionals. Tertiary outcomes will include need for antipsychotic agents and/or mechanical restraints, coma-free days, unplanned loss of invasive devices and ICU-acquired pneumonia, urinary tract infection or bloodstream infection among the patients; self-perception of involvement in patient care among the family members; and satisfaction among the ICU professionals

Statistical analysis plan for a clusterrandomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU Visits Study)

Background Most adult intensive care units (ICUs) worldwide adopt restrictive family visitation models (RFVMs). However, evidence, mostly from non-randomized studies, suggests that flexible adult ICU visiting hours are safe policies that can result in benefits such as prevention of delirium and increase in satisfaction with care. Accordingly, the ICU Visits Study was designed to compare the effectiveness and safety of a flexible family visitation model (FFVM) vs. an RFVM on delirium prevention among ICU patients, and also to analyze its potential effects on family members and ICU professionals. Methods/design The ICU Visits Study is a cluster-randomized crossover trial which compares an FFVM (12 consecutive ICU visiting hours per day) with an RFVM (< 4.5 ICU visiting hours per day) in 40 Brazilian adult ICUs. Participant ICUs are randomly assigned to either an FFVM or RFVM in a 1:1 ratio. After enrollment and follow-up of 25 patients, each ICU is crossed over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome is the cumulative incidence of delirium measured by the Confusion Assessment Method for the ICU. Secondary and tertiary outcomes include relevant measures of effectiveness and safety of ICU visiting policies among patients, family members, and ICU professionals. Herein, we describe all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of this study. This pre-specified statistical analysis plan was written and submitted without knowledge of the study data. Discussion This a priori statistical analysis plan aims to enhance the transparency of our study, facilitating unbiased analyses of ICU visit study data, and provide guidance for statistical analysis for groups conducting studies in the same field

Association between prolonged corticosteroids use in COVID-19 and increased mortality in hospitalized patients : a retrospective study with inverse probability of treatment weighting analysis

Background: Previous studies have demonstrated a beneficial effect of early use of corticosteroids in patients with COVID-19. This study aimed to compare hospitalized patients with COVID-19 who received short-course corticosteroid treatment with those who received prolonged-course corticosteroid treatment to determine whether prolonged use of corticosteroids improves clinical outcomes, including mortality. Methods: This is a retrospective cohort study including adult patients with positive testing for Sars-CoV-2 hospitalized for more than 10 days. Data were obtained from electronic medical records. Patients were divided into two groups, according to the duration of treatment with corticosteroids: a short-course (10 days) and a prolonged-course (longer than 10 days) group. Inverse probability treatment weighting (IPTW) analysis was used to evaluate whether prolonged use of corticosteroids improved outcomes. The primary outcome was in-hospital mortality. Secondary outcomes were hospital infection and the association of different doses of corticosteroids with hospital mortality. Restricted cubic splines were used to assess the nonlinear association between mortality and dose and duration of corticosteroids use. Results: We enrolled 1,539 patients with COVID-19. Among them, 1127 received corticosteroids for more than 10 days (prolonged-course group). The in-hospital mortality was higher in patients that received prolonged course corticosteroids (39.5% vs. 26%, p < 0.001). The IPTW revealed that prolonged use of corticosteroids significantly increased mortality [relative risk (RR) = 1.52, 95% confidence interval (95% CI): 1.24-1.89]. In comparison to short course treatment, the cubic spline analysis showed an inverted U-shaped curve for mortality, with the highest risk associated with the prolonged use at 30 days (RR = 1.50, 95% CI 1.21-1.78). Conclusions: Prolonged course of treatment with corticosteroids in hospitalized patients with COVID-19 was associated with higher mortality

Pressure-support ventilation or T-piece spontaneous breathing trials for patients with chronic obstructive pulmonary disease : a randomized controlled trial

Background Little is known about the best strategy for weaning patients with chronic obstructive pulmonary disease (COPD) from mechanical ventilation. Spontaneous breathing trials (SBT) using a T-piece or pressure-support ventilation (PSV) have a central role in this process. Our aim was to compare T-piece and PSV SBTs according to the duration of mechanical ventilation (MV) in patients with COPD. Methods Patients with COPD who had at least 48 hours of invasive MV support were randomized to 30 minutes of T-piece or PSV at 10 cm H2O after being considered able to undergo a SBT. All patients were preemptively connected to non-invasive ventilation after extubation. Tracheostomized patients were excluded. The primary outcome was total invasive MV duration. Time to liberation from MV was assessed as secondary outcome. Results Between 2012 and 2016, 190 patients were randomized to T-piece (99) or PSV (91) groups. Extubation at first SBT was achieved in 78% of patients. The mean total MV duration was 10.82 ± 9.1 days for the T-piece group and 7.31 ± 4.9 days for the PSV group (p < 0.001); however, the pre-SBT duration also differed (7.35 ± 3.9 and 5.84 ± 3.3, respectively; p = 0.002). The time to liberation was 8.36 ± 11.04 days for the T-piece group and 4.06 ± 4.94 for the PSV group (univariate mean ratio = 2.06 [1.29±3.27], p = 0.003) for the subgroup of patients with difficult or prolonged weaning. The study group was independently associated with the time to liberation in this subgroup.Conclusions The SBT technique did not influence MV duration for patients with COPD. For the difficult/ prolonged weaning subgroup, the T-piece may be associated with a longer time to liberation, although this should be clarified by further studies

Grau de conhecimento e controle e hipertensão arterial de uma coorte ambulatorial de cardiopatas isquêmicos

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