ABSTRACT Objective: To investigate whether protocol-directed weaning in neurocritical patients would reduce the rate of extubation failure (as a primary outcome) and the associated complications (as a secondary outcome) compared with conventional weaning. Methods: A quasi-experimental study was conducted in a medical-surgical intensive care unit from January 2016 to December 2018. Patients aged 18 years or older with an acute neurological disease who were on mechanical ventilation > 24 hours were included. All patients included in the study were ready to wean, with no or minimal sedation, Glasgow coma score ≥ 9, spontaneous ventilatory stimulus, noradrenaline ≤ 0.2μgr/kg/ minute, fraction of inspired oxygen ≤ 0.5, positive end-expiratory pressure ≤ 5cmH2O, maximal inspiratory pressure < -20cmH2O, and occlusion pressure < 6cmH2O. Results: Ninety-four of 314 patients admitted to the intensive care unit were included (50 in the Intervention Group and 44 in the Control Group). There was no significant difference in spontaneous breathing trial failure (18% in the Intervention Group versus 34% in the Control Group, p = 0.12). More patients in the Intervention Group were extubated than in the Control Group (100% versus 79%, p = 0.01). The rate of extubation failure was not signifiantly diffrent between the groups (18% in the Intervention Group versus 17% in the Control Group; relative risk 1.02; 95%CI 0.64 - 1.61; p = 1.00). The reintubation rate was lower in the Control Group (16% in the Intervention Group versus 11% in the Control Group; relative risk 1.15; 95%CI 0.74 - 1.82; p = 0.75). The need for tracheotomy was lower in the Intervention Group [4 (8%) versus 11 (25%) in the Control Group; relative risk 0.32; 95%CI 0.11 - 0.93; p = 0.04]. At Day 28, the patients in the Intervention Group had more ventilator-free days than those in the Control Group [28 (26 - 28) days versus 26 (19 - 28) days; p = 0.01]. The total duration of mechanical ventilation was shorter in the Intervention Group than in the Control Group [5 (2 - 13) days versus 9 (3 - 22) days; p = 0.01]. There were no diffrences in the length of intensive care unit stay, 28-day free from mechanical ventilation, hospital stay or 90-day mortality. Conclusion: Considering the limitations of our study, the application of a weaning protocol for neurocritical patients led to a high percentage of extubation, a reduced need for tracheotomy and a shortened duration of mechanical ventilation. However, there was no reduction in extubation failure or the 28-day free of from mechanical ventilation compared with the Control Group. ClinicalTrials.gov Registry:NCT03128086

RESUMO Objetivo: Investigar se o desmame por protocolo em pacientes neurocríticos reduz a taxa de falha de extubação (desfecho primário) e as complicações associadas (desfecho secundário) em comparação com o desmame convencional. Métodos: Realizou-se um estudo quase experimental em uma unidade de terapia intensiva médico-cirúrgica de janeiro de 2016 a dezembro de 2018. Foram incluídos pacientes com 18 anos de idade ou mais, com doença neurológica aguda e em ventilação mecânica > 24 horas. Todos os pacientes incluídos no estudo estavam prontos para o desmame, com nenhuma ou mínima sedação, escala de coma de Glasgow ≥ 9, estímulo ventilatório espontâneo, noradrenalina ≤ 0,2μgr/kg/minuto, fração inspirada de oxigênio ≤ 0,5, pressão expiratória positiva final ≤ 5cmH2O, pressão inspiratória máxima < -20cmH2O e pressão de oclusão < 6cmH2O. Resultados: Foram incluídos 94 dos 314 pacientes admitidos à unidade de terapia intensiva, sendo 50 no Grupo Intervenção e 44 no Grupo Controle. Não houve diferença significativa na falha do ensaio respiratório espontâneo (18% no Grupo Intervenção versus 34% no Grupo Controle, p = 0,12). Foram extubados mais pacientes no Grupo Intervenção do que no Controle (100% versus 79%; p = 0,01). A taxa de falha de extubação não foi significativamente diferente entre os grupos (18% no Grupo Intervenção versus 17% no Grupo Controle, risco relativo de 1,02; IC95% 0,64 - 1,61; p = 1,00). A taxa de reintubação foi menor no Grupo Controle (16% no Grupo Intervenção versus 11% no Grupo Controle; risco relativo de 1,15; IC95% 0,74 -1,82; p = 0,75). A necessidade de traqueotomia foi menor no Grupo Intervenção [4 (8%) versus 11 (25%) no Grupo Controle; risco relativo de 0,32; IC95% 0,11 - 0,93; p = 0,04]. Aos 28 dias, os pacientes do Grupo Intervenção tinham mais dias sem ventilador do que os do Grupo Controle [28 (26 - 28) dias versus 26 (19 - 28) dias; p = 0,01]. A duração total da ventilação mecânica foi menor no Grupo Intervenção do que no Controle [5 (2 - 13) dias versus 9 (3 - 22) dias; p = 0,01]. Não houve diferenças no tempo de internação na unidade de terapia intensiva, 28 dias sem ventilação mecânica, internação hospitalar ou mortalidade em 90 dias. Conclusão: Considerando as limitações de nosso estudo, a aplicação de um protocolo de desmame em pacientes neurocríticos levou à maior proporção de extubação, à menor necessidade de traqueotomia e à menor duração da ventilação mecânica. Entretanto, não houve redução na falha de extubação ou 28 dias sem ventilação mecânica em comparação com o Grupo de Controle. Registro ClinicalTrials.gov:NCT03128086

ABSTRACT Objective: To determine the effectiveness of noninvasive ventilation versus conventional oxygen therapy in patients with acute respiratory failure after extubation failure. Methods: A pragmatic clinical trial was conducted in an intensive care unit from March 2009 to September 2016. Patients on mechanical ventilation > 24 hours who developed acute respiratory failure after scheduled extubation were included and were assigned to noninvasive ventilation or conventional oxygen therapy. The primary objective was to reduce the reintubation rate. The secondary objectives were to improve respiratory parameters and reduce complications, the duration of mechanical ventilation, the intensive care unit stay, the hospital stay, and mortality in the intensive care unit, in the hospital, and 90 days after discharge. Factors correlated with reintubation were also analyzed. Results: Of a total of 2,574 patients, 77 were analyzed (38 in the noninvasive ventilation group and 39 in the conventional oxygen therapy group). Noninvasive ventilation reduced the respiratory and cardiac rates more rapidly than conventional oxygen therapy. Reintubation was less common in the noninvasive ventilation group [12 (32%) versus 22 (56%) in the conventional oxygen therapy group, relative risk 0.58 (95%CI 0.34 - 0.97), p = 0.039]. The rest of the parameters did not show significant differences. In the multivariate analysis, noninvasive ventilation protected against reintubation [OR 0.17 (95%CI 0.05 - 0.56), p = 0.004], while liver failure before extubation and the inability to maintain airway patency predisposed patients to reintubation. Conclusion: The use of noninvasive ventilation in patients who failed extubation could be beneficial compared to conventional oxygen therapy.

RESUMEN Objetivo: Determinar la efectividad de la ventilación no invasiva frente a oxigenoterapia convencional en pacientes con insuficiencia respiratoria aguda tras fracaso de la extubación. Métodos: Ensayo clínico pragmático realizado una unidad de cuidados intensivos de marzo de 2009 a septiembre de 2016. Se incluyeron pacientes sometidos a ventilación mecánica > 24 horas, y que desarrollaron insuficiencia respiratoria aguda tras extubación programada, siendo asignados a ventilación no invasiva u oxigenoterapia convencional. El objetivo primario fue reducir la tasa de reintubación. Los objetivos secundarios fueron: mejora de los parámetros respiratorios, reducción de las complicaciones, de la duración de la ventilación mecánica, de la estancia en unidad de cuidados intensivos y hospitalaria, así como de la mortalidad en unidad de cuidados intensivos, hospitalaria y a los 90 días. También se analizaron los factores relacionados con la reintubación. Resultados: De un total de 2.574 pacientes, se analizaron 77 (38 en el grupo de ventilación no invasiva y 39 en el grupo de oxigenoterapia convencional). La ventilación no invasiva redujo la frecuencia respiratoria y cardíaca más rápidamente que la oxigenoterapia convencional. La reintubación fue menor en el grupo de ventilación no invasiva [12 (32%) versus 22(56%) en grupo oxigenoterapia convencional, RR 0,58 (IC95% 0,34 - 0,97), p = 0,039], el resto de los parámetros no mostró diferencias significativas. En el análisis multivariante, la ventilación no invasiva prevenía la reintubación [OR 0,17 (IC95% 0,05 - 0,56), p = 0,004], mientras que el fracaso hepático previo a la extubación y la incapacidad para mantener vía aérea permeable predisponían a la reintubación. Conclusión: El empleo de la ventilación no invasiva en pacientes que fracasa la extubación podría ser beneficiosa frente a la oxigenoterapia convencional.