Protocol-directed weaning versus conventional weaning from mechanical ventilation for neurocritical patients in an intensive care unit: a nonrandomized quasi-experimental study.

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.

Protocol-directed weaning versus conventional weaning from mechanical ventilation for neurocritical patients in an intensive care unit: a nonrandomized quasi-experimental study / Desmame da ventilação mecânica por protocolo versus desmame convencional em pacientes neurocríticos de uma unidade de terapia intensiva: um estudo quase experimental não randomizado

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

Pre- and in-hospital anticoagulation therapy in coronavirus disease 2019 patients: a propensity-matched analysis of in-hospital outcomes.

AIMS: To estimate if chronic anticoagulant (CAC) treatment is associated with morbidity and mortality outcomes of patients hospitalized for SARS-CoV-2 infection. METHODS: In this European multicentric cohort study, we included 1186 patients of whom 144 were on CAC (12.1%) with positive coronavirus disease 2019 testing between 1 February and 30 July 2020. The average treatment effect (ATE) analysis with a propensity score-matching (PSM) algorithm was used to estimate the impact of CAC on the primary outcomes defined as in-hospital death, major and minor bleeding events, cardiovascular complications (CCI), and acute kidney injury (AKI). We also investigated if different dosages of in-hospital heparin were associated with in-hospital survival. RESULTS: In unadjusted populations, primary outcomes were significantly higher among CAC patients compared with non-CAC patients: all-cause death (35% vs. 18% P < 0.001), major and minor bleeding (14% vs. 8% P = 0.026; 25% vs. 17% P = 0.014), CCI (27% vs. 14% P < 0.001), and AKI (42% vs. 19% P < 0.001). In ATE analysis with PSM, there was no significant association between CAC and primary outcomes except for an increased incidence of AKI (ATE +10.2%, 95% confidence interval 0.3-20.1%, P = 0.044). Conversely, in-hospital heparin, regardless of dose, was associated with a significantly higher survival compared with no anticoagulation. CONCLUSIONS: The use of CAC was not associated with the primary outcomes except for the increase in AKI. However, in the adjusted survival analysis, any dose of in-hospital anticoagulation was associated with significantly higher survival compared with no anticoagulation.

Ventilación no invasiva versus oxigenoterapia convencional tras fracaso de la extubación en pacientes de alto riesgo en una unidad de cuidados intensivos: un ensayo clínico pragmático / Noninvasive ventilation versus conventional oxygen therapy after extubation failure in high-risk patients in an intensive care unit: a pragmatic clinical trial

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.

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.

Noninvasive ventilation versus conventional oxygen therapy after extubation failure in high-risk patients in an intensive care unit: a pragmatic clinical trial. / Ventilación no invasiva versus oxigenoterapia convencional tras fracaso de la extubación en pacientes de alto riesgo en una unidad de cuidados intensivos: un ensayo clínico pragmático.

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.

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.

Ventilación mecánica no invasiva versus presión continua positiva en la vía aérea en el edema agudo de pulmón cardiogénico en una unidad de cuidados intensivos / Non-Invasive Mechanical Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema in an Intensive Care Unit

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Non-Invasive Mechanical Ventilation Versus Continuous Positive Airway Pressure Relating to Cardiogenic Pulmonary Edema in an Intensive Care Unit / Ventilación mecánica no invasiva frente a presión positiva continua en la vía aérea en el manejo del edema pulmonar cardiogénico en una unidad de cuidados intensivos

Background: To compare the application of non-invasive ventilation (NIV) versus continuous positive airway pressure (CPAP) in the treatment of patients with cardiogenic pulmonary edema (CPE) admitted to an intensive care unit (ICU). Methods: In a prospective, randomized, controlled study performed in an ICU, patients with CPE were assigned to NIV (n=56) or CPAP (n=54). Primary outcome was intubation rate. Secondary outcomes included duration of ventilation, length of ICU and hospital stay, improvement of gas exchange, complications, ICU and hospital mortality, and 28-day mortality. The outcomes were analyzed in hypercapnic patients (PaCO2 > 45 mmHg) with no underlying chronic lung disease. Results: Both devices led to similar clinical and gas exchange improvement; however, in the first 60 min of treatment a higher PaO2/FiO2 ratio was observed in the NIV group (205±112 in NIV vs. 150±84 in CPAP, P=.02). The rate of intubation was similar in both groups (9% in NIV vs. 9% in CPAP, P=1.0). There were no differences in duration of ventilation, ICU and length of hospital stay. There were no significant differences in ICU, hospital and 28-d mortality between groups. In the hypercapnic group, there were no differences between NIV and CPAP. Conclusions: Either NIV or CPAP are recommended in patients with CPE in the ICU. Outcomes in the hypercapnic group with no chronic lung disease were similar using NIV or CPAP

Introducción: Comparar la efectividad de la ventilación no invasiva (VNI) frente a la presión positiva continúa en la vía aérea (CPAP) en pacientes ingresados por edema agudo de pulmón (EAP) cardiogénico en una unidad de cuidados intensivos (UCI). Métodos: Ensayo clínico donde 56 pacientes fueron asignados a VNI y 54 pacientes a CPAP. El objetivo primario fue la tasa de intubación. Los objetivos secundarios fueron: duración de ventilación, estancia en UCI y en el hospital, mejoría gasométrica, complicaciones y mortalidad en UCI, hospitalaria y a los 28 días. Los objetivos fueron analizados en pacientes hipercápnicos (PaCO2 >45mmHg) sin patologia pulmonar. Resultados: Ambos dispositivos obtuvieron similar mejoría clínica y del intercambio gaseoso, sin embargo, la VNI mostró un aumento más rápido de la oxigenación (medido por el cociente PaO2/FiO2) en los primeros 60 minutos de aplicación (205 ± 112 en VNI vs. 150 ± 84 en CPAP, p= 0,02). La tasa de intubación fue similar en ambos grupos (9% en VNI vs. 9% en CPAP, p= 1,0). No hubo diferencias en la duración de la ventilación, ni en la estancia en UCI ni hospitalaria. Tampoco hubo diferencias significativas en la mortalidad en UCI, hospitalaria y a los 28 días entre ambos grupos. En el subgrupo de pacientes hipercápnicos tampoco se observaron diferencias significativas en los objetivos analizados. Conclusiones: La VNI como la CPAP se pueden emplear en pacientes con EAP en la UCI. En pacientes hipercápnicos sin patología pulmonar no se observa beneficio de la VNI sobre la CPAP

Non-Invasive Mechanical Ventilation Versus Continuous Positive Airway Pressure Relating to Cardiogenic Pulmonary Edema in an Intensive Care Unit.

BACKGROUND: To compare the application of non-invasive ventilation (NIV) versus continuous positive airway pressure (CPAP) in the treatment of patients with cardiogenic pulmonary edema (CPE) admitted to an intensive care unit (ICU). METHODS: In a prospective, randomized, controlled study performed in an ICU, patients with CPE were assigned to NIV (n=56) or CPAP (n=54). Primary outcome was intubation rate. Secondary outcomes included duration of ventilation, length of ICU and hospital stay, improvement of gas exchange, complications, ICU and hospital mortality, and 28-day mortality. The outcomes were analyzed in hypercapnic patients (PaCO2>45mmHg) with no underlying chronic lung disease. RESULTS: Both devices led to similar clinical and gas exchange improvement; however, in the first 60min of treatment a higher PaO2/FiO2 ratio was observed in the NIV group (205±112 in NIV vs. 150±84 in CPAP, P=.02). The rate of intubation was similar in both groups (9% in NIV vs. 9% in CPAP, P=1.0). There were no differences in duration of ventilation, ICU and length of hospital stay. There were no significant differences in ICU, hospital and 28-d mortality between groups. In the hypercapnic group, there were no differences between NIV and CPAP. CONCLUSIONS: Either NIV or CPAP are recommended in patients with CPE in the ICU. Outcomes in the hypercapnic group with no chronic lung disease were similar using NIV or CPAP.