Aplicación de la ventilación mecánica no invasiva en pacientes hipoxémicos. Estudio prospectivo randomizado

Pese al beneficio de la ventilación mecánica no invasiva (VMNI) en pacientes con insuficiencia respiratoria (IRA), no se ha establecido una clara indicación en hipoxemia. Con esta premisa, se planteó como hipótesis de trabajo si la VMNI puede ser una alternativa a la VMI en IRA hipoxémica. OBJETIVOS: Objetivo primario reducción de la mortalidad en comparación con la VMI. Objetivos secundarios: aquellos derivados de un menor porcentaje de intubación: mejoría de la oxigenación, disminución de días de ventilación mecánica, menor estancia en UCI y hospitalaria, menor tasa complicaciones. METODOLOGÍA: Se incluyeron pacientes médico/quirúrgicos ingresados en UCI, con IRA hipoxémica según los criterios: 1) disnea en reposo y frecuencia respiratoria>35rpm; 2) paO280. Si persistía la IRA a pesar de la oxigenoterapia, los pacientes fueron asignados al grupo a estudio (VMNI) o grupo control (VMI), previa aleatorización mediante método simple. Se recogieron variables demográficas, hemodinámicas y respiratorias al ingreso y durante el proceso ventilatorio. El estudio fue aprobado por el Comité de Bioética Asistencial y se solicitó consentimiento informado. Se estimó un tamaño muestral de 94 casos con nivel de confianza del 95% (p=0,05) y una potencia del 80%, que mostraba una mortalidad en el grupo VMNI del 20% frente al 47% grupo control. Se empleó el método de T-Student o U-Mann Whitney para las variables cuantitativas, según muestras paramétricas o no paramétricas. Para las variables cualitativas se utilizó la prueba del Chi cuadrado. Significación estadística si p<0,05. Se determinó la supervivencia acumulada por el método de Kaplan-Meier y el test log-rank para la significación entre ambos grupos a los 90 días de la randomización. Para determinar los factores relacionados con la supervivencia se realizó análisis univariante y multivariante mediante regresión logística binaria, odds ratio (OR) con su intervalo de confianza al 95% (IC 95. La capacidad discriminativa del modelo predictivo de supervivencia se estimó mediante la curva de características operativas del receptor (ROC) y la bondad del ajuste del modelo a través de la prueba de Hosmer-Lemeshow RESULTADOS: Entre junio de 2001 hasta julio de 2006 se incluyeron un total de 64 pacientes de una muestra de 230 pacientes que cumplían criterios de inclusión. Tras una exclusión en un segundo paso, finalmente se analizaron 49 pacientes (25 casos que recibieron VMNI y 24 que recibieron VMI). La mortalidad fue semejante en ambos grupos (36% VMNI vs 33% en VMI, p=1,0), pero con una menor tasa de complicaciones en el grupo de VMNI (sobre todo fracaso renal agudo, fracaso multiorgánico, infección nosocomial), una mayor estabilidad hemodinámica, menor duración de la ventilación mecánica y de estancia en UCI en el grupo no invasivo. El porcentaje de intubación se situó en un 52%. En el análisis de subgrupos, el grupo de VMNI que fracasó presentó una mayor mortalidad con respecto al control. Dentro del grupo a estudio, los pacientes que requirieron intubación mostraron como única diferencia con respecto al grupo de éxito, un menor índice cardiaco en situación basal. Durante la evolución, este parámetro se mantuvo, a la vez que estos pacientes presentaron mayor acidosis metabólica. En el análisis multivariante, la presencia de acidosis metabólica (OR 24 [IC95%, 1,39 - 419,3] p=0,02) se identificó como factor predictivo de mortalidad con una capacidad discriminativa mediante la curva ROC del 91% (IC95%, 0,85 – 1,03) y una calibración mediante el test de Hosmer-Lemeshow que no resultó significativa. CONCLUSIONES La VMNI podría estar justificada como tratamiento del paciente hipoxémico, en base a que según nuestros resultados presentó similar mortalidad y mejoría de la oxigenación, pero con menor tasa de complicaciones que el grupo VMI.Background: Non-invasive positive pressure ventilation (NPPV) has shown a reduction in both intubation and mortality rates in hypoxemic acute respiratory failure (ARF) patients. However there is no a firm indication of its use. Methods: Forty-nine ARF hypoxemic patients were randomized to assess the NPPV versus invasive mechanical ventilation (MV). The primary outcome was defined as a reduction of mortality rate in NPPV group. Secondary outcomes were a lower intubation rate, an improvement of oxygenation, shorter length of mechanical ventilation, ICU and hospital stay, and lower complications rate in the NPPV group. Results: Mortality rate was similar in both groups (36% NPPV versus 33% MV, p=1.0), but it was higher in the failure NPPV group (69% versus 33%, p=0.03). Intubation was required in 13 (52%) patients. The NPPV group showed shorter duration of ventilation (5 versus 14 days, p=0.02), shorter ICU (8 versus 20 days, p=0.003) and hospital stay (25 versus 31 days, p=0.32) than MV group. The NPPV group also had fewer complications. Univariate analysis for mortality in the NPPV group was related to the existence of metabolic acidosis (p=0.006), events of cardio respiratory arrest (p=0.006), and NPPV failure (p=0.001). Multivariate analysis in the NPPV group showed the increased of metabolic acidosis as a mortality predictive factor [OR 24.1 (CI 95% 1,39 – 419,3); p=0.02] with a 91% (IC95%, 0,85 - 1,03) ROC curve. Conclusions: NPPV might be justified as a treatment in hypoxemic patients with similar mortality rate and a close oxygenation improvement compared to MV group, but with lower complication rate

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

El presente estudio ha sido presentado en el XLIII Congreso de la Sociedad Española de Medicina Intensiva en Granada, junio de 2018.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 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 >45 mmHg) 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

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 &lt; 0.001), major and minor bleeding (14% vs. 8% P = 0.026; 25% vs. 17% P = 0.014), CCI (27% vs. 14% P &lt; 0.001), and AKI (42% vs. 19% P &lt; 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

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\u200a&lt;\u200a0.001), major and minor bleeding (14% vs. 8% P\u200a=\u200a0.026; 25% vs. 17% P\u200a=\u200a0.014), CCI (27% vs. 14% P\u200a&lt;\u200a0.001), and AKI (42% vs. 19% P\u200a&lt;\u200a0.001). 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\u200a=\u200a0.044). 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

Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study

Background Current management practices and outcomes in weaning from invasive mechanical ventilation are poorly understood. We aimed to describe the epidemiology, management, timings, risk for failure, and outcomes of weaning in patients requiring at least 2 days of invasive mechanical ventilation. Methods WEAN SAFE was an international, multicentre, prospective, observational cohort study done in 481 intensive care units in 50 countries. Eligible participants were older than 16 years, admitted to a participating intensive care unit, and receiving mechanical ventilation for 2 calendar days or longer. We defined weaning initiation as the first attempt to separate a patient from the ventilator, successful weaning as no reintubation or death within 7 days of extubation, and weaning eligibility criteria based on positive end-expiratory pressure, fractional concentration of oxygen in inspired air, and vasopressors. The primary outcome was the proportion of patients successfully weaned at 90 days. Key secondary outcomes included weaning duration, timing of weaning events, factors associated with weaning delay and weaning failure, and hospital outcomes. This study is registered with ClinicalTrials.gov, NCT03255109. Findings Between Oct 4, 2017, and June 25, 2018, 10 232 patients were screened for eligibility, of whom 5869 were enrolled. 4523 (77·1%) patients underwent at least one separation attempt and 3817 (65·0%) patients were successfully weaned from ventilation at day 90. 237 (4·0%) patients were transferred before any separation attempt, 153 (2·6%) were transferred after at least one separation attempt and not successfully weaned, and 1662 (28·3%) died while invasively ventilated. The median time from fulfilling weaning eligibility criteria to first separation attempt was 1 day (IQR 0–4), and 1013 (22·4%) patients had a delay in initiating first separation of 5 or more days. Of the 4523 (77·1%) patients with separation attempts, 2927 (64·7%) had a short wean (≤1 day), 457 (10·1%) had intermediate weaning (2–6 days), 433 (9·6%) required prolonged weaning (≥7 days), and 706 (15·6%) had weaning failure. Higher sedation scores were independently associated with delayed initiation of weaning. Delayed initiation of weaning and higher sedation scores were independently associated with weaning failure. 1742 (31·8%) of 5479 patients died in the intensive care unit and 2095 (38·3%) of 5465 patients died in hospital. Interpretation In critically ill patients receiving at least 2 days of invasive mechanical ventilation, only 65% were weaned at 90 days. A better understanding of factors that delay the weaning process, such as delays in weaning initiation or excessive sedation levels, might improve weaning success rates

Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study

Background: Current management practices and outcomes in weaning from invasive mechanical ventilation are poorly understood. We aimed to describe the epidemiology, management, timings, risk for failure, and outcomes of weaning in patients requiring at least 2 days of invasive mechanical ventilation. Methods: WEAN SAFE was an international, multicentre, prospective, observational cohort study done in 481 intensive care units in 50 countries. Eligible participants were older than 16 years, admitted to a participating intensive care unit, and receiving mechanical ventilation for 2 calendar days or longer. We defined weaning initiation as the first attempt to separate a patient from the ventilator, successful weaning as no reintubation or death within 7 days of extubation, and weaning eligibility criteria based on positive end-expiratory pressure, fractional concentration of oxygen in inspired air, and vasopressors. The primary outcome was the proportion of patients successfully weaned at 90 days. Key secondary outcomes included weaning duration, timing of weaning events, factors associated with weaning delay and weaning failure, and hospital outcomes. This study is registered with ClinicalTrials.gov, NCT03255109. Findings: Between Oct 4, 2017, and June 25, 2018, 10 232 patients were screened for eligibility, of whom 5869 were enrolled. 4523 (77·1%) patients underwent at least one separation attempt and 3817 (65·0%) patients were successfully weaned from ventilation at day 90. 237 (4·0%) patients were transferred before any separation attempt, 153 (2·6%) were transferred after at least one separation attempt and not successfully weaned, and 1662 (28·3%) died while invasively ventilated. The median time from fulfilling weaning eligibility criteria to first separation attempt was 1 day (IQR 0-4), and 1013 (22·4%) patients had a delay in initiating first separation of 5 or more days. Of the 4523 (77·1%) patients with separation attempts, 2927 (64·7%) had a short wean (≤1 day), 457 (10·1%) had intermediate weaning (2-6 days), 433 (9·6%) required prolonged weaning (≥7 days), and 706 (15·6%) had weaning failure. Higher sedation scores were independently associated with delayed initiation of weaning. Delayed initiation of weaning and higher sedation scores were independently associated with weaning failure. 1742 (31·8%) of 5479 patients died in the intensive care unit and 2095 (38·3%) of 5465 patients died in hospital. Interpretation: In critically ill patients receiving at least 2 days of invasive mechanical ventilation, only 65% were weaned at 90 days. A better understanding of factors that delay the weaning process, such as delays in weaning initiation or excessive sedation levels, might improve weaning success rates. Funding: European Society of Intensive Care Medicine, European Respiratory Society

Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study

International audienceBackground: Current management practices and outcomes in weaning from invasive mechanical ventilation are poorly understood. We aimed to describe the epidemiology, management, timings, risk for failure, and outcomes of weaning in patients requiring at least 2 days of invasive mechanical ventilation. Methods: WEAN SAFE was an international, multicentre, prospective, observational cohort study done in 481 intensive care units in 50 countries. Eligible participants were older than 16 years, admitted to a participating intensive care unit, and receiving mechanical ventilation for 2 calendar days or longer. We defined weaning initiation as the first attempt to separate a patient from the ventilator, successful weaning as no reintubation or death within 7 days of extubation, and weaning eligibility criteria based on positive end-expiratory pressure, fractional concentration of oxygen in inspired air, and vasopressors. The primary outcome was the proportion of patients successfully weaned at 90 days. Key secondary outcomes included weaning duration, timing of weaning events, factors associated with weaning delay and weaning failure, and hospital outcomes. This study is registered with ClinicalTrials.gov, NCT03255109. Findings: Between Oct 4, 2017, and June 25, 2018, 10 232 patients were screened for eligibility, of whom 5869 were enrolled. 4523 (77·1%) patients underwent at least one separation attempt and 3817 (65·0%) patients were successfully weaned from ventilation at day 90. 237 (4·0%) patients were transferred before any separation attempt, 153 (2·6%) were transferred after at least one separation attempt and not successfully weaned, and 1662 (28·3%) died while invasively ventilated. The median time from fulfilling weaning eligibility criteria to first separation attempt was 1 day (IQR 0–4), and 1013 (22·4%) patients had a delay in initiating first separation of 5 or more days. Of the 4523 (77·1%) patients with separation attempts, 2927 (64·7%) had a short wean (≤1 day), 457 (10·1%) had intermediate weaning (2–6 days), 433 (9·6%) required prolonged weaning (≥7 days), and 706 (15·6%) had weaning failure. Higher sedation scores were independently associated with delayed initiation of weaning. Delayed initiation of weaning and higher sedation scores were independently associated with weaning failure. 1742 (31·8%) of 5479 patients died in the intensive care unit and 2095 (38·3%) of 5465 patients died in hospital. Interpretation: In critically ill patients receiving at least 2 days of invasive mechanical ventilation, only 65% were weaned at 90 days. A better understanding of factors that delay the weaning process, such as delays in weaning initiation or excessive sedation levels, might improve weaning success rates. Funding: European Society of Intensive Care Medicine, European Respiratory Society