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.

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.

[Care work load in critical patients. Comparative study NEMS versus NAS]. / Cargas de trabajo asistencial en pacientes críticos. Estudio comparativo NEMS frente a NAS.

INTRODUCTION: The systems of calculating care load have not yet reached the levels of generalized use which the systems of prognostic estimation of survival have. The reason for this is their potential defects of design (medical and not nursing conceptualization) and the sometimes confusing completion (TISS 76). The simplest ("nine equivalents of nurse manpower use score" [NEMS], care levels) add the difficulty of not being useful for the calculation of staff, because the design is not oriented towards nursing. The development of NAS (nursing activity score) by FRICE tries to solve all these problems. Our objective has been to verify to what degree the NEMS and NAS are correlated as systems of expression and calculation of care load. PATIENTS AND METHOD: During the last quarter of 2004, NEMS and NAS have been used simultaneously by the nursing staff. During this period, 150 pairs of daily calculation values of NEMS-NAS and 150 pairs of calculation values by shift of NEMS-NAS have been collected. Comparison of means and linear correlation of values obtained and the analysis of the histograms of values of each series, their value ranges and analysis of their bias coefficients have been done. The analysis was done with the SPSS/PC 11. RESULTS: During the period indicated, it has been verified that NEMS has a much narrower value range than NAS, both in regards to daily values (18-45 versus 29.70-84.50) and in regards to values by shift (18-45 versus 22.40-84.50). The bias analysis shows a deviation to the left of both series of values. Linear correlation between NEMS-NAS by shift shows a R2 of 0.1634 and becomes even poorer in the NEMS-NAS correlation per day with R2 of 0.2012. It should also be stressed that NEMS expresses its results in points while NAS does so in percentage of time occupied in the attention and care of the patient. CONCLUSIONS: In this preliminary study, the better adaptation of NAS versus NEMS to real work loads of patients hospitalized in the ICU and the non-possible correlation between the values of both systems is affirmed.

Cargas de trabajo asistencial en pacientes críticos. Estudio comparativo NEMS frente a NAS / Care work load in critical patients. Comparative study NEMS versus NAS

Introducción. Los sistemas de cómputo de carga asistencial no han alcanzado aún los niveles de utilización generalizada que poseen los sistemas de estimación pronóstica de supervivencia. La causa de ello son sus potenciales defectos de diseño (conceptualización médica y no de enfermería) y la, a veces, farragosa cumplimentación (TISS 76). Los más simples (NEMS [nine equivalents of nursing manpower use score], niveles de asistencia) añaden la dificultad de no ser útil es para el cálculo de plantillas, debido a un diseño no orientado a enfermería. El desarrollo de NAS (nursing activity score) por FRICE® intenta solventar todos estos problemas. Nuestro objetivo ha sido comprobar en qué medida se correlacionan NEMS y NAS como sistemas de expresión y computo de carga asistencial. Pacientes y método. Durante el último trimestre de 2004 se han utilizado simultáneamente NEMS y NAS, por parte del personal de enfermería. Durante este período se han recogido 150 pares de valores de cómputo diario de NEMS-NAS y 150 pares de valores de cómputo por turno de NEMS-NAS. Se ha realizado la comparación de medias y la correlación lineal de valores obtenidos, así como el análisis de los histogramas de valores de cada serie, sus rangos de valor y el análisis de sus coeficientes de sesgo. El análisis se ha realizado mediante SPSS/PC 11. Resultados. Durante el período señalado se ha constatado que NEMS tiene un rango de valor mucho más estrecho que NAS, tanto en lo que se refiere a valores diarios (18-45 frente a 29,70-84,50) como a valores por turno (18-45 frente a 22,40-84,50). El análisis de sesgo muestra una desviación a la izquierda de ambas series de valores. La correlación lineal entre NEMS-NAS por turno, muestra una R2 de 0,1634, y se empobrece aún más en la correlación NEMS-NAS por día con R2 de 0,0212. Debe destacarse, además, que NEMS expresa sus resultados en puntos, mientras que NAS lo hace en porcentaje de tiempo ocupado en la atención y cuidado del paciente. Conclusiones. En este estudio preliminar se constata la mejor adecuación de NAS frente a NEMS a las reales cargas de trabajo de los pacientes ingresados en UCI y la no posible correlación entre los valores de ambos sistemas

Introduction. The systems of calculating care load have not yet reached the levels of generalized use which the systems of prognostic estimation of survival have. The reason for this is their potential defects of design (medical and not nursing conceptulalization) and the sometimes confusing completion (TISS 76). The simplest («nine equivalents of nurse manpower use score» [NEMS], care levels) add the difficulty of not being useful for the calculation of staff, because the design is not oriented towards nursing. The development of NAS (nursing activity score) by FRICE® tries to solve all these problems. Our objective has been to verify to what degree the NEMS and NAS are correlated as systems of expression and calculation of care load. Patients and method. During the last quarter of 2004, NEMS and NAS have been used simultaneously by the nursing staff. During this period, 150 pairs of daily calculation values of NEMS-NAS and 150 pairs of calculation values by shift of NEMS-NAS have been collected. Comparison of means and linear correlation of values obtained and the analysis of the histograms of values of each series, their value ranges and analysis of their bias coefficients have been done. The analysis was done with the SPSS/PC 11. Results. During the period indicated, it has been verified that NEMS has a much narrower value range than NAS, both in regards to daily values (18-45 versus 29.70-84.50) and in regards to values by shift (18-45 versus 22.40-84.50). The bias analysis shows a deviation to the left of both series of values. Linear correlation between NEMS-NAS by shift shows a R2 of 0.1634 and becomes even poorer in the NEMS-NAS correlation per day with R2 of 0.2012. It should also be stressed that NEMS expresses its results in points while NAS does so in percentage of time occupied in the attention and care of the patient. Conclusions. In this preliminary study, the better adaptation of NAS versus NEMS to real work loads of patients hospitalized in the ICU and the non-possible correlation between the values of both systems is affirmed

HAART with didanosine once versus twice daily: adherence and efficacy.

BACKGROUND: Highly active antiretroviral therapy (HAART) containing didanosine taken twice daily was compared with HAART containing didanosine taken once daily in terms of adherence and efficacy. METHOD: This was a self-controlled prospective cohort study, carried out in a tertiary level hospital. A total of 49 HIV-infected patients were included. They were prescribed HAART according to guidelines. After six months taking HAART containing didanosine twice daily, patients continued with the same regimen of HAART although once daily. Thereafter they were followed up for a further nine months. Adherence and virological efficacy were assessed at three-month intervals, for a total of six times, in every patient. RESULTS: Overall, adherence was poor, with only 19 patients (39%) showing adequate adherence for all six visits. Adequate adherence was observed in 29 patients (59%) three months before didanosine switching, and in 37 patients (75%) three months after didanosine switching (P=0.034). Pooled HIV RNA results of the first three visits were higher than the same results of the last three visits (P=0.05). CONCLUSIONS: Non-adherence is common among patients who take HAART. Simplification of regimens is useful to improve adherence and efficacy.

Primary non-hodgkin lymphoma of the larynx.

A rare case of primary large B-cell non-Hodgkin lymphoma of the larynx is reported. The patient was an 80-year-old female who presented with pharyngeal discomfort and dysphagia. Radiotherapy was instituted with complete remission of the tumor. Nine months afterward, she presented with aspiration pneumonia and dysphagia. Indirect laryngoscopy disclosed laryngeal and esophageal edema, which was probably related to radiotherapy. No signs of tumor recurrence were observed. Three months later, she was entirely asymptomatic. Although cases of aggressive course and poor response to therapy exist, primary large B-cell non-Hodgkin lymphoma of the larynx is generally considered a relatively benign and radiosensitive tumor.