Comparison of Two Extubation Techniques in Critically Ill Adult Subjects: The ExtubAR Randomized Clinical Trial.

BACKGROUND: Two orotracheal extubation techniques are described in the literature: the traditional technique and the positive-pressure technique. Although prior studies reported better clinical outcomes with the positive-pressure extubation technique, its superiority has not been extensively studied yet. This study was to determine whether the positive-pressure orotracheal extubation technique, compared with the traditional orotracheal extubation technique, reduces the incidence of major postextubation complications (up to 60 min) in critically ill adult subjects. METHODS: This was a multi-center randomized clinical trial. Subjects age > 18 y, requiring invasive mechanical ventilation through an endotracheal tube, who met the orotracheal extubation criteria were included and randomized to traditional extubation group (removing the endotracheal tube by applying continuous endotracheal suctioning during the entire procedure) or positive-pressure group (application of pressure support mode at 15/10 cm H2O during cuff deflation and extubation). The primary measure was postextubation major complications, defined as the clinical evidence of at least one of the following: desaturation, upper-airway obstruction, or vomiting. RESULTS: A total of 725 subjects was randomly assigned to the traditional extubation group (n = 358) and positive-pressure group (n = 367). Seventeen subjects were eliminated and not included in the per-protocol analysis. Of 708 subjects, 185 (26.1%) developed at least one major complication. The incidence was 27.8% (96/345) in the traditional group compared with 24.5% (89/363) in the positive-pressure group. No statistically significant differences were observed between the 2 groups (absolute risk 3% [95 CI -3 to 10]; relative risk, 0.88 [95 CI 0.69-1.13], P = .32). CONCLUSIONS: Despite the trend toward the positive-pressure group, no statistically significant differences were observed. Our findings agree with the literature in that positive-pressure extubation is a safe procedure; therefore, both techniques may be used during extubation in critically ill adult patients.

Impacto de la implementación de medidas de cuidados respiratorios y optimización de la ventilación mecánica en potenciales donantes de pulmón / Impact of implementing a protocol of respiratory care measures and optimization of mechanical ventilation in potential lung donors

RESUMEN Objetivo: Describir los resultados de la implementación de un protocolo de cuidados respiratorios y de ventilación mecánica en el potencial donante de pulmón, que cumplen las condiciones para ser procurados. El objetivo secundario es comparar los resultados con datos históricos. Métodos: Estudio retrospectivo y observacional. Incluye potenciales donantes aptos para procuración de órganos con muerte encefálica internados en las áreas críticas de la Ciudad Autónoma de Buenos Aires, desde abril de 2017 hasta marzo de 2018. Variables principales: número de potencial donante de pulmón que alcanzan el objetivo de procuración, tasa de pulmones procurados y tasa de pulmones implantados. Se consideraron valores significativos p < 0,05. Resultados: Se incluyeron 30 potenciales donantes de pulmón, 23 (88.5%; IC95% 69,8 - 97,6) cumplieron el objetivo de oxigenación. Veinte potenciales donantes de pulmón donaron órganos y de ellos, ocho donaron pulmones, con los cuales se realizaron 4 trasplantes bipulmonares y 8 unipulmonares. Los pulmones procurados e implantados en el periodo pre-protocolo fueron 7, mientras que durante el protocolo fueron 12 (valor p = 0,38). La tasa de implantación fue 58,3% (7/12) en el control histórico y 100% (12/12) (valor p = 0,04) en el periodo de estudio. Conclusión: El protocolo permitió alcanzar el objetivo de oxigenación en la mayoría de los potenciales donantes de pulmón y una mejoría estadísticamente significativa en la tasa de implantación.

ABSTRACT Objective: To describe the results from the implementation of a respiratory care and mechanical ventilation protocol on potential lung donors who met the conditions for procurement. The secondary objective is to compare the results with historical data. Methods: This was a retrospective, observational study. It included potential donors suitable for procurement of organs who had brain death and were hospitalized in critical care units of the Autonomous City of Buenos Aires from April 2017 to March 2018. Main variables: number of potential lung donors that reached the objective of procurement, rate of lungs procured, and rate of implanted lungs. Values of p < 0.05 were considered significant. Results: Thirty potential lung donors were included, and 23 (88.5%; 95%CI 69.8 - 97.6) met the oxygenation objective. Twenty potential lung donors donated organs, of whom eight donated lungs, with which four double lung transplants and eight single lung transplants were performed. Seven of 12 lungs were procured and implanted in the preprotocol period, while all 12 were under the protocol (p = 0.38). The implantation rate was 58.3% (7/12) in the historical control period and 100% (12/12) (p = 0.04) in the study period.

Impact of implementing a protocol of respiratory care measures and optimization of mechanical ventilation in potential lung donors. / Impacto de la implementación de medidas de cuidados respiratorios y optimización de la ventilación mecánica en potenciales donantes de pulmón.

OBJECTIVE: To describe the results from the implementation of a respiratory care and mechanical ventilation protocol on potential lung donors who met the conditions for procurement. The secondary objective is to compare the results with historical data. METHODS: This was a retrospective, observational study. It included potential donors suitable for procurement of organs who had brain death and were hospitalized in critical care units of the Autonomous City of Buenos Aires from April 2017 to March 2018. Main variables: number of potential lung donors that reached the objective of procurement, rate of lungs procured, and rate of implanted lungs. Values of p < 0.05 were considered significant. RESULTS: Thirty potential lung donors were included, and 23 (88.5%; 95%CI 69.8 - 97.6) met the oxygenation objective. Twenty potential lung donors donated organs, of whom eight donated lungs, with which four double lung transplants and eight single lung transplants were performed. Seven of 12 lungs were procured and implanted in the preprotocol period, while all 12 were under the protocol (p = 0.38). The implantation rate was 58.3% (7/12) in the historical control period and 100% (12/12) (p = 0.04) in the study period.

OBJETIVO: Describir los resultados de la implementación de un protocolo de cuidados respiratorios y de ventilación mecánica en el potencial donante de pulmón, que cumplen las condiciones para ser procurados. El objetivo secundario es comparar los resultados con datos históricos. MÉTODOS: Estudio retrospectivo y observacional. Incluye potenciales donantes aptos para procuración de órganos con muerte encefálica internados en las áreas críticas de la Ciudad Autónoma de Buenos Aires, desde abril de 2017 hasta marzo de 2018. Variables principales: número de potencial donante de pulmón que alcanzan el objetivo de procuración, tasa de pulmones procurados y tasa de pulmones implantados. Se consideraron valores significativos p < 0,05. RESULTADOS: Se incluyeron 30 potenciales donantes de pulmón, 23 (88.5%; IC95% 69,8 - 97,6) cumplieron el objetivo de oxigenación. Veinte potenciales donantes de pulmón donaron órganos y de ellos, ocho donaron pulmones, con los cuales se realizaron 4 trasplantes bipulmonares y 8 unipulmonares. Los pulmones procurados e implantados en el periodo pre-protocolo fueron 7, mientras que durante el protocolo fueron 12 (valor p = 0,38). La tasa de implantación fue 58,3% (7/12) en el control histórico y 100% (12/12) (valor p = 0,04) en el periodo de estudio. CONCLUSIÓN: El protocolo permitió alcanzar el objetivo de oxigenación en la mayoría de los potenciales donantes de pulmón y una mejoría estadísticamente significativa en la tasa de implantación.

Safety of Positive Pressure Extubation Technique.

BACKGROUND: Laboratory studies suggest applying positive pressure without endotracheal suction during cuff deflation and extubation. Although some studies reported better physiological outcomes (e.g. arterial blood gases) with this technique, the safety of positive pressure extubation technique has not been well studied. The aim of this study was to determine the safety of the positive-pressure extubation technique compared with the traditional extubation technique in terms of incidence of complications. METHODS: Adult subjects who were critically ill and on invasive mechanical ventilation who met extubation criteria were included. The subjects were randomly assigned to positive-pressure extubation (n = 120) or to traditional extubation (n = 120). Sequential tests for noninferiority and, when appropriate, for superiority were performed. Positive pressure was considered noninferior if the upper limit of the CI for the absolute risk difference did not exceed a threshold of 15% in favor of the traditional group, both in per protocol and intention-to-treat analyses. A P value of <.05 was considered significant. RESULTS: A total of 236 subjects were included in the primary analysis (per protocol) (119 in the positive-pressure group and 117 in the traditional group). The incidence of overall major and minor complications, pneumonia, extubation failure, and reintubation was lower in the positive-pressure group than in the traditional group, with statistical significance for noninferiority both in the per protocol (P < .001) and intention-to-treat (P < .001) analyses. The lower incidence of major complications found in the positive-pressure group reached statistical significance for the superiority comparison, both in per protocol (P = .03) and intention-to-treat (P = .049) analyses. No statistically significant differences were found in the superiority comparison for overall complications, minor complications, pneumonia, extubation failure, and reintubation. CONCLUSIONS: Positive pressure was safe and noninferior to traditional extubation methods. Furthermore, positive pressure has shown to be superior in terms of a lower incidence of major complications. (ClinicalTrials.gov registration NCT03174509.).

Características de los pacientes desvinculados de la ventilación mecánica invasiva: Un estudio multicéntrico / Characteristics of Patients Weaning From Invasive Mechnical Ventilation. A multicenter Study

El proceso de weaning incluye la liberación del paciente del soporte ventilatorio y del tubo orotraqueal y se clasifica en simple, dificultoso y prolongado, basado en la dificultad y la duración del mismo. El objetivo fue describir las características epidemiológicas de pacientes desvinculados exitosamente de la ventilación mecánica invasiva y establecer asociaciones entre los tipos de weaning y las variables que influyeron en la evolución de las mismas asociadas a la mortalidad. Realizamos un estudio de cohorte prospectivo, analítico, longitudinal y multicéntrico en tres unidades de terapia intensiva de la Ciudad Autónoma de Buenos Aires, Argentina. Fueron incluidos sujetos que requirieron ventilación mecánica invasiva mayor a 12hs. y desvinculados exitosamente. Las variables estudiadas fueron tipo de weaning, tiempo en ventilación mecánica invasiva, falla de extubación, estadía y mortalidad en terapia intensiva. La prevalencia del weaning simple, dificultoso y prolongado correspondió a un 52.2% (95/182), 25.8% (47/182) y 22% (40/182), respectivamente. Aumentó el promedio de días de ventilación mecánica invasiva a 3,5 cada vez que cambió la categoría (Coefciente B: 3.5; SE 0.6). Aquellos pacientes que fallaron la extubación presentaron mayor riesgo de realizar weaning prolongado ( OR = 23; IC95%: 3.55-149.45). No se halló asociación entre la mortalidad y el tipo de weaning (OR = 0.68; IC95%: 0.31-1.51). En conclusión, no se asoció el tipo de weaning con mortalidad en la terapia intensiva. La falla de extubación, la traqueostomia y la presencia de delirio se asociaron con mayores días de ventilación mecánica invasiva.

The weaning process includes the release from the ventilatory support and endotracheal tube. It is classified into simple, difficult and prolonged, according to its difficulty and duration. The purpose was to describe the epidemiological characteristics of patients successfully weaned from invasive mechanical ventilation and establish associations between the different types of weaning and the variables influencing the evolution of these characteristics associated with mortality. We conducted a multicenter, prospective, longitudinal, analytical cohort study in three intensive care units of the Autonomous City of Buenos Aires, Argentina. We included patients who required invasive mechanical ventilation for more than 12 hours and were successfully weaned from it. The variables to be analyzed were: type of weaning, amount of days the patients received invasive mechanical ventilation, extubation failure and length of stay and mortality in the intensive care unit. The prevalence of simple, difficult or prolonged weaning was 52.2% (95/182), 25.8% (47/182) and 22% (40/182), respectively. The average of days the patients received invasive mechanical ventilation increased to 3.5 every time the category changed (B Coefficient: 3.5; SE [standard error] = 0.6). Patients with extubation failure presented a higher risk of prolonged weaning (OR [odds ratio] = 23; CI [confidence interval] = 95%: 3.55-149.45). No association was found between mortality and type of weaning (OR = 0.68; 95% CI: 0.31-1.51). In conclusion, the type of weaning was not associated with mortality in the intensive care unit. The extubation failure, tracheostomy and presence of delirium were associated with a larger amount of days receiving invasive mechanical ventilation.