The development and implementation of a low-cost mechanical ventilator in a low-middle-income country during the COVID-19 pandemic: The Unisabana-HERONS.

Background: The COVID-19 pandemic in Latin America generated the need to develop low-cost, fast-manufacturing mechanical ventilators. The Universidad de La Sabana and the Fundacion Neumologica Colombiana designed and manufactured the Unisabana-HERONS (USH) ventilator. Here, we present the preclinical and clinical study results to evaluate its effectiveness and safety characteristics in an animal model (Yorkshire Sow) and five patients with acute respiratory failure receiving mechanical ventilatory support for 24 h. Methods: The effectiveness and safety outcomes included maintaining arterial blood gases and pulse oximetry saturation (SpO2), respiratory pressures and volumes (during continuous monitoring) in the range of ARDS and lung-protective strategy goals, and the occurrence of barotrauma. A significance level of 0.05 was used for statistical tests. This clinical trial was registered on Clinicaltrials.gov (NCT04497623) and approved by the ethics committee. Results: Among patients treated with the Unisabana-HERONS, the most frequent causes of acute respiratory failure were pneumonia in 3/5 (60 %) and ARDS in 2/5 (40 %). During the treatment, the ventilatory parameters related to lung protection protocols were kept within the safety range, and vital signs and blood gas were stable. The percentage of time that the respiratory pressures or volumes were out of safety range were plateau pressure >30 cm H2O: 0.00 %; driving pressure >15 cm H2O: 0.06 %; mechanical power >15 J/min: 0.00 %; and Tidal volume >8 mL/kg: 0.00 %. There were no adverse events related to the ventilator. The usability questionnaire retrieved a median score for all items between 9 and 10 (best score: 10), indicating great ease of use. Conclusion: The Unisabana-HERONS ventilator effectively provided adequate gas exchange and maintained the ventilatory parameters in the range of lung protection strategies in humans and an animal model. Furthermore, it is straightforward to use and is a low-cost medical device.

Learning curves and association of pathologist's performance with the diagnostic accuracy of linear endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA): a cohort study in a tertiary care reference centre.

OBJECTIVES: We aimed to assess the learning curves and the influence of the pathologist's performance on the endobronchial ultrasound transbronchial needle aspiration's (EBUS-TBNA's) diagnostic accuracy in a real-world study. DESIGN/SETTING: Cohort study conducted in a tertiary care university hospital (single centre) with patients referred for EBUS-TBNA. PARTICIPANTS/INTERVENTION: We initially evaluated 376 patients (673 lymph nodes), 368 (660 lymph nodes) of whom were recruited. The inclusion criterion was EBUS-TBNA indicated for the study of mediastinal or hilar lesions. The exclusion criteria were the absence of mediastinal and hilar lesions during EBUS confirmed by a normal mediastinum and hilum on chest CT (except in cases of mediastinal staging of cancer) and lost to follow-up. PRIMARY AND SECONDARY OUTCOME MEASURES: Diagnostic accuracy and related outcomes. METHODS: We included patients from a prospectively constructed database. We performed a logistic regression multivariate analysis to adjust for potential confounders of the association between pathologist performance and EBUS-TBNA accuracy. The Cumulative Summation (CUSUM) analysis was used to assess pathologists' performance and learning curves. RESULTS: Most indications for EBUS were suspicion of malignancy, including intrathoracic tumours (68.3%), extrathoracic tumours (9.8%) and cancer staging (7.0%). The patients' mean age was 63.7 years, and 71.5% were male. Overall EBUS-TBNA accuracy was 80.8%. In the multivariate logistic regression model, the factors independently associated with EBUS-TBNA accuracy included certain pathologists (ORs ranging from 0.16 to 0.41; p<0.017), a lymph node short-axis diameter <1 cm (OR: 0.36; 95% CI 0.21 to 0.62; p<0.001), and the aetiology of lymph node enlargement (ORs ranging from 7 to 37; p<0.001). CUSUM analysis revealed four different learning curve patterns, ranging from almost immediate learning to a prolonged learning phase, as well as a pattern consistent with performance attrition. CONCLUSIONS: Pathologists' proficiency conditioned EBUS-TBNA accuracy. This human factor is a potential source of error independent of factors conditioning tissue sample adequacy.

Bronchoscopist's perception of the quality of the single-use bronchoscope (Ambu aScope4™) in selected bronchoscopies: a multicenter study in 21 Spanish pulmonology services.

BACKGROUND: The disposable bronchoscope is an excellent alternative to face the problem of SARS-CoV-2 and other cross infections, but the bronchoscopist's perception of its quality has not been evaluated. METHODS: To evaluate the quality of the Ambu-aScope4 disposable bronchoscope, we carried out a cross-sectional study in 21 Spanish pulmonology services. We use a standardized questionnaire completed by the bronchoscopists at the end of each bronchoscopy. The variables were described with absolute and relative frequencies, measures of central tendency and dispersion depending on their nature. The existence of learning curves was evaluated by CUSUM analysis. RESULTS: The most frequent indications in 300 included bronchoscopies was bronchial aspiration in 69.3% and the median duration of these was 9.1 min. The route of entry was nasal in 47.2% and oral in 34.1%. The average score for ease of use, image, and aspiration quality was 80/100. All the planned techniques were performed in 94.9% and the bronchoscopist was satisfied in 96.6% of the bronchoscopies. They highlighted the portability and immediacy of the aScope4TM to start the procedure in 99.3%, the possibility of taking and storing images in 99.3%. The CUSUM analysis showed average scores > 70/100 from the first procedure and from the 9th procedure more than 80% of the scores exceeded the 80/100 score. CONCLUSIONS: The aScope4™ scored well for ease of use, imaging, and aspiration. We found a learning curve with excellent scores from the 9th procedure. Bronchoscopists highlighted its portability, immediacy of use and the possibility of taking and storing images.

Frequency of emergency department visits and hospitalizations due to chronic obstructive pulmonary disease exacerbations in patients included in two models of care / Frecuencia de visitas al departamento de emergencias y hospitalizaciones debido a exacerbaciones de la enfermedad pulmonar obstructiva crónica en pacientes incluidos en dos modelos de atención

Introduction: Exacerbations of chronic obstructive pulmonary disease (COPD) have a huge impact on lung function, quality of life and mortality of patients. Emergency Department visits and hospitalizations due to exacerbations cause a significant economic burden on the health system. Objective: To describe the differences in the number of emergency visits and hospitalizations due to exacerbations of COPD among patients included in two models of care of the same institution. Materials and methods: A historical cohort study in which COPD patients who are users of two models of care were included: COPD integrated care program (CICP) and general consultation of pulmonology (GCP). The first model, unlike the second one, offers additional educational activities, 24/7 telephone service, and priority consultations. The number of emergency visits and hospitalizations due to COPD exacerbations in patients who had completed at least one year of follow-up was evaluated. The multivariable Poisson regression model was used for calculating the incidence rate (IR) and the incidence rate ratio (IRR) with an adjustment for confounding factors. Results: We included 316 COPD patients (166 from the CICP and 150 from the GCP). During the year of follow-up, the CICP patients had 50% fewer emergency visits and hospitalizations than patients from the GCP (IRR=0.50, 95%CI: 0.29-0.87, p=0.014). Conclusions: COPD patients in the CICP had fewer emergency visits and hospitalizations due to exacerbations. Prospective clinical studies are required to confirm the results and to evaluate the factors that contribute to the differences.

Introducción. Las exacerbaciones de la enfermedad pulmonar obstructiva crónica (EPOC) tienen un gran impacto en la función pulmonar, la calidad de vida y la mortalidad de los pacientes. Las visitas al Departamento de Emergencias y las hospitalizaciones debido a las exacerbaciones, causan una carga económica importante para el sistema de salud. Objetivo. Describir las diferencias en el número de visitas de emergencia y hospitalizaciones debidas a exacerbaciones de la EPOC, entre los pacientes incluidos en dos modelos de atención de la misma institución. Materiales y métodos. Se trata de un estudio de cohorte histórica en el que se incluyeron pacientes que son usuarios de dos modelos de atención: el programa de atención integrada de la EPOC (CICP) y la consulta general de neumología (PCG). El primer modelo, a diferencia del segundo, ofrece actividades educativas adicionales, servicio telefónico las 24 horas del día y consultas prioritarias. Se evaluó el número de visitas de emergencia y hospitalizaciones debido a exacerbaciones de la EPOC en pacientes que habían completado, al menos, un año de seguimiento. Se utilizó el modelo de regresión multivariable de Poisson para calcular la tasa de incidencia (IR) y la razón de tasas de incidencia (IRR), con un ajuste para factores de confusión. Resultados. Se incluyeron 316 pacientes con EPOC, 166 del CICP y 150 de la PCG. Durante el año de seguimiento, los pacientes en el CICP tuvieron 50 % menos visitas de emergencia y hospitalizaciones que los pacientes en la PCG (IRR=0,50; IC95% 0,29-0,87; p=0,014). Conclusiones. Los pacientes con EPOC en el CICP, tuvieron menos visitas de emergencia y hospitalizaciones debido a las exacerbaciones. Se requieren estudios clínicos prospectivos para confirmar los resultados y evaluar los factores que contribuyen a las diferencias.

Obstructive sleep apnea and nocturnal hypoxemia are associated with an increased risk of lung cancer.

STUDY OBJECTIVES: To identify a link between sleep disordered breathing, nocturnal hypoxemia, and lung cancer. METHODS: We conducted a cross-sectional study of a combined cohort of 302 individuals derived from the sleep apnea in lung cancer study (SAIL; NCT02764866) investigating the prevalence of sleep apnea in lung cancer, and the sleep apnea in lung cancer screening study (SAILS; NCT02764866) investigating the prevalence of sleep apnea in a lung cancer screening program. All subjects had spirometry and a chest CT, underwent home sleep apnea testing (HSAT), and completed a sleep related questionnaire. Subjects from the SAIL study underwent HSAT prior to initiating oncologic therapy or surgery. Subjects with an apnea-hypopnea index (AHI) > 15 were compared with a control group of individuals with an AHI < 15. Propensity score, near neighbor matching, and logistic regression adjusted for potential confounders, were used in order to evaluate the association between sleep apnea, the AHI, oxygen desaturation indices and lung cancer. RESULTS: The prevalence of sleep apnea and lung cancer in the combined cohort was 42% and 21%, respectively. Lung cancer was 8% more prevalent in patients with an AHI >15. The difference was statistically significant when assessed by propensity score matching (p = 0.015) and nearest neighbor matching (p = 0.041). Binary logistic regression adjusted for potential confounders revealed a statistically significant association between AHI (p = 0.04), nocturnal hypoxemia, including time spent below 90% oxyhemoglobin saturation (T90%; p = 0.005), 3% oxygen desaturation index (ODI3; p = 0.02) and lung cancer. CONCLUSIONS: Sleep apnea and nocturnal hypoxemia are associated with an increased prevalence of lung cancer. CLINICAL TRIAL REGISTRATION: SAIL study (NCT02764866) and SAILS study (NCT02764866).

Real-time PCR assay for the diagnosis of pleural tuberculosis.

INTRODUCTION: The diagnosis of pleural tuberculosis requires an invasive and time-consuming reference method. Polymerase chain reaction (PCR) is rapid, but validation in pleural tuberculosis is still weak. OBJECTIVE: To establish the operating characteristics of real-time polymerase chain reaction (RT-PCR) hybridization probes for the diagnosis of pleural tuberculosis. METHODS: The validity of the RT-PCR hybridization probes was evaluated compared to a composite reference method by a cross-sectional study at the Hospital Universitario de la Samaritana. 40 adults with lymphocytic pleural effusion were included. Pleural tuberculosis was confirmed (in 9 patients) if the patient had at least one of three tests using the positive reference method: Ziehl-Neelsen or Mycobacterium tuberculosis culture in fluid or pleural tissue, or pleural biopsy with granulomas. Pleural tuberculosis was ruled out (in 31 patients) if all three tests were negative. The operating characteristics of the RT-PCR, using the Mid-P Exact Test, were determined using the OpenEpi 2.3 Software (2009). RESULTS: The RT-PCR hybridization probes showed a sensitivity of 66.7% (95% CI: 33.2%-90.7%) and a specificity of 93.5% (95% CI: 80.3%-98.9%). The PPV was 75.0% (95% CI: 38.8%-95.6%) and a NPV of 90.6% (95% CI: 76.6%-97.6%). Two false positives were found for the test, one with pleural mesothelioma and the other with chronic pleuritis with mesothelial hyperplasia. CONCLUSIONS: The RT-PCR hybridization probes had good specificity and acceptable sensitivity, but a negative value cannot rule out pleural tuberculosis.

INTRODUCCIÓN: El diagnóstico de tuberculosis pleural requiere un método de referencia invasivo y demorado. La reacción en cadena de la polimerasa es rápida, pero su validación en tuberculosis pleural aún es débil. OBJETIVO: Establecer las características operativas de la reacción en cadena de la polimerasa en tiempo real (RT-PCR) sondas de hibridación para el diagnóstico de tuberculosis pleural. MÉTODOS: Se evaluó la validez de la RT-PCR sondas de hibridación comparada con un método de referencia compuesto mediante un estudio transversal en el Hospital Universitario de la Samaritana. Se incluyeron 40 adultos con derrame pleural linfocitario. Tuberculosis pleural fue confirmada (en 9 pacientes) si el paciente tenía mínimo una de tres pruebas del método de referencia positiva: Ziehl-Neelsen o cultivo para Mycobacterium tuberculosis en líquido o tejido pleural, o biopsia pleural con granulomas; se descartó tuberculosis pleural (en 31 pacientes) si las tres pruebas eran negativas. Se determinaron las características operativas de la RT-PCR, mediante la Prueba Mid-P Exact, con el Software OpenEpi 2.3 (2009). RESULTADOS: La RT-PCR sondas de hibridación mostró una sensibilidad del 66.7% (IC 95%: 33.2%-90.7%) y una especificidad del 93.5% (IC 95%: 80.3%-98.9%). El VPP fue de 75.0% (IC 95%: 38.8%-95.6%) y un VPN de 90.6% (IC 95%: 76.6%-97.6%). Se encontraron dos falsos positivos para la prueba, uno con mesotelioma pleural y otro con pleuritis crónica con hiperplasia mesotelial. CONCLUSIONES: La RT-PCR sondas de hibridación tuvo una buena especificidad y una aceptable sensibilidad, pero un valor negativo no puede descartar tuberculosis pleural.

Real-time PCR assay for the diagnosis of pleural tuberculosis / Reacción en cadena de la polimerasa en tiempo real para el diagnóstico de tuberculosis pleural

Abstract Introduction: The diagnosis of pleural tuberculosis requires an invasive and time-consuming reference method. Polymerase chain reaction (PCR) is rapid, but validation in pleural tuberculosis is still weak. Objective: To establish the operating characteristics of real-time polymerase chain reaction (RT-PCR) hybridization probes for the diagnosis of pleural tuberculosis. Methods: The validity of the RT-PCR hybridization probes was evaluated compared to a composite reference method by a cross-sectional study at the Hospital Universitario de la Samaritana. 40 adults with lymphocytic pleural effusion were included. Pleural tuberculosis was confirmed (in 9 patients) if the patient had at least one of three tests using the positive reference method: Ziehl-Neelsen or Mycobacterium tuberculosis culture in fluid or pleural tissue, or pleural biopsy with granulomas. Pleural tuberculosis was ruled out (in 31 patients) if all three tests were negative. The operating characteristics of the RT-PCR, using the Mid-P Exact Test, were determined using the OpenEpi 2.3 Software (2009). Results: The RT-PCR hybridization probes showed a sensitivity of 66.7% (95% CI: 33.2%-90.7%) and a specificity of 93.5% (95% CI: 80.3%-98.9%). The PPV was 75.0% (95% CI: 38.8%-95.6%) and a NPV of 90.6% (95% CI: 76.6%-97.6%). Two false positives were found for the test, one with pleural mesothelioma and the other with chronic pleuritis with mesothelial hyperplasia. Conclusions: The RT-PCR hybridization probes had good specificity and acceptable sensitivity, but a negative value cannot rule out pleural tuberculosis.

Resumen Introducción: El diagnóstico de tuberculosis pleural requiere un método de referencia invasivo y demorado. La reacción en cadena de la polimerasa es rápida, pero su validación en tuberculosis pleural aún es débil. Objetivo: Establecer las características operativas de la reacción en cadena de la polimerasa en tiempo real (RT-PCR) sondas de hibridación para el diagnóstico de tuberculosis pleural. Métodos: Se evaluó la validez de la RT-PCR sondas de hibridación comparada con un método de referencia compuesto mediante un estudio transversal en el Hospital Universitario de la Samaritana. Se incluyeron 40 adultos con derrame pleural linfocitario. Tuberculosis pleural fue confirmada (en 9 pacientes) si el paciente tenía mínimo una de tres pruebas del método de referencia positiva: Ziehl-Neelsen o cultivo para Mycobacterium tuberculosis en líquido o tejido pleural, o biopsia pleural con granulomas; se descartó tuberculosis pleural (en 31 pacientes) si las tres pruebas eran negativas. Se determinaron las características operativas de la RT-PCR, mediante la Prueba Mid-P Exact, con el Software OpenEpi 2.3 (2009). Resultados: La RT-PCR sondas de hibridación mostró una sensibilidad del 66.7% (IC 95%: 33.2%-90.7%) y una especificidad del 93.5% (IC 95%: 80.3%-98.9%). El VPP fue de 75.0% (IC 95%: 38.8%-95.6%) y un VPN de 90.6% (IC 95%: 76.6%-97.6%). Se encontraron dos falsos positivos para la prueba, uno con mesotelioma pleural y otro con pleuritis crónica con hiperplasia mesotelial. Conclusiones: La RT-PCR sondas de hibridación tuvo una buena especificidad y una aceptable sensibilidad, pero un valor negativo no puede descartar tuberculosis pleural.

Accuracy of endoscopic and videofluoroscopic evaluations of swallowing for oropharyngeal dysphagia.

OBJECTIVES: A systematic review and meta-analysis of the literature was conducted to compare the accuracy with which flexible endoscopic evaluation of swallowing (FEES) and videofluoroscopic swallowing study (VFSS) assessed oropharyngeal dysphagia in adults. DATA SOURCES: PubMed, Embase, and the Latin American and Caribbean Health Sciences Literature (LILACS) database. METHODS: A review of published studies was conducted in parallel by two groups of researchers. We evaluated the methodological quality, homogeneity, threshold effect, and publication bias. The results are presented as originally published, then with each test compared against the other as a reference and both compared against a composite reference standard, and then pooled using a random effects model. Software use consisted of Meta-DiSc and SPSS. RESULTS: The search yielded 5,697 articles. Fifty-two articles were reviewed in full text, and six articles were included in the meta-analysis. FEES showed greater sensitivity than VFSS for aspiration (0.88 vs. 0.77; P = .03), penetration (0.97 vs. 0.83; P = .0002), and laryngopharyngeal residues (0.97 vs. 0.80; P < .0001). Sensitivity to detect pharyngeal premature spillage was similar for both tests (VFSS: 0.80; FEES: 0.69; P = .28). The specificities of both tests were similar (range, 0.93-0.98). In the sensitivity analysis there were statistically significant differences between the tests regarding residues but only marginally significant differences regarding aspiration and penetration. CONCLUSIONS: FEES had a slight advantage over VFSS to detect aspiration, penetration, and residues. Prospective studies comparing both tests against an appropriate reference standard are needed to define which test has greater accuracy. LEVEL OF EVIDENCE: 2a Laryngoscope, 127:2002-2010, 2017.

Escalas de calidad de vida y valoración de los síntomas en disfagia / Scales of quality of life and assessment of symptoms in dysphagia / Escalas de qualidade de vida e avaliação dos síntomas em disfagia

La disfagia es un síntoma que tiene repercusiones en la calidad de vida de cualquier individuo que la padezca. Asimismo puede asociarse a varias complicaciones respiratorias y nutricionales que van a impactar en los diferentes ámbitos psicosociales. Por esta razón se han establecido parámetros para evaluar la calidad de vida de los pacientes con este diagnóstico. Por otro lado es importante reconocer los síntomas que caracterizan la disfagia para que ésta sea detectada de manera oportuna por el personal de salud. Es por ello que también se han desarrollado escalas para este fin. Las escalas de calidad de vida y de evaluación de síntomas son instrumentos de evaluación importantes porque proporcionan información valiosa al médico tratante acerca de la percepción del estado de salud actual del paciente, los síntomas clave y los efectos de la intervención terapéutica. En este trabajo se describen las características y propiedades psicométricas de los instrumentos existentes para la evaluación de la calidad de vida y la valoración de los síntomas de los pacientes con disfagia.

Dysphagia it is a symptom with repercussions in life quality of any individual who suffer it. In the same way, it could be related to many respiratory and nutritional complications that will have an impact in different psychosocial aspects. For this reason it has been established parameters in order to evaluate the life quality of the patients with this condition. On the other hand, it is important to recognize the characteristic symptoms of dysphagia in order to be detected appropriately by the health community, for which reason has been also the development of scales. The life quality scales and the evaluation of symptoms are important instruments because provides valuable information to the doctor in charge about the perception of the current health condition of the patients, the key symptoms and the effects of a therapeutic intervention. In this paper we describe the characteristics and psychometric properties of the instruments available to the evaluation of life quality and the assessment of the symptoms of the patients with dysphagia.

A disfagia é um sintoma que tem repercussão na qualidade da vida de qualquer pessoa que sofra dela. Assim mesmo pode estar associada com algumas complicações respiratórias y nutricionais que impactaram nos diferentes âmbitos psicossociais. Por essa ração estabeleceram-se parâmetros para avaliar a qualidade de vida dos pacientes com esse diagnóstico. Por outro lado é importante reconhecer os sintomas que caracterizam a disfagia para que esta seja detectada de maneira oportuna pelo equipe de saúde. É por ele que também se tem desenvolvido escalas para isso. As escalas de qualidade de vida e de evacuação de sintomas são instrumentos de avaliação importantes por que dão informação valiosa ao médico encargado da percepção do estado de saúde do paciente, os sintomas chaves e os efeitos da intervenção terapêutica. Este paper descreve as características e propriedades psicométricas dos instrumentos para avaliação da qualidade da vida e valoração dos sintomas dos pacientes com disfagia.

Muerte, eutanasia y cuidados paliativos / Death, Euthanasia and Palliative Care

La persona humana posee, en potencia o en acto, una inteligencia capaz de realizar operaciones abstractas; una voluntad capaz de amar el bien, y una libertad que le permite determinar su manera de obrar (o de no obrar). Estas características, inherentes al ser de la persona humana, se derivan de la unidad sustancial que existe entre el alma espiritual y el cuerpo, y la dotan de una dignidad especial que debe reflejarse en la forma como afronta toda su existencia, y como es tratada y respetada por los demás.En efecto, la dignidad de la persona humana le confiere unos derechos y deberes entre los cuales se encuentra, de manera primordial, el respeto incondicionado a la vida humana inocente (tanto propia como ajena). Por este motivo, la muerte del ser humano y el periodo próximo a la misma requieren de un profundo respeto y de un tratamiento acorde con esa dignidad, que le permitan afrontar esta etapa con el máximo decoro e integridad.Mientras que la eutanasia representa una manera de afrontar la muerte que desconoce la inviolabilidad de la vida humana y, por tanto, atenta contra la dignidad de la persona, los cuidados paliativos hoy día cuentan con herramientas muy eficaces para aliviar el sufrimiento y acompañar al ser humano en esta crucial etapa de la vida en consonancia con la dignidad de la que está revestido.