COVOX: Providing oxygen during the COVID-19 health emergency.

We introduce an autonomous oxygen concentrator that was designed in Peru to fight the oxygen shortage produced worldwide as a consequence of the COVID-19 pandemic. Oxygen concentrators represent a suitable and favorable option for administering this gas at the patient's bedside in developing countries, especially when cylinders and tubed systems are unavailable or when access to them is restricted by lack of accessories, inadequate power supply, or shortage of qualified personnel. Our system uses a pressure swing adsorption technique to provide oxygen to patients at a flow rate of up to 15 l/min ± 1,5 l/min and a concentration of 93 % ± 3 %, offering robustness, safety and functionality. The quality measurements obtained from the validation process demonstrate repeatability and accuracy. The complete design files are provided in the source file repository to facilitate oxygen concentrator production in low and middle income countries, where access to oxygen is still a major problem even after the pandemic. Oxygen is part of the World Health Organization Model List of Essential Medicines and is perhaps the only medicine that has no substitute. This device can provide a reliable supply of oxygen for critically ill patients and improve their chances of survival.

Extension of Non-invasive Ventilation Capabilities of MASI for the Care of Patients Affected by COVID-19.

The MASI mechanical ventilator was developed in a state of emergency to meet the demand for ventilators caused by COVID-19. Although it has obtained positive results in its use with patients in intensive care units, not having an optimal quality non-invasive ventilation (NIV) modality prevents it from being used in the early treatment of patients, which has been shown to prevent admission to the ICU and reduce mortality. Therefore, the following study focuses on evaluating MASI's ability to provide NIV using different accessories in order to compare their performance and determine which one would work best with MASI, and under which conditions. To do this, the high-flow nasal cannula, facial mask, and ventilation helmet accessories were tested under different pressure parameter settings. The data was collected using a gas flow analyzer. After that, a statistical analysis of the results was carried out, which showed that the face mask is the best accessory to use for NIV with MASI, and that it performs with optimal accuracy and precision when the peak inspiratory pressure is set at a value lower than 25 cmH20. Clinical Relevance- This study presents an optimization of the non-invasive ventilation (NIV) modality of the MASI me-chanical ventilator by evaluating its performance with different accessories.

Quality characteristics of the Masi Peruvian mechanical ventilator manufacturing process.

Three hundred and ten rapid-manufactured mechanical ventilators, named Masi, were produced and validated in Peru, according to applicable standards. From these, a sample of 30 was taken and two ventilation parameters, tidal volume and peak inspiratory pressure, were statically analyzed using control charts and histograms. Results show that several points were outside estimated limits for Shewhart means and ranges charts, which could possibly be due to the quantity of equipment used for data recollection and the fact that the Masi team had over 20 engineers. Nevertheless, Masi ventilators met the tolerance required by their user´s manual and MHRA standard and Peruvian DIGEMID for every parameter.Clinical Relevance-This article shows the performance in the validation stage of the peruvian mechanical ventilator MASI built as an emergency response for the COVID-19 crisis.

Performance of the Masi Peruvian ventilator at high altitude.

In response to Covid-19 crisis, 310 Masi ventilators were produced and validated in Lima, Peru, according to applicable standards. Four of them, were transported to Puno, in order to strengthen ICU Services there, but this set a major challenge to Masi team as effects of altitude on ventilators were unknown. Once there, ventilators were acclimated and calibrated. Volume tidal, I:E ratio, respiratory frequency and PEEP were tested, all of them presenting errors under 15%, except for tidal volume, for which a 25% negative correction was applied. After the installation of a new version of Masi software, parameters were tested again, all of them presenting results with errors below 15%, which allowed the Masi team to take them to ICU services for use.Clinical Relevance- Masi Peruvian Ventilators are able to perform according to their specifications at extremely high altitude, after the adequate calibration. These devices are an alternative to treat COVID-19 patients in the middle of the crisis.

Martin's, Friedewald's and Cordova's formulas compared to LDL-C directly measured in Southern Brazil / Fórmulas de Martin, Friedewald e Cordova comparadas com a dosagem direta do LDL-C no sul do Brasil

ABSTRACT Introduction: Recently, fasting flexibility for laboratory determination of lipid profile has been recommended. When triglycerides (TG) are above 400 mg/dl, the formula proposed by Martin et al. should be used to estimate the low-density lipoprotein cholesterol (LDL-C). However, this formula has not been evaluated in our population. Objectives: We evaluated the performance of Martin's equation for LDL-C estimation compared to Cordova & Cordova and Friedewald formulas in a population of Southern Brazil. Methods: Sampling consisted of 10,664 Brazilian individuals (5,847 women) aged 1 to 93 years, with TG, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C) and LDL-C directly measured. Results: Martin's formula presented significantly higher LDL-C values in patients with TG < 300 mg/dl, underestimating values when TG > 400 mg/dl, even with negative values; and LDL-C values was also overestimated in all TC ranges, with greater standard deviation. It also presented a higher mean error in the stratified intervals, and a lower correlation coefficient. Conclusion: Martin's equation is not accurate for estimating LDL-C in our sample, unless TG is between 300 and 400 mg/dl. We recommend using the Cordova & Cordova formula as an alternative to determine LDL-C when its direct measurement is not available, and not applying the Martin's Formula indiscriminately to other populations before it is properly evaluated and compared with other available equations.

RESUMEN Introducción: Recientemente, se ha recomendado la flexibilización del ayuno para la determinación del perfil lipídico. Cuando los triglicéridos (TG) estén por encima de 400 mg/dl, se debe utilizar la fórmula propuesta por Martin et al. para estimar el colesterol de la lipoproteína de baja densidad (LDL-C); sin embargo, esa fórmula no ha sido analizada en nuestra población. Objetivos: Evaluamos el desempeño de la ecuación de Martin para estimar el LDL-C en comparación con las fórmulas de Cordova y Cordova, y Friedewald en una población de la región Sur de Brasil. Métodos: La muestra se compuso de 10.664 individuos brasileños (5.847 mujeres) con edades entre 1 y 93 años, con TG, colesterol total (CT), colesterol de la lipoproteína de alta densidad (HDL-C) y LDL-C medidos directamente. Resultados: La fórmula de Martin presentó valores notablemente más altos de LDL-C en pacientes con TG < 300 mg/dl, subestimando los niveles cuando TG > 400 mg/dl, incluso con valores negativos; también el LDL-C fue sobrevalorado en todos los rangos de CT, con mayor desviación estándar. Además presentó un error medio mayor en los intervalos estratificados y un menor coeficiente de correlación. Conclusión: La ecuación de Martin no tiene exactitud para estimar el LDL-C en nuestra muestra, a menos que el TG esté entre 300 y 400 mg/dl. Recomendamos que la fórmula de Cordova y Cordova sea utilizada como una alternativa para determinar el LDL-C cuando su medida no esté disponible, y que la fórmula de Martin no sea empleada indiscriminadamente en otras poblaciones sin ser adecuadamente evaluada y comparada con otras ecuaciones disponibles.

RESUMO Introdução: Recentemente, foi recomendada a flexibilização do jejum para a determinação laboratorial do perfil lipídico. Quando os triglicerídeos (TG) estiverem acima de 400 mg/dl, deve ser utilizada a fórmula proposta por Martin et al. para a estimativa do colesterol da lipoproteína de baixa densidade (LDL-C), contudo, essa fórmula não foi avaliada em nossa população. Objetivos: Avaliamos o desempenho da equação de Martin para a estimativa do LDL-C em comparação com as fórmulas de Cordova & Cordova e Friedewald em uma população da região sul do Brasil. Métodos: A amostragem foi composta por 10.664 indivíduos brasileiros (5.847 mulheres) com idades entre 1 e 93 anos, com TG, colesterol total (CT), colesterol da lipoproteína de alta densidade (HDL-C) e LDL-C medidos diretamente. Resultados: A fórmula de Martin apresentou valores significativamente mais altos de LDL-C em pacientes com TG < 300 mg/dl, subestimando os valores quando TG > 400 mg/dl, inclusive com valores negativos; também foi superestimado o LDL-C em todas as faixas de CT, com maior desvio padrão. Ainda apresentou um erro médio maior nos intervalos estratificados e um menor coeficiente de correlação. Conclusão: A equação de Martin não tem acurácia para a estimativa do LDL-C em nossa amostragem, a menos que o TG esteja entre 300 e 400 mg/dl. Recomendamos que a fórmula Cordova & Cordova seja utilizada como uma alternativa para determinar o LDL-C quando sua medida direta não estiver disponível e que a fórmula de Martin não seja aplicada indiscriminadamente em outras populações sem ser adequadamente avaliada e comparada com outras equações disponíveis.

Comparison of LDL-cholesterol direct measurement with the estimate using the Friedewald formula in a sample of 10,664 patients.

OBJECTIVE: To compare direct measurement of LDL-cholesterol (LDL-C) determined by a homogeneous method with LDL-cholesterol estimation determined by the Friedewald formula in a large heterogeneous population. METHODS: The measurements of total cholesterol (TC) and triglycerides (TG) were performed using traditional enzymatic methods. The measurements of HDL-C and LDL-C were performed using direct methods with no precipitation, and the estimation of the LDL-C fraction was calculated using the Friedewald formula. RESULTS: On linear regression analysis, the 2 methods had extremely significant correlation coefficients (P < 0.001). However, the Friedewald formula had a positive bias in regard to the direct method, more pronounced with TC levels > 201 mg/dL. This positive bias also occurred in regard to TG levels < or =150 mg/dL. No bias was observed between the methods for TG levels ranging from 151 to 200 mg/dL and from 201 to 300 mg/dL. On the other hand, for TG levels ranging from 301 to 400 mg/dL, this bias of the Friedewald formula became negative. CONCLUSION: The Friedewald formula did not have a homogeneous performance for estimating LDL-C levels in samples with different TG levels as compared with that of the direct method, what could launch doubts on patients classification on the risk of developing coronary artery disease.

A new accurate, simple formula for LDL-cholesterol estimation based on directly measured blood lipids from a large cohort.

BACKGROUND: Low-density lipoprotein cholesterol (LDL-c) is the major measured parameter for cardiovascular risk assessment. The generally accepted formula (LDL-F) for estimating LDL-c developed by Friedewald and colleagues in 1972 using data from 448 individuals suffers from known inaccuracies at extremes of triglyceride (TG) and total cholesterol (TC) values. METHODS: We generated new formulas based on a large Brazilian database containing directly measured lipid values from 10,664 fasted individuals. This database LDL-c was measured by the LDL-C Select FS (DiaSys) system, a homogeneous method without centrifugation. The formulas were generated using linear and non-linear approaches, and the formula with the highest accuracy and simplicity for general clinical use was selected. RESULTS: The simple formula LDL-c = 3/4 (TC - HDL-c) provided an accurate estimate of LDL-c, a higher correlation with directly measured LDL (r = 0.93) compared with LDL-F (r = 0.87), and also a higher accuracy. CONCLUSIONS: The new formula outperformed several other LDL-c formulas over a wide range of TC, HDL-c and TG values. The validation and application of this formula in other populations is warranted.

Determinação das glicemias capilar e venosa com glicosímetro versus dosagem laboratorial da glicose plasmática / Determination of capillary blood glucose and venous blood glucose with a glucometer versus laboratory determination of venous plasma glucose

INTRODUÇÃO E OBJETIVOS: Diabetes mellitus (DM) é a mais importante patologia que envolve o pâncreas endócrino, sendo uma das principais causas de morbidade e mortalidade na população geral. O objetivo deste trabalho foi avaliar a determinação da glicemia em diferentes tipos de amostras e metodologias. MÉTODOS: Utilizando um equipamento Accu-Check Advantage (Roche), foi avaliada a glicemia em amostras de sangue capilar (GCG) e de sangue venoso (GVG), e a dosagem da glicemia venosa em plasma (GVE) foi realizada por método enzimático de rotina. RESULTADOS E CONCLUSÃO: Foi observada boa correlação entre a GCG e a GVG (r = 0,8742). Entretanto, houve diferença significativa entre a GCG e a GVE (r = 0,6543) e entre a GVG e a GVE (r = 0,5038) (p < 0,001). Essa diferença é maior considerando-se apenas os pacientes normoglicêmicos. O fato de haver diferentes estudos com resultados conflitantes entre si não depende somente da marca ou série específica do glicosímetro, já que uma mesma marca pode apresentar resultados inconsistentes em diferentes estudos.

INTRODUCTION AND OBJECTIVES: Diabetes mellitus is the most important pathology that affects the endocrine pancreas and one of the main causes of morbidity and mortality among the general population. The aim of this work was to evaluate the correlation of blood glucose determination in different types of samples and methodologies. METHODS: Using an Accu-Check Advantage glucometer (Roche), it was determined the blood glucose levels in capillary (CBG) and venous (VBG) samples, and plasma venous glucose was determined by routine enzymatic methodology (EVG). RESULTS AND CONCLUSION: It was observed a good correlation between CBG and VBG (r = 0.8742). However, there was a significant difference between CBG and EVG (r = 0.6543) and between VBG and EVG (r = 0.5038) (p < 0.001). These differences are even more substantial considering only normoglycemic patients. The existence of different studies with inconsistent results does not depend only on the glucometer brand or its specific series, as the same device may present inconsistent results in different studies.

Avaliação da dosagem direta do colesterol-LDL em amostras de sangue de 10.664 pacientes em comparação com o uso da fórmula de Friedewald / Comparison of LDL-cholesterol direct measurement with the estimate using the Friedewald formula in a sample of 10, 664 patients

OBJETIVO: Avaliar a dosagem direta do colesterol LDL (LDL-C) por um método homogêneo, em comparação com a estimativa pela fórmula de Friedewald, em uma grande população heterogênea. MÉTODOS: As dosagens do colesterol total (ColT) e dos triglicerídeos (Trig) foram realizadas por métodos enzimáticos tradicionais. As dosagens do HDL-C e do LDL-C foram realizadas por métodos diretos, sem precipitação, e a estimativa da fração LDL-C calculada pela fórmula de Friedewald. RESULTADOS: Por análise de regressão linear, os dois métodos apresentaram coeficientes de correlação extremamente significativos (p<0,001). Entretanto, a fórmula de Friedewald apresentou um bias positivo em relação ao método direto, mais pronunciado com níveis de ColT > 201 mg/dL. Este bias positivo também ocorreu com relação a níveis de Trig < 150 mg/dL. Com níveis de Trig entre 151-200 mg/dL e entre 201-300 mg/dL, não foi observado bias entre os dois métodos. Por outro lado, com níveis de Trig entre 301-400 mg/dL, este bias da fórmula de Friedewald tornou-se negativo. CONCLUSÃO: Foi possível demonstrar que a fórmula de Friedewald não apresenta um desempenho homogêneo para a estimativa do LDL-C em amostras com diferentes níveis de Trig, em comparação com o método direto, podendo causar dúvidas na classificação quanto ao risco de desenvolver doença arterial coronariana.