Background The Covid-19 outbreak challenged health systems around the world to design and implement cost-effective devices to complement mechanical ventilators that can be produced locally. Masi works as a mechanical ventilator to bring life-support by automating a resucitation bag to closely control ventilatory parameters. Methods This pre-clinical trial was designed to study the physiological responses of healthy swine maintained under volume- or pressure-controlled mechanical ventilation. Thus, physiological parameters were measured in eight sedated animals (t0), prior to inducing deep anesthesia, as well as during the next six hours of mechanical ventilation with Masi (t1-7). Hemodynamic conditions were monitored periodically using a gas analyzer machine (i.e. BEecf, HCO3, SaO2, lactate, pH, PaO2, PaCO2) and a capnometer (i.e. ETCO2). Electrocardiogram, echocardiography and lung ultrasonography were performed to detect in vivo alterations in these vital organs and pathological findings from necropsy are reported. Results The mechanical ventilator properly controlled physiological levels of blood biochemistry such as oxygenation parameters (PaO2, PaCO2, SaO2, ETCO2), acid-base equilibrium (pH, HCO3−, BEecf), and perfusion of tissues (lactate levels). In addition, histopathological analysis showed no evidence of acute tissue damage in lung, heart, liver, kidney, or brain. Moreover, all animals were able to breathe spontaneously after undergoing mechanical ventilation controlled by Masi device. The results demonstrate that Masi mechanical ventilator allows the regulation of body gas exchange and maintain the physiological parameters in the normal range for swine. Conclusions These preclinical data, added to the appropriate performance of Masi in engineering laboratory tests, support the biological safety of the medical device to move forward to further evaluation in clinical studies.
La raza Perro Sin Pelo del Perú (PSPP) fue registrada en 1981 en la Federación Cinológica Internacional y es Patrimonio Nacional del país. La raza tiene definido tres tamaños: grande, mediano y pequeño. Se han publicado valores ecocardiográficos de referencia para la población canina en general; sin embargo, el valor clínico es relativo al considerar la variación existente entre las razas y sus categorías. El propósito de este estudio fue determinar los valores ecocardiográficos normales del PSPP según edad, peso y sexo. La muestra fue de 10 machos y 20 hembras; comprendiendo 17 adultos jóvenes, 9 adultos medios y 4 adultos avanzados, y por peso corporal en 15 canes ≥8 - ≤10 kg y 15 canes >10 - ≤12 kg. Se evaluaron 10 parámetros ecocardiográficos, los cuales no presentaron diferencias significativas por grupo etario. La variable peso mostró diferencias significativas para los valores DVID (diámetro ventricular izquierdo en diástole), DPVIS (diámetro del septo interventricular en sístole), DPVID (diámetro de la pared ventricular izquierda en diástole), DSVID (diámetro del septo interventricular en diástole) y DVDS (diámetro ventricular derecho en sístole), siendo mayor en el grupo más pesado (10-12 kg), en tanto que, la variable sexo mostró diferencias significativas para AI (diámetro del atrio izquierdo) y AI/AO (relación entre AI y el diámetro de la aorta), siendo mayor en los machos. Todos los valores ecocardiográficos para las tres variables estudiadas se encontraron dentro del rango esperado para la especie.
The Covid-19 outbreak challenged health systems around the world to design and implement cost-effective devices produced locally to meet the increased demand of mechanical ventilators worldwide. This study evaluates the physiological responses of healthy swine maintained under volume- or pressure-controlled mechanical ventilation by a mechanical ventilator implemented to bring life-support by automating a resuscitation bag and closely controlling ventilatory parameters. Physiological parameters were monitored in eight sedated animals (t0) prior to inducing deep anaesthesia, and during the next six hours of mechanical ventilation (t1-7). Hemodynamic conditions were monitored periodically using a portable gas analyser machine (i.e. BEecf, carbonate, SaO2, lactate, pH, PaO2, PaCO2) and a capnometer (i.e. ETCO2). Electrocardiogram, echocardiography and lung ultrasonography were performed to detect in vivo alterations in these vital organs and pathological findings from necropsy were reported. The mechanical ventilator properly controlled physiological levels of blood biochemistry such as oxygenation parameters (PaO2, PaCO2, SaO2, ETCO2), acid-base equilibrium (pH, carbonate, BEecf), and perfusion of tissues (lactate levels). In addition, histopathological analysis showed no evidence of acute tissue damage in lung, heart, liver, kidney, or brain. All animals were able to breathe spontaneously after undergoing mechanical ventilation. These preclinical data, supports the biological safety of the medical device to move forward to further evaluation in clinical studies.
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