Efficacy and Safety of Tinzaparin in Prophylactic, Intermediate and Therapeutic Doses in Non-Critically Ill Patients Hospitalized with COVID-19: The PROTHROMCOVID Randomized Controlled Trial.

Hospitalized patients with COVID-19 are at increased risk of thrombosis, acute respiratory distress syndrome and death. The optimal dosage of thromboprophylaxis is unknown. The aim was to evaluate the efficacy and safety of tinzaparin in prophylactic, intermediate, and therapeutic doses in non-critical patients admitted for COVID-19 pneumonia. PROTHROMCOVID is a randomized, unblinded, controlled, multicenter trial enrolling non-critical, hospitalized adult patients with COVID-19 pneumonia. Patients were randomized to prophylactic (4500 IU), intermediate (100 IU/kg), or therapeutic (175 IU/kg) groups. All tinzaparin doses were administered once daily during hospitalization, followed by 7 days of prophylactic tinzaparin at discharge. The primary efficacy outcome was a composite endpoint of symptomatic systemic thrombotic events, need for invasive or non-invasive mechanical ventilation, or death within 30 days. The main safety outcome was major bleeding at 30 days. Of the 311 subjects randomized, 300 were included in the prespecified interim analysis (mean [SD] age, 56.7 [14.6] years; males, 182 [60.7%]). The composite endpoint at 30 days from randomization occurred in 58 patients (19.3%) of the total population; 19 (17.1 %) in the prophylactic group, 20 (22.1%) in the intermediate group, and 19 (18.5%) in the therapeutic dose group (p = 0.72). No major bleeding event was reported; non-major bleeding was observed in 3.7% of patients, with no intergroup differences. Due to these results and the futility analysis, the trial was stopped. In non-critically ill COVID-19 patients, intermediate or full-dose tinzaparin compared to standard prophylactic doses did not appear to affect the risk of thrombotic event, non-invasive ventilation, or mechanical ventilation or death. Trial RegistrationClinicalTrials.gov Identifier (NCT04730856). Edura-CT registration number: 2020-004279-42.

The Impact of Different Lung Ultrasound Protocols in the Assessment of Lung Lesions in COVID-19 Patients: Is There an Ideal Lung Ultrasound Protocol?

BACKGROUND: In the past months, several lung ultrasonography (LUS) protocols have been proposed, mainly on previously validated schemes independent of coronavirus disease 2019 (COVID-19). OBJECTIVES: The main purpose of this study was to determine the impact and accuracy of different LUS protocols proposed in COVID-19. METHODS: Patients were evaluated with a standard sequence of LUS scans in 72 intercostal spaces along 14 anatomic lines in the chest. A scoring system of LUS findings was reported and then analyzed separately according to each proposed LUS protocol zones. This score was then correlated to a validated Pulmonary Inflammation Index (PII) on chest Computed Tomography (CT). RESULTS: Thirty-two patients were enrolled. The most frequent pattern was ground-glass opacities in the chest X-ray (53.1%), chest CT (59.1%) and subpleural or lobar consolidations (40.8%) in the posteroinferior areas (p < 0.001) on LUS. The Interclass Correlation Coefficient (ICC) was significantly correlated with almost every protocol analyzed except the 8-zone (p = 0.119) and the 10-zone protocol that only included one posterior point (p = 0.052). The highest ICC was obtained with a 12-zone protocol (ICC 0.500; p = 0.027) and decreased as more points were included. CONCLUSIONS: In conclusion, our study results suggest that performing an ultrasound protocol with 12-zone scanning, including the superior and inferior areas of the anterior, lateral and posterior regions of the chest was consistent with higher ICC and higher degree of concordance with CT. We emphasize the need of a more standardization technique to further implement and develop this imaging modality in COVID-19.

Evaluación de dos métodos de canalización vascular con ayuda ecográfica en operadores sin experiencia previa / Ultrasound-guided venous cannulation by inexperienced residents: comparison of 2 methods

Objetivos: Comparar los resultados de la canalización venosa con guía ecográfica tanto en el método tradicional como con la ayuda de un sistema de guía para la aguja en una población de operadores sin experiencia. Método: Estudio experimental realizado en una población de 32 médicos residentes voluntarios que realizaron intentos respectivos de canalización convencional y con sistema de guía de la aguja sobre un simulador de acceso venoso central. Se midieron el número de intentos y el tiempo en realizar la canalización. Resultados: El sistema de aguja-guía obtuvo un tiempo medio hasta canalización de 16,22 segundos frente a los29,93 de la técnica convencional (p = 0,045). El número de intentos del sistema aguja-guía fue de 1,09 frente a los1,88 del sistema convencional (p = 0,001). Subjetivamente el 59,4% de los operadores manifestaron que la técnica de aguja-guía es más fácil de utilizar, frente al 25% de los que opinaban que era más fácil la técnica tradicional y el15,6% que opinaban que presentaban una dificultad similar. Conclusiones: En esta muestra de operadores sin experiencia previa en la utilización de la ecografía ni de la guía ecográfica, el uso de un sistema de guía para la aguja disminuye significativamente el número de intentos y el tiempo que se tarda en conseguir la canalización del vaso. Además, la percepción subjetiva del operador indica que es una técnica más fácil de realizar (AU)

Objectives: To compare venous catheter insertion by inexperienced medical residents using a traditional ultrasound guidance method and ultrasound with a probe to guide the needle. Methods: Experimental study in which a group of 32 medical resident volunteers attempted to established a venous access in a simulator using ultrasound guidance with and without addition of a bracket device to guide insertion of the needle. We recorded the number of attempts and the time required to insert the catheter. Results: Catheterization took an average of 16.22 seconds with the device and 29.93 without it (P = .045). Fewer attempts were required with the needle guidance device (mean, 1.09 attempts vs 1.88 with the conventional method; P = .001). The subjective assessment of 59.4% of the residents was that the procedure with the guide bracket was easier; however, 25%felt the conventional method was, easier and 15.6% reported a similar level of difficulty with both methods. Conclusions: In this group of residents without prior experience of venous cannulation or ultrasound guidance, significantly fewer attempts were required and the catheter was correctly inserted sooner when the needle guide was used. Furthermore, most residents felt insertion was easier when the guide was used (AU)

[Ultrasound-guided venous cannulation by inexperienced residents: comparison of 2 methods]. / Evaluación de dos métodos de canalización vascular con ayuda ecográfica en operadores sin experiencia previa.

OBJECTIVES: To compare venous catheter insertion by inexperienced medical residents using a traditional ultrasound guidance method and ultrasound with a probe to guide the needle. MATERIAL AND METHODS: Experimental study in which a group of 32 medical resident volunteers attempted to established a venous access in a simulator using ultrasound guidance with and without addition of a bracket device to guide insertion of the needle. We recorded the number of attempts and the time required to insert the catheter. RESULTS: Catheterization took an average of 16.22 seconds with the device and 29.93 without it (P = .045). Fewer attempts were required with the needle guidance device (mean, 1.09 attempts vs 1.88 with the conventional method; P = .001). The subjective assessment of 59.4% of the residents was that the procedure with the guide bracket was easier; however, 25% felt the conventional method was, easier and 15.6% reported a similar level of difficulty with both methods. CONCLUSION: In this group of residents without prior experience of venous cannulation or ultrasound guidance, significantly fewer attempts were required and the catheter was correctly inserted sooner when the needle guide was used. Furthermore, most residents felt insertion was easier when the guide was used.

OBJETIVO: Comparar los resultados de la canalización venosa con guía ecográfica tanto en el método tradicional como con la ayuda de un sistema de guía para la aguja en una población de operadores sin experiencia. METODO: Estudio experimental realizado en una población de 32 médicos residentes voluntarios que realizaron intentos respectivos de canalización convencional y con sistema de guía de la aguja sobre un simulador de acceso venoso central. Se midieron el número de intentos y el tiempo en realizar la canalización. RESULTADOS: El sistema de aguja-guía obtuvo un tiempo medio hasta canalización de 16,22 segundos frente a los 29,93 de la técnica convencional (p = 0,045). El número de intentos del sistema aguja-guía fue de 1,09 frente a los 1,88 del sistema convencional (p = 0,001). Subjetivamente el 59,4% de los operadores manifestaron que la técnica de aguja-guía es más fácil de utilizar, frente al 25% de los que opinaban que era más fácil la técnica tradicional y el 15,6% que opinaban que presentaban una dificultad similar. CONCLUSIONES: En esta muestra de operadores sin experiencia previa en la utilización de la ecografía ni de la guía ecográfica, el uso de un sistema de guía para la aguja disminuye significativamente el número de intentos y el tiempo que se tarda en conseguir la canalización del vaso. Además, la percepción subjetiva del operador indica que es una técnica más fácil de realizar.