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.

Major adverse cardiovascular events (MACE) in patients with severe COVID-19 registered in the ISARIC WHO clinical characterization protocol: A prospective, multinational, observational study.

PURPOSE: To determine its cumulative incidence, identify the risk factors associated with Major Adverse Cardiovascular Events (MACE) development, and its impact clinical outcomes. MATERIALS AND METHODS: This multinational, multicentre, prospective cohort study from the ISARIC database. We used bivariate and multivariate logistic regressions to explore the risk factors related to MACE development and determine its impact on 28-day and 90-day mortality. RESULTS: 49,479 patients were included. Most were male 63.5% (31,441/49,479) and from high-income countries (84.4% [42,774/49,479]); however, >6000 patients were registered in low-and-middle-income countries. MACE cumulative incidence during their hospital stay was 17.8% (8829/49,479). The main risk factors independently associated with the development of MACE were older age, chronic kidney disease or cardiovascular disease, smoking history, and requirement of vasopressors or invasive mechanical ventilation at admission. The overall 28-day and 90-day mortality were higher among patients who developed MACE than those who did not (63.1% [5573/8829] vs. 35.6% [14,487/40,650] p < 0.001; 69.9% [6169/8829] vs. 37.8% [15,372/40,650] p < 0.001, respectively). After adjusting for confounders, MACE remained independently associated with higher 28-day and 90-day mortality (Odds Ratio [95% CI], 1.36 [1.33-1.39];1.47 [1.43-1.50], respectively). CONCLUSIONS: Patients with severe COVID-19 frequently develop MACE, which is independently associated with worse clinical outcomes.

Índice de Oxigenação Respiratória prevê falha de pós-extubação com cânula nasal de alto fluxo em pacientes de unidade de terapia intensiva: estudo de coorte retrospectivo / The Respiratory Rate-Oxygenation Index predicts failure of post-extubation high-flow nasal cannula therapy in intensive care unit patients: a retrospective cohort study

RESUMO Objetivo: Investigar a aplicabilidade do Índice de Oxigenação Respiratória para identificar o risco de falha de cânula nasal de alto fluxo em pacientes com pneumonia. Métodos: Este estudo retrospectivo observacional de 2 anos foi realizado em um hospital de referência em Bogotá, na Colômbia. Incluíram-se no estudo todos os pacientes em que foi utilizada cânula nasal de alto fluxo pós-extubação como terapia-ponte para a extubação. O Índice de Oxigenação Respiratória foi calculado para avaliar o risco de falha pós-extubação de cânula nasal de alto fluxo. Resultados: Incluíram-se no estudo 162 pacientes. Destes, 23,5% apresentaram falha de cânula nasal de alto fluxo. O Índice de Oxigenação Respiratória foi significativamente menor em pacientes que tiveram falha de cânula nasal de alto fluxo. A mediana (IQ 25 - 75%) foi de 10,0 (7,7 - 14,4) versus 12,6 (10,1 - 15,6), com p = 0,006. O Índice de Oxigenação Respiratória > 4,88 apresentou razão de chances bruta de 0,23 (IC95% 0,17 - 0,30) e RC ajustada de 0,89 (IC95% 0,81 - 0,98) estratificada por gravidade e comorbidade. Após a análise de regressão logística, o Índice de Oxigenação Respiratória apresentou razão de chances ajustada de 0,90 (IC95% 0,82 - 0,98; p = 0,026). A área sob a curva Receiver Operating Characteristic para falha de extubação foi de 0,64 (IC95% 0,53 - 0,75; p = 0,06). O Índice de Oxigenação Respiratória não apresentou diferenças entre pacientes que sobreviveram e que morreram durante internação na unidade de terapia intensiva. Conclusão: O Índice de Oxigenação Respiratória é uma ferramenta acessível para identificar pacientes em risco de falha no tratamento pós-extubação com cânulas nasais de alto fluxo. Estudos prospectivos são necessários para ampliar a utilidade nesse cenário.

ABSTRACT Objective: To investigate the applicability of the Respiratory Rate-Oxygenation Index to identify the risk of high-flow nasal cannula failure in post-extubation pneumonia patients. Methods: This was a 2-year retrospective observational study conducted in a reference hospital in Bogotá, Colombia. All patients in whom post-extubation high-flow nasal cannula therapy was used as a bridge to extubation were included in the study. The Respiratory Rate-Oxygenation Index was calculated to assess the risk of post-extubation high-flow nasal cannula failure. Results: A total of 162 patients were included in the study. Of these, 23.5% developed high-flow nasal cannula failure. The Respiratory Rate-Oxygenation Index was significantly lower in patients who had high-flow nasal cannula failure [median (IQR): 10.0 (7.7 - 14.4) versus 12.6 (10.1 - 15.6); p = 0.006]. Respiratory Rate-Oxygenation Index > 4.88 showed a crude OR of 0.23 (95%CI 0.17 - 0.30) and an adjusted OR of 0.89 (95%CI 0.81 - 0.98) stratified by severity and comorbidity. After logistic regression analysis, the Respiratory Rate-Oxygenation Index had an adjusted OR of 0.90 (95%CI 0.82 - 0.98; p = 0.026). The area under the Receiver Operating Characteristic curve for extubation failure was 0.64 (95%CI 0.53 - 0.75; p = 0.06). The Respiratory Rate-Oxygenation Index did not show differences between patients who survived and those who died during the intensive care unit stay. Conclusion: The Respiratory Rate-Oxygenation Index is an accessible tool to identify patients at risk of failing high-flow nasal cannula post-extubation treatment. Prospective studies are needed to broaden the utility in this scenario.