Academic Journal
The development and implementation of a low-cost mechanical ventilator in a low-middle-income country during the COVID-19 pandemic: The Unisabana-HERONS
| Title: | The development and implementation of a low-cost mechanical ventilator in a low-middle-income country during the COVID-19 pandemic: The Unisabana-HERONS |
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| Authors: | Luis Fernando Giraldo-Cadavid, Julian Echeverry, Fabio Varón-Vega, Alirio Bastidas, Andrés Ramírez-Jaime, Andrés Felipe Cardona, Cristian Joao Lopez Vega, Cristian C. Serrano-Mayorca, Diana Garay, Diego Nicolás Rincón, Henry Oliveros, Iván Arturo Ramírez, Esteban Garcia-Gallo, Valeria A. Enciso-Prieto, Elsa D. Ibáñez-Prada, Juan Carlos Camelo, Laura Cucunubo, Lina Buitrago, Luis Alfredo Paipa, Luis Carlos Longas, Luis Mauricio Agudelo-Otálora, Nestor Fernando Porras Diaz, Rolando Roncancio Rachid, Rubén Darío Henao I, Santiago Pedraza, Luis Felipe Reyes |
| Source: | Heliyon, Vol 10, Iss 9, Pp e30671- (2024) |
| Publisher Information: | Elsevier, 2024. |
| Publication Year: | 2024 |
| Collection: | LCC:Science (General) LCC:Social sciences (General) |
| Subject Terms: | COVID-19, Invasive mechanical ventilator, Respiratory failure, Science (General), Q1-390, Social sciences (General), H1-99 |
| More Details: | 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. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 2405-8440 |
| Relation: | http://www.sciencedirect.com/science/article/pii/S2405844024067021; https://doaj.org/toc/2405-8440 |
| DOI: | 10.1016/j.heliyon.2024.e30671 |
| Access URL: | https://doaj.org/article/cfde260dc1f543f793d2e1fef29e1486 |
| Accession Number: | edsdoj.fde260dc1f543f793d2e1fef29e1486 |
| Database: | Directory of Open Access Journals |
| ISSN: | 24058440 |
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| DOI: | 10.1016/j.heliyon.2024.e30671 |
| Published in: | Heliyon |
| Language: | English |