TY - JOUR
T1 - The development and implementation of a low-cost mechanical ventilator in a low-middle-income country during the COVID-19 pandemic
T2 - The Unisabana-HERONS
AU - Giraldo-Cadavid, Luis Fernando
AU - Echeverry, Julian
AU - Varón-Vega, Fabio
AU - Bastidas, Alirio
AU - Ramírez-Jaime, Andrés
AU - Cardona, Andrés Felipe
AU - Lopez Vega, Cristian Joao
AU - Serrano-Mayorca, Cristian C.
AU - Garay, Diana
AU - Rincón, Diego Nicolás
AU - Oliveros, Henry
AU - Ramírez, Iván Arturo
AU - Garcia-Gallo, Esteban
AU - Enciso-Prieto, Valeria A.
AU - Ibáñez-Prada, Elsa D.
AU - Camelo, Juan Carlos
AU - Cucunubo, Laura
AU - Buitrago, Lina
AU - Paipa, Luis Alfredo
AU - Longas, Luis Carlos
AU - Agudelo-Otálora, Luis Mauricio
AU - Porras Diaz, Nestor Fernando
AU - Rachid, Rolando Roncancio
AU - Henao I, Rubén Darío
AU - Pedraza, Santiago
AU - Reyes, Luis Felipe
N1 - Funding Information:
To validate the safety and effectiveness of the Unisabana-HERONS in humans, a prospective cohort was recruited at Cl\u00EDnica Universidad de La Sabana. Eligibility criteria: patients who required UCI admission and were under mechanical ventilatory support on volume control mode with an expected duration greater than 24 h between July 1, 2020, and August 20, 2020, were included. Patients must have also fulfilled any of the following inclusion criteria [1]: Acute respiratory failure (PaO2/FiO2 <300) requiring mechanical ventilation [2], postoperative requiring ventilatory support [3], head trauma with the indication of mechanical ventilatory support [4], acute intoxication and respiratory depression with an indication of mechanical ventilatory supply.This study was funded by Universidad de La Sabana under the grant MED-328-2022.The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Luis Fernando Giraldo-Cadavid reports administrative support, equipment, drugs, or supplies, statistical analysis, and writing assistance were provided by Universidad de La Sabana.The investigators of this study acknowledge the Universidad de La Sabana for supporting and leading this project during challenging times in the country.
Funding Information:
This study was funded by Universidad de La Sabana under the grant MED-328-2022.
Publisher Copyright:
© 2024
PY - 2024/5/15
Y1 - 2024/5/15
N2 - 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.
AB - 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.
KW - COVID-19
KW - Invasive mechanical ventilator
KW - Respiratory failure
UR - https://www.scopus.com/pages/publications/85192246441
U2 - 10.1016/j.heliyon.2024.e30671
DO - 10.1016/j.heliyon.2024.e30671
M3 - Article
C2 - 38756610
AN - SCOPUS:85192246441
SN - 2405-8440
VL - 10
JO - Heliyon
JF - Heliyon
IS - 9
M1 - e30671
ER -