Rodriguez Noe, Rubio Carlos, Barriga Leonardo, Fonseca Fernando, Soto Jorge, Pineda Jose, Sanchez David, Rojas Antonio, Lopez David, Madrigal Dalia, Villagran Blanca, Sosa Mayra, Ñamendys Silvio, Gutierrez Alan, Cueto Alain
Center for Engineering and Industrial Development, Queretaro, Mexico.
University Center for Agricultural Biological Sciences, University of Guadalajara, Jalisco, Mexico.
J Invest Surg. 2025 Dec;38(1):2534857. doi: 10.1080/08941939.2025.2534857. Epub 2025 Jul 24.
Researchers proposed mechanical ventilators (MVs) based on the automated compression of a self-inflating bag (SIB) to save lives during the pandemic caused by the SARS-CoV-2 virus. Many proposals had problems with continuous use time, repeatability of ventilatory variables, high partial pressure of carbon dioxide (PaCO) values, and a decreasing fraction of inspired oxygen (FiO) for high respiratory rates.
This study aimed to demonstrate that our technology, based on automated compression of an SIB, can operate for several days, is repeatable in its ventilatory variables, and is safe in the ventilator-patient interaction.
Ehecatl-4T (EHT) MV was based on SIB. We first validated the repeatability of the ventilatory variables using a lung simulator for different compliances (0.01 up to 0.05 L/cmHO) and resistances (5 up to 50 cmHO·s/L). Subsequently, we conducted a long-term durability test to maintain the ventilatory parameters. Finally, the EHT was tested in a preclinical study using 12 York-Landrace × Pietrain-Duroc pigs weighing 87 ± 5 kg. Six pigs were assigned to the experimental group and six were assigned to the reference group.
The EHT presented a relative error within the allowed margin for both pressure and volume modes. The EHT was operated for over 32 days without affecting the ventilatory variables. In the preclinical study, the PaCO and FiO values were close to the reference levels.
The EHT showed potential for continuous use, demonstrating repeatability for ventilatory variables in bench testing. Clinical parameters were maintained according to the industry safety standards.
研究人员提出了基于自动挤压自充气袋（SIB）的机械通气机（MV），以在由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）病毒引起的大流行期间挽救生命。许多提议在连续使用时间、通气变量的可重复性、高二氧化碳分压（PaCO）值以及高呼吸频率下吸入氧分数（FiO）降低等方面存在问题。
本研究旨在证明我们基于自动挤压SIB的技术能够运行数天，通气变量具有可重复性，并且在通气机与患者的相互作用中是安全的。
Ehecatl-4T（EHT）MV基于SIB。我们首先使用肺模拟器针对不同的顺应性（0.01至0.05 L/cmH₂O）和阻力（5至50 cmH₂O·s/L）验证通气变量的可重复性。随后，我们进行了长期耐久性测试以维持通气参数。最后，在一项临床前研究中，使用12头体重为87±5 kg的约克-长白×皮特兰-杜洛克猪对EHT进行测试。6头猪被分配到实验组，6头被分配到参考组。
EHT在压力和容积模式下的相对误差均在允许范围内。EHT运行超过32天，且未影响通气变量。在临床前研究中，PaCO和FiO值接近参考水平。
EHT显示出连续使用的潜力，在台架测试中证明了通气变量的可重复性。临床参数符合行业安全标准。
