Toward a Self-Inflating Bag Mechanical Ventilator, Maturation in Continuous Use, Safety, and Repeatability for Ventilatory Variables.

IF 2.1 4区 医学 Q2 SURGERY
Journal of Investigative Surgery Pub Date : 2025-12-01 Epub Date: 2025-07-24 DOI:10.1080/08941939.2025.2534857
Noe Rodriguez, Carlos Rubio, Leonardo Barriga, Fernando Fonseca, Jorge Soto, Jose Pineda, David Sanchez, Antonio Rojas, David Lopez, Dalia Madrigal, Blanca Villagran, Mayra Sosa, Silvio Ñamendys, Alan Gutierrez, Alain Cueto
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引用次数: 0

Abstract

Background: 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 (PaCO2) values, and a decreasing fraction of inspired oxygen (FiO2) for high respiratory rates.

Objective: 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.

Materials and methods: 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/cmH2O) and resistances (5 up to 50 cmH2O·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.

Results: 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 PaCO2 and FiO2 values were close to the reference levels.

Conclusion: 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.

自动充气袋式机械呼吸机:连续使用的成熟、安全性和呼吸变量的可重复性。
背景:研究人员提出了基于自动压缩自充气袋(SIB)的机械呼吸机(MVs),以挽救SARS-CoV-2病毒大流行期间的生命。许多建议存在连续使用时间、通气变量的可重复性、高二氧化碳分压(PaCO2)值以及高呼吸速率时吸入氧(FiO2)分数下降的问题。目的:本研究旨在证明我们的基于SIB自动压缩的技术可以运行数天,其通气变量是可重复的,并且在呼吸机与患者的相互作用中是安全的。材料与方法:Ehecatl-4T (EHT) MV以SIB为基础。我们首先使用肺模拟器验证了不同顺应性(0.01至0.05 L/cmH2O)和阻力(5至50 cmH2O·s/L)的通气变量的可重复性。随后,我们进行了长期耐久性测试,以维持通风参数。最后,在临床前研究中对12头体重为87±5 kg的约克-长白×皮特-杜洛克猪进行EHT测试。6头猪分为试验组,6头猪分为对照组。结果:EHT在压力模式和体积模式下均存在相对误差。EHT手术超过32天,未影响通气指标。在临床前研究中,PaCO2和FiO2值接近参考水平。结论:EHT具有连续使用的潜力,在台架试验中展示了通气变量的可重复性。临床参数按照行业安全标准进行维护。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.20
自引率
0.00%
发文量
114
审稿时长
6-12 weeks
期刊介绍: Journal of Investigative Surgery publishes peer-reviewed scientific articles for the advancement of surgery, to the ultimate benefit of patient care and rehabilitation. It is the only journal that encompasses the individual and collaborative efforts of scientists in human and veterinary medicine, dentistry, basic and applied sciences, engineering, and law and ethics. The journal is dedicated to the publication of outstanding articles of interest to the surgical research community.
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