Design assessment and preliminary performance evaluation of a novel device for non-invasive emergency treatment of acute respiratory failure.
- 1Department of Electronics, Information and Bioengineering, Politecnico Di Milano, Milan, Italy.
- 2Department of Anaesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
- 3Faculty of Medicine and Surgery, Vita-Salute San Raffaele University, Milan, Italy.
Abstract
Acute respiratory failure (ARF) requires rapid intervention to prevent patient deterioration and life-threatening complications. Early respiratory support through prehospital Continuous Positive Airway Pressure (CPAP) has been shown to improve ARF outcomes. However, existing CPAP devices present technical barriers for use in out-of-hospital emergency scenarios. This study presents the design and preliminary performance evaluation of a novel portable, ready-to-use CPAP device for out-of-hospital respiratory support. The device includes a blower providing steady air insufflation through a face mask, with Positive End-Expiratory Pressure (PEEP) regulated by two fixed-point PEEP valves. To identify optimized operational conditions ensuring target respiratory support, a lumped-parameter model (LPM) was developed to simulate device-patient interaction. Input data for the LPM included experimental characteristics of the device components. Simulations were conducted using breathing profiles representing varying ARF-like conditions and severity. Additionally, computational fluid dynamics (CFD) analysis was performed to assess the risk of CO2 rebreathing through the mask. LPM simulations described the dynamic interaction between the breathing profile and device performances, and the consequent pressure and flow patterns during the respiratory cycle. Across all simulated conditions and device settings, PEEP remained close to the predefined target of 5 cm H2O without reaching critical thresholds, confirming design choices efficacy. CFD analysis indicated an end-expiratory residual CO2 concentration of ~2%, suggesting a low risk of rebreathing between cycles. Our results confirmed the validity of our design solutions and suggest a potentially safe and efficient profile as a promising solution for early CPAP use in emergency settings. The online version contains supplementary material available at https://doi.org/10.1007/s13534-026-00619-3.
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BibTeX
@article{negri2026design,
title = {{Design assessment and preliminary performance evaluation of a novel device for non-invasive emergency treatment of acute respiratory failure.}},
author = {Federica Ciceri Negri and Eleonora Salurso and Giuseppe Giardina and Filippo Consolo and Giovanni Landoni and Alberto Cesare Luigi Redaelli and Gianfranco Beniamino Fiore},
journal = {Biomedical engineering letters},
year = {2026},
month = oct,
doi = {10.1007/s13534-026-00619-3},
url = {https://europepmc.org/article/MED/42996539},
note = {CC BY},
}
RIS
TY - JOUR
TI - Design assessment and preliminary performance evaluation of a novel device for non-invasive emergency treatment of acute respiratory failure.
AU - Federica Ciceri Negri
AU - Eleonora Salurso
AU - Giuseppe Giardina
AU - Filippo Consolo
AU - Giovanni Landoni
AU - Alberto Cesare Luigi Redaelli
AU - Gianfranco Beniamino Fiore
PY - 2026
DA - 2026/10/25
JO - Biomedical engineering letters
DO - 10.1007/s13534-026-00619-3
UR - https://europepmc.org/article/MED/42996539
AB - Acute respiratory failure (ARF) requires rapid intervention to prevent patient deterioration and life-threatening complications. Early respiratory support through prehospital Continuous Positive Airway Pressure (CPAP) has been shown to improve ARF outcomes. However, existing CPAP devices present technical barriers for use in out-of-hospital emergency scenarios. This study presents the design and preliminary performance evaluation of a novel portable, ready-to-use CPAP device for out-of-hospital respiratory support. The device includes a blower providing steady air insufflation through a face mask, with Positive End-Expiratory Pressure (PEEP) regulated by two fixed-point PEEP valves. To identify optimized operational conditions ensuring target respiratory support, a lumped-parameter model (LPM) was developed to simulate device-patient interaction. Input data for the LPM included experimental characteristics of the device components. Simulations were conducted using breathing profiles representing varying ARF-like conditions and severity. Additionally, computational fluid dynamics (CFD) analysis was performed to assess the risk of CO2 rebreathing through the mask. LPM simulations described the dynamic interaction between the breathing profile and device performances, and the consequent pressure and flow patterns during the respiratory cycle. Across all simulated conditions and device settings, PEEP remained close to the predefined target of 5 cm H2O without reaching critical thresholds, confirming design choices efficacy. CFD analysis indicated an end-expiratory residual CO2 concentration of ~2%, suggesting a low risk of rebreathing between cycles. Our results confirmed the validity of our design solutions and suggest a potentially safe and efficient profile as a promising solution for early CPAP use in emergency settings. The online version contains supplementary material available at https://doi.org/10.1007/s13534-026-00619-3.
SN - 2093-9868
SN - 2093-985X
ER -