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12th IFAC Symposium on Biological and Medical Systems (BMS)

作者： Ang, Christopher Yew Shuen Chiew, Yeong Shiong Wang, Xin Ooi, Ean Hin Nor, Mohd Basri Mat Zhou, Cong Chase, J. Geoffrey Monash Univ Malaysia Sch Engn Selangor Malaysia Int Islamic Univ Malaysia Kulliyah Med Kuantan 25200 Malaysia Univ Canterbury Ctr Bioengn Christchurch New Zealand

Pressure-controlled (PC) ventilation is a pressure-targeted mode of mechanical ventilation (MV) to prevent barotrauma by using pre-set driving pressures. However, the lack of clinician consensus on approaches towards pressure-targeted MV management can lead to suboptimal MV treatment and adverse patient outcomes. This study presents an in-silico trial for the validation of a pressure-based, stochastic model-integrated SiVENT protocol to guide this care. The PC SiVENT protocol uses a respiratory elastance (Ers) stochastic model and model-based methods to recommend a safe combination of MV input settings. The protocol was implemented on PC virtual patients (VP) (N=29;2,630 hours MV data) in a virtual trial to derive protocol-suggested MV settings and resulting VP responses to these MV settings. Virtual trial outcomes were compared with the retrospective clinical data and similar volume-control (VC) SiVENT virtual trials, by assessing the compliance rate of measured VP responses to established clinical safety thresholds. Out of 29 PC VPs, 3 retrospective VPs (similar to 10%) and 23 SiVENT VPs (similar to 79%) achieve an all compliance rate of > 80%. The results of the virtual trials demonstrate the efficacy of the SiVENT PC in regulating pressure-based MV outcomes, as well as the potential to safely streamline the development, optimisation and validation process of new MV decision support systems. The protocols presented would make measurable advances in individualised care with significant potential following improved patient outcomes in MV. The overall results justify prospective clinical trials. Copyright (C) 2024 The Authors. This is an open access article under the CC BY-NC-ND license (https://***/licenses/by-nc-nd/4.0/)

关键词： Mechanical Ventilation Pressure control Virtual Patient model-based protocols Virtual Trials

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Comparative Virtual Trials: Pressure-Controlled versus Volume-Controlled Stochastic Integrated model-based Mechanical Ventilation protocols

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IFAC-PapersOnLine 2024年第24期58卷 100-105页

作者： Christopher Yew Shuen Ang Yeong Shiong Chiew Xin Wang Ean Hin Ooi Mohd Basri Mat Nor Cong Zhou J. Geoffrey Chase School of Engineering Monash University Malaysia Selangor Malaysia Kulliyah of Medicine International Islamic University Malaysia Kuantan 25200 Malaysia Center of Bioengineering University of Canterbury Christchurch New Zealand

Pressure-controlled (PC) ventilation is a pressure-targeted mode of mechanical ventilation (MV) to prevent barotrauma by using pre-set driving pressures. However, the lack of clinician consensus on approaches towards pressure-targeted MV management can lead to suboptimal MV treatment and adverse patient outcomes. This study presents an in-silico trial for the validation of a pressure-based, stochastic model-integrated SiVENT protocol to guide this care. The PC SiVENT protocol uses a respiratory elastance (Ers) stochastic model and model-based methods to recommend a safe combination of MV input settings. The protocol was implemented on PC virtual patients (VP) (N=29; 2,630 hours MV data) in a virtual trial to derive protocol-suggested MV settings and resulting VP responses to these MV settings. Virtual trial outcomes were compared with the retrospective clinical data and similar volume-control (VC) SiVENT virtual trials, by assessing the compliance rate of measured VP responses to established clinical safety thresholds. Out of 29 PC VPs, 3 retrospective VPs (∼10%) and 23 SiVENT VPs (∼79%) achieve an all-compliance rate of > 80%. The results of the virtual trials demonstrate the efficacy of the SiVENT PC in regulating pressure-based MV outcomes, as well as the potential to safely streamline the development, optimisation and validation process of new MV decision support systems. The protocols presented would make measurable advances in individualised care with significant potential following improved patient outcomes in MV. The overall results justify prospective clinical trials.

关键词： Mechanical Ventilation Pressure control Virtual Patient model-based protocols Virtual Trials

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Virtual clinical trials for mechanically ventilated respiratory failure patients under volume-controlled ventilation - The Challenges of Volume-Control protocols 12

Virtual clinical trials for mechanically ventilated respirat...

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12th IFAC Symposium on Biological and Medical Systems (BMS)

Resource-intensive clinical trial is a crucial step in validating the safety and effectiveness of personalised, model-based mechanical ventilation (MV) treatments prior to implementation as a clinical standard of care. An alternative first step would be validated in-silico virtual patient (VP) trials. This study evaluates the efficacy of two model-based MV protocols (MBP) in regulating key pressure-based MV outcomes in volume-controlled MV using a well-established in-silico, virtual trial methodology. Two modified, closed-loop MBPs were implemented on volume-controlled VPs (N=18;955 hours MV data) to derive protocol-suggested MV settings and resulting VP responses to these MV settings. Virtual trial outcomes were compared between the two protocols, and with the retrospective clinical data, by assessing the adherence of measured VP responses to established clinical safety thresholds. A successful intervention is defined as an intervention interval during which the protocol successfully recommended a safe combination of MV settings, defined by established clinical safety thresholds. Both protocols performed 637 interventions with a success rate of 93.72%, improving the overall adherence of measured VP responses to established clinical safety thresholds by 53% compared to the retrospective clinical data. This virtual trial further validates the efficacy of VPs for long-term safety and performance assessments of MBPs. They also demonstrate the potential to safely streamline the development, optimisation and validation process of new MV decision support systems, as has been done in other areas of care. The overall outcomes could ultimately accelerate opportunities for the successful translation of these systems into clinical practice. Copyright (C) 2024 The Authors. This is an open access article under the CC BY-NC-ND license (https://***/licenses/by-nc-nd/4.0/)

关键词： Mechanical Ventilation Virtual Patient model-based protocols Virtual Trials

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Virtual clinical trials for mechanically ventilated respiratory failure patients under volume-controlled ventilation – The Challenges of Volume-Control protocols

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IFAC-PapersOnLine 2024年第24期58卷 94-99页

Resource-intensive clinical trial is a crucial step in validating the safety and effectiveness of personalised, model-based mechanical ventilation (MV) treatments prior to implementation as a clinical standard of care. An alternative first step would be validated in-silico virtual patient (VP) trials. This study evaluates the efficacy of two model-based MV protocols (MBP) in regulating key pressure-based MV outcomes in volume-controlled MV using a well-established in-silico, virtual trial methodology. Two modified, closed-loop MBPs were implemented on volume-controlled VPs (N=18; 955 hours MV data) to derive protocol-suggested MV settings and resulting VP responses to these MV settings. Virtual trial outcomes were compared between the two protocols, and with the retrospective clinical data, by assessing the adherence of measured VP responses to established clinical safety thresholds. A successful intervention is defined as an intervention interval during which the protocol successfully recommended a safe combination of MV settings, defined by established clinical safety thresholds. Both protocols performed 637 interventions with a success rate of 93.72%, improving the overall adherence of measured VP responses to established clinical safety thresholds by ∼53% compared to the retrospective clinical data. This virtual trial further validates the efficacy of VPs for long-term safety and performance assessments of MBPs. They also demonstrate the potential to safely streamline the development, optimisation and validation process of new MV decision support systems, as has been done in other areas of care. The overall outcomes could ultimately accelerate opportunities for the successful translation of these systems into clinical practice.

关键词： Mechanical Ventilation Virtual Patient model-based protocols Virtual Trials

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