Periodic Reporting for period 2 - VASCOVID (PORTABLE PLATFORM FOR THE ASSESSMENT OF MICROVASCULAR HEALTH IN COVID-19 PATIENTS AT THE INTENSIVE CARE)
Periodo di rendicontazione: 2021-12-01 al 2023-05-31
At the time of the conception of the project, the COVID-19 pandemic was spreading rapidly causing havoc in the healthcare systems worldwide. In fact, as COVID-19 spread worldwide, the surge in patients requiring intensive care unit (ICU) admission overwhelmed the healthcare systems with each wave. Critical care triage to allow the rationing of scarce ICU resources were needed but was and is still hindered due to lack of personalization. At that time, the management of acute respiratory failure and hemodynamics was critical at the ICU to deal with the flood of ICU patients with COVID-19 with an overwhelming number of patients requiring ICU care and mechanical ventilation. This formed the primary target of VASCOVID at its conception where we have focused on developing a unique tool to enable; the patient stratification derived from endothelial function evaluation, and, the evaluation of cardiopulmonary interactions that personalizes conservative ventilation strategies in order to avoid ventilator-induced lung injury and readiness to wean from the ventilator.
In particular, VASCOVID promised to deploy and mature our portable, non-invasive and real-time health monitoring platform for this purpose. This platform combined two bio-photonics technologies, time-resolved near-infrared spectroscopy and diffuse correlation spectroscopy, and is the fruit of long-term collaboration between core project partners in two European projects (BabyLux and LUCA) where high technology readiness level has been achieved for neuro-monitoring and thyroid cancer screening.
As well known, the number of COVID-19 patients, especially those requiring ICU stays has gone down drastically after the successful vaccination campaigns. We have predicted this and we have devised this platform to be useful in a broader range of ICU patients, potentially impacting patient care at many levels and under many protocols. VASCOVID has adapted and enriched the earlier multi-modal platforms to meet the needs of a typical ICU for patients requiring mechanical ventilation, as well as to leverage large-scale testing of new treatment procedures and therapies aimed to address microvascular impairment and to reduce extubation failure on ICU patients weaning out of mechanical ventilation life-support. The platform has grown to be a unique platform that is easy to deploy and is cost-effective. It provides real-time fast results and is integrated into a machine-learning/artificial intelligence infrastructure for adoption of such strategies to deal with this multi-modal data.
During the project, the platform was tested thoroughly at the ICU by end-users (clinicians/ICU professionals) under different protocols. It has also been tested for standardization and automatization of the protocols through different in vivo protocols. As we learned from the use of the system and from new literature, we have introduced new pilot studies and tested the platform for use in other areas such as post-ICU personalized physiotherapy when dealing with the effects of ICU acquired weakness, for management of fluid resuscitation and for estimation of new biomarkers. Throughout the project regulatory aspects were kept of utmost importance and the project resulted in definition of procedures, needs and initial documentation for its transition to clinical practice by pushing the readiness for CE certification forward.
In particular, VASCOVID promised to deploy and mature our portable, non-invasive and real-time health monitoring platform for this purpose. This platform combined two bio-photonics technologies, time-resolved near-infrared spectroscopy and diffuse correlation spectroscopy, and is the fruit of long-term collaboration between core project partners in two European projects (BabyLux and LUCA) where high technology readiness level has been achieved for neuro-monitoring and thyroid cancer screening.
As well known, the number of COVID-19 patients, especially those requiring ICU stays has gone down drastically after the successful vaccination campaigns. We have predicted this and we have devised this platform to be useful in a broader range of ICU patients, potentially impacting patient care at many levels and under many protocols. VASCOVID has adapted and enriched the earlier multi-modal platforms to meet the needs of a typical ICU for patients requiring mechanical ventilation, as well as to leverage large-scale testing of new treatment procedures and therapies aimed to address microvascular impairment and to reduce extubation failure on ICU patients weaning out of mechanical ventilation life-support. The platform has grown to be a unique platform that is easy to deploy and is cost-effective. It provides real-time fast results and is integrated into a machine-learning/artificial intelligence infrastructure for adoption of such strategies to deal with this multi-modal data.
During the project, the platform was tested thoroughly at the ICU by end-users (clinicians/ICU professionals) under different protocols. It has also been tested for standardization and automatization of the protocols through different in vivo protocols. As we learned from the use of the system and from new literature, we have introduced new pilot studies and tested the platform for use in other areas such as post-ICU personalized physiotherapy when dealing with the effects of ICU acquired weakness, for management of fluid resuscitation and for estimation of new biomarkers. Throughout the project regulatory aspects were kept of utmost importance and the project resulted in definition of procedures, needs and initial documentation for its transition to clinical practice by pushing the readiness for CE certification forward.
The first year of the VASCOVID project saw the development of the first clinical prototype that was to be tested that the intensive care unit (ICU). This prototype was used to evaluate endothelial and microvascular function in the ICU and on different protocols used on healthy volunteers. In other words, it was used to evaluate how well oxygen is reaching different organs of the body and whether the patient is at a higher risk of developing further complications due to the failure of these mechanisms. A part from the development of this prototype and testing as core goals, we have completed the plans for commercial system, took important steps towards regulatory approval readiness, explored different areas of applications and devices new protocols for study, clinical trials. Finally, we have also obtained additional funding to prepare research replicas.
These achievements were carried along with multitude of other activities where we have shown that the industrial partners do have the capabilities to operate in the market, we have incorporated a newly founded start-up company which has commercialized a module from one of the academic partners, we have reached out to the public as well as the end-users and explained these technologies and we have continued to broaden the scope of potential applications to achieve the highest impact on patient care.
The main results apart from the critical contributions related to the prototype development and exploitation have shown that the platform is a robust one that provides unique biomarkers of tissue hemodynamics and oxygen metabolism in real-time, non-invasively and continuously. Studies on more than two hundred patients and healthy volunteers have allowed us to train ten end-users to operate the system, to standardize the protocols, specially pertaining to the vascular occlusion test, to evaluate the limits of accuracy and precision of the system and to derive new biomarkers of metabolism and microvascular health.
These achievements were carried along with multitude of other activities where we have shown that the industrial partners do have the capabilities to operate in the market, we have incorporated a newly founded start-up company which has commercialized a module from one of the academic partners, we have reached out to the public as well as the end-users and explained these technologies and we have continued to broaden the scope of potential applications to achieve the highest impact on patient care.
The main results apart from the critical contributions related to the prototype development and exploitation have shown that the platform is a robust one that provides unique biomarkers of tissue hemodynamics and oxygen metabolism in real-time, non-invasively and continuously. Studies on more than two hundred patients and healthy volunteers have allowed us to train ten end-users to operate the system, to standardize the protocols, specially pertaining to the vascular occlusion test, to evaluate the limits of accuracy and precision of the system and to derive new biomarkers of metabolism and microvascular health.
VASCOVID has already pushed the state-of-the-art beyond where it was in both technology development and in clinical/physiological knowledge. The new prototype includes aspects that do not exist in the market and even in the research field. It has incorporated new modules; a smart-probe with safety and data acquisition features, a fully automated smart tourniquet, a unique wireless remote access/control module, a built-in infrastructure for machine-learning and the combination of the state-of-the-art optical modalities. Our validation of the potential impact depends on the current studies and the future clinical trials – clinical trials were not allowed in this call. If successfully demonstrated in clinical trials, we believe the reduction of patient morbidity and the associated socio-economic cost would be immense covering populations ranging from the critically ill newborn to the general ICU patients to the elderly. We have carried a detailed analysis of these aspects and provided evidence, taken actions to further validate them (e.g. by successful and pending proposals for competitive public funding).