Clinical Deterioration

Clinical Deterioration

Healthcare professionals worldwide aim to detect clinical deterioration early, aiming to optimise outcomes and prevent adverse events [1]. Clinical deterioration refers to the sudden decline in a patient’s condition, often characterised by subtle changes in vital signs or mental status. Traditional patient monitoring methods rely on periodic assessments, often missing crucial signs of decline, resulting in severe risks to patient safety [2, 3]

Early Warning Scores (EWS)

To address the challenge of promptly recognising clinical deterioration, the healthcare sector has embraced EWS. These scores offer a structured approach by assigning points based on the severity of deviations from a patient’s expected vital signs and other clinical parameters. Implementing EWS has demonstrably improved the detection of at-risk patients, facilitated improved communication among healthcare staff, and contributed to better patient outcomes. However, current EWS can trigger many false positives due to reliance on individual measurements at set intervals. This burdens patients and healthcare staff and hinders its use in mobile settings. Additionally, the dependence on individual assessments introduces the risk of human error during data collection and interpretation.

The Corsano Early Warning Score (Cor-EWS)

At Corsano, we redefine EWS by harnessing the power of continuous vital sign monitoring. Our proprietary Corsano (continuous) Early Warning Score (Cor-EWS) goes beyond conventional EWS by analysing real-time physiological data collected by the Corsano SmartBracelet. Unlike traditional EWS, which relies on intermittent measurements, Cor-EWS provides an objective and real-time vital parameter assessment, facilitating both in-hospital and ambulatory monitoring. Furthermore, with the integration of advanced artificial intelligence (AI) and machine learning techniques analysing the uninterrupted raw data streams, the Cor-EWS not only detects the presence of clinical deterioration but also predicts its likelihood. This predictive capability empowers healthcare teams to intervene proactively, potentially averting adverse events and improving patient outcomes. 

Functionality

The Cor-EWS uses advanced data analytics techniques, including statistical models, machine learning, and AI. Initially, personalised baselines for vital parameters such as pulse rate (PR), heart rate variability (HRV), Oxygen saturation (SpO2), Respiration Rate (RR), cuffless non-invasive blood pressure (NIBP), and core body temperature (CBT) are established for each individual. Subsequently, real-time vital parameter data, facilitated by the Corsano SmartBracelet, is continuously compared against the established baselines to pinpoint any deviations indicative of clinical deterioration. The baselines consider a person’s unique physiological norms, influenced by factors such as age, gender, medical history, and lifestyle, while also factoring in healthy physiological variations like metabolic needs, activity levels, and circadian rhythms. Importantly, Cor-EWS incorporates a dynamic baseline adjustment mechanism that adapts over time based on changes in the patient’s health status, treatment interventions, and other relevant factors, ensuring the accuracy and reliability of its baseline predictions. The Cor-EWS also incorporates the interrelationships among vital parameters, uncovering patterns and associations that might otherwise go unnoticed but signify impending deterioration. By not only detecting existing clinical decline but also predicting its likelihood, the Cor-EWS empowers healthcare teams to intervene proactively. Consequently, it enhances patient safety and elevates the quality of care, whether in hospital or ambulatory settings.

Flexibility and Adaptability

The Cor-EWS prioritises adaptability to accommodate the diverse preferences of healthcare professionals, ensuring optimal usability and effectiveness. Addressing the delicate balance between EWS interpretability and the integration of advanced analytics, such as machine learning or AI, different versions of Cor-EWS are developed with varying degrees of machine learning implementation. This approach provides flexibility, allowing users to select the level of machine learning integration that best suits their clinical needs. Furthermore, our systems can seamlessly integrate conventional EWS frameworks in clinical practice, enhancing their functionality and utility. Customisable alerts further improve the adaptability of the Cor-EWS, allowing users to set parameters specific to their patient populations and clinical environments.

Customised Cor-EWS for Medical Indications

Tailoring the Cor-EWS to specific medical indications enhances its clinical usability and effectiveness. Our system can use advanced data analytics to pinpoint the most important physiological parameters for accurately detecting or predicting each clinical scenario. Additionally, the Cor-EWS can integrate supplementary components, such as health or neurological questionnaires. Multiple projects are ongoing focusing on developing customised Cor-EWS capable of detecting and predicting a range of medical indications.

Sepsis

Sepsis is a life-threatening condition precipitated by an overwhelming immune response to infection, leading to tissue damage and organ dysfunction [4]. Delayed diagnosis and intervention significantly escalate mortality rates [4]. The Global Burden of Disease study in 2017 estimated that sepsis occurred 49 million times, claiming 11 million lives [5]. Consequently, the World Health Organization (WHO) recognised sepsis as a global health priority in 2017, urging member states to enhance early detection and management efforts [6].

While timely diagnosis and effective antimicrobial therapy improve sepsis outcomes [7, 8], early and accurate detection remains a formidable challenge. The CorSep-EWS may be an essential tool in sepsis management, offering a critical avenue for early detection and prediction of this life-threatening condition. Through its proactive approach and predictive insights in both the hospital and ambulatory setting, the CorSep-EWS has the potential to save lives and alleviate outcomes for patients worldwide.

Transfusion and Transplantation

Patients undergoing transfusion or transplantation procedures face inherent risks, including hemodynamic instability, fluid overload, and graft rejection [9, 10]. Hemodynamic instability can result from rapid transfusions or reactions to blood products, leading to complications such as hypotension or cardiac arrhythmias. Fluid overload, on the other hand, may occur due to excessive fluid administration during transfusion or impaired renal function, potentially resulting in pulmonary oedema or compromised cardiac function. Graft rejection is a critical concern in transplantation, where the recipient's immune system identifies the transplanted organ as foreign and mounts an immune response, leading to organ failure if not promptly treated.

CorTrans-EWS monitors these parameters and employs advanced algorithms to detect subtle changes indicative of impending complications. By providing early warning signs, CorTrans-EWS enables healthcare providers to intervene proactively, preventing adverse events and optimising patient outcomes during transfusion and transplantation procedures. Parameters such as haemoglobin levels, fluid balance, renal function, and graft function can be seamlessly integrated into the Cor-EWS algorithm, bolstering its effectiveness and usability. By providing vigilant monitoring tailored to the unique needs of transfusion and transplantation patients, CorTrans-EWS plays a crucial role in optimising patient outcomes and ensuring the success of these critical medical interventions.

Chimeric Antigen Receptor (CAR) T Cell Immunotherapy

Chimeric Antigen Receptor (CAR) T-cell therapy represents a groundbreaking approach to cancer treatment, harnessing the power of genetically engineered T cells to target and destroy cancer cells. While offering remarkable potential for durable remissions, CAR T cell therapy is accompanied by an elevated risk of severe side effects, notably cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) [11, 12]. CRS results from an immune system overreaction, leading to systemic inflammation, fever, and potential organ dysfunction, while ICANS manifests as neurologic toxicity, including confusion and seizures.

The CorCAR-EWS specialises in monitoring patients following CAR T cell therapy, facilitating early detection of CRS and neurotoxicity manifestations. By continuously monitoring vital signs and neurologic status, CorCAR-EWS enables healthcare providers to identify and intervene in these potentially life-threatening complications promptly. This system plays a crucial role in ensuring patient safety during therapy associated with such significant risks of adverse events.

Traditionally, patients undergoing CAR T cell therapy are required to remain hospitalised for a predetermined period due to the heightened risk of complications. However, with the implementation of CorCAR-EWS, patients may now be discharged from the hospital if their risk of complications is deemed low based on our predictive algorithms. This enables patients to transition to ambulatory care settings while still under vigilant monitoring. Healthcare workers are promptly alerted should the CorCAR-EWS indicate an increased risk of complications, allowing for timely intervention and proactive management. The integration of CorCAR-EWS not only enhances patient safety but also optimises healthcare resource utilisation by enabling a more tailored and flexible approach to post-CAR T cell therapy monitoring.

Pharmacovigilance

Pharmacovigilance, the systematic monitoring of medication safety, encompasses identifying and evaluating adverse drug reactions. CorPharm-EWS contributes to this endeavour by enabling continuous surveillance for medication-induced therapies. By analysing vital signs, with the potential to incorporate laboratory data and patient-reported symptoms, CorPharm-EWS can detect subtle changes indicative of adverse drug reactions. This allows for early intervention, preventing further patient harm. Additionally, CorPharm-EWS facilitates seamless communication between healthcare providers, promoting collaborative decision-making in patient care.

Oncologic Therapies

Real-time monitoring for treatment-related complications is essential during oncological therapies such as chemotherapy and radiotherapy. CorOnc-EWS addresses this need by providing early warnings of clinical deterioration in patients undergoing these treatments. This allows for timely intervention, including adjustments to treatment regimens, implementation of supportive care measures, or administration of growth factors to stimulate blood cell production.

References

1. Burke JR, Downey C, Almoudaris AM. Failure to Rescue Deteriorating Patients: A Systematic Review of Root Causes and Improvement Strategies. J Patient Saf 2022;18(1):e140-e155.

2. Azimirad M, Magnusson C, Wiseman A, et al. Nurses' ability to timely activate rapid response systems for deteriorating patients: A comparative case scenario study between Finnish and British nurses. Intensive Crit Care Nurs 2020;60:102871.

3. Bleyer AJ, Vidya S, Russell GB, et al. Longitudinal analysis of one million vital signs in patients in an academic medical center. Resuscitation 2011;82(11):1387-92.

4. Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016;315(8):801-10.

5. Rudd KE, Johnson SC, Agesa KM, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet 2020;395(10219):200-211.

6. (WHO) WHO. Improving the prevention, diagnosis and clinical management of sepsis WHA70.7. In. Seventieth World Health Assembly; 2017.

7. Rudd KE, Kissoon N, Limmathurotsakul D, et al. The global burden of sepsis: barriers and potential solutions. Crit Care 2018;22(1):232.

8. Seymour CW, Gesten F, Prescott HC, et al. Time to Treatment and Mortality during Mandated Emergency Care for Sepsis. N Engl J Med 2017;376(23):2235-2244.

9. Khan AI, Gupta G. Noninfectious Complications of Blood Transfusion. In. StatPearls. Treasure Island (FL); 2024.

10.⁠ ⁠Sen A, Callisen H, Libricz S, et al. Complications of Solid Organ Transplantation: Cardiovascular, Neurologic, Renal, and Gastrointestinal. Crit Care Clin 2019;35(1):169-186.

11.⁠ ⁠Santomasso B, Bachier C, Westin J, et al. The Other Side of CAR T-Cell Therapy: Cytokine Release Syndrome, Neurologic Toxicity, and Financial Burden. Am Soc Clin Oncol Educ Book 2019;39:433-444.

12.⁠ ⁠Morris EC, Neelapu SS, Giavridis T, et al. Cytokine release syndrome and associated neurotoxicity in cancer immunotherapy. Nat Rev Immunol 2022;22(2):85-96.