Tackling Sepsis with Safer, Non-Invasive Technologies

It’s about time. The sooner sepsis is recognized and diagnosed, the greater the chances of preventing its progression to life-threatening shock.

Sepsis is the body’s overactive and extreme response to an infection that can lead to shock and cause tissue damage, organ failure and even death if not quickly treated.

September is Sepsis Awareness Month, and organizers are emphasizing the importance of TIME by calling attention to these key symptoms:

TTemperature that’s abnormal

I – Signs of Infection

M Mental Decline

E  – Extremely Ill

Indeed, a New England Journal of Medicine study found that each hour of delay in a 3-hour sepsis treatment bundle (including blood cultures, serum lactate and broad-spectrum antibiotics) was associated with increased mortality. (Seymour)

Sepsis is an umbrella term for cases of sepsis, sepsis with organ dysfunction and septic shock. There are multiple pathways to developing the condition, making it difficult to recognize. Yet, it is far more widespread than people realize.

In 2017, sepsis was estimated to affect nearly 50 million people globally and cause an estimated 11 million deaths. In the U.S., sepsis is the leading cause of death in hospitals annually, resulting in nearly 270,000 deaths. (CDC)

At the same time, sepsis is the most expensive U.S. hospital condition, costing nearly $24 billion annually. (Torio, NIH)

Early Detection, Treatment Optimization Critical

Increasing understanding and awareness of sepsis is essential to ensuring early recognition and treatment, which ultimately can save lives, reduce healthcare costs and improve patient outcomes. As with most medical conditions, the sooner sepsis is detected, the better the outcomes and the simpler the tools needed to treat it.

Equally important to a timely diagnosis is personalizing and optimizing treatment for each individual patient. Sepsis symptoms resemble those of other conditions, causing it to be mistaken for other conditions or even treated incorrectly.

For example, patients with sepsis may have either normal or low blood pressure readings. Another major sepsis indication is below-normal central venous oxygen saturation (SvcO2). Its prompt detection enables immediate treatment that can reduce severe outcomes like multisystem organ failure and death.

Yet, even when low ScvO2 is detected, the proper treatment course is not always clearcut. In some cases, increasing intravenous fluids can be effective, but in others, it can make matters worse. Clearly, there is a need for new technologies that not only detect sepsis but can monitor whether treatment is making a difference in real time.

Current ScvO2-measurements are invasive, requiring time and skill to insert a catheter directly into the patient’s blood stream, either for intermittent blood sampling or continuous oxygen level monitoring. This procedure can increase the risk of serious infections.

Other non-invasive, diagnostic tests for septic shock, such as blood pressure measurements, lab tests and ultrasounds do not directly evaluate ScvO2 and lack sensitivity and/or specificity.

Hospital-Acquired Sepsis Presents Challenges

It’s not a moment too soon for safer, faster sepsis-detection methods. While the “Surviving Sepsis Campaign” clinical guidelines have improved emergency department diagnosis and treatment of community-acquired cases, hospital-acquired sepsis is still a major problem, affecting approximately 30% of intensive care patients globally (Sakr, Open Forum Infect Dis) and leading to longer hospital stays and mortality rates exceeding 40%. (Markwart, Intensive Care Med)

Septic shock is probably more common in the hospital because patients are sicker and more vulnerable to infection, Madeleine Biondolillo, vice president of quality innovation at Premier Inc., told Modern Healthcare. A report by Premier, a healthcare improvement company, found that the average cost per case for hospital-associated sepsis increased from $58,000 in October 2015 to about $70,000 in September 2018.

Non-Invasive Tools Potentially Safer, More Effective

Fortunately, potentially more effective, non-invasive tools are on their way. Noninvasix is expected to be the first company to non-invasively and continuously monitor sepsis by detecting ScvO2. Our patented optoacoustic platform consists of a disposable patient interface, reusable probe, data display and hardware.

The probe can be worn on a patient’s chest to continuously monitor central venous oxygen saturation levels in real time, potentially eliminating the need for invasive catheters and reducing infection risk. Our LIVOx Central Venous Oxygenation Monitor is designed to be incorporated directly into the Intensive Care Unit workflow, enabling clinicians to diagnose and monitor the response to treatment.

Noninvasix has completed two clinical studies of the LIVOx technology in adults and was evaluated in multiple peer-reviewed publications. The monitor received Breakthrough Device Designation from the U.S. Food & Drug Administration in February 2022. The company expects the platform to be on the market in 2024.

This month let’s acknowledge the improvements in sepsis detection and treatment but also call attention to the pressing need for innovative technologies. It’s about time.