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Why Sutter Health is using a wearable device for critical care

Sutter Health is adopting a wearable device to enhance sepsis management that will provide critical care clinicians with real-time data to support clinical decision-making.

Critically ill patients in the intensive care unit can deteriorate in the blink of an eye. To avoid patient harm that could result in death, clinicians must be able to make rapid and effective treatment decisions. Healthcare wearable devices can significantly enhance clinical decision-making in the ICU, as they provide real-time data to support treatment decisions.

One California-based health system recently turned to a unique wearable device to improve care for intensive care unit patients. Sutter Health announced last month that it will implement Flosonics Medical's FloPatch wireless, wearable Doppler ultrasound device in its ICUs for sepsis management.

Sepsis occurs when a patient has an extreme physical response to an infection, according to the CDC. Sepsis can cause rapid patient deterioration, leading to tissue damage, organ failure and death. Around 1.7 million American adults develop sepsis yearly, of which around 350,000 die during their hospitalization or are discharged to hospice.

Research shows that advanced technology can improve sepsis management. For instance, a study published in January 2024 revealed an artificial intelligence model deployed in emergency departments to forecast patients' sepsis risk significantly reduced mortality. The study evaluated outcomes for over 6,000 patients and found that sepsis mortality rates dropped by 17% after the model's deployment.

With the FloPatch wearable device, Sutter Health aims to enhance fluid management, which can help make sepsis treatment more precise. The health system plans to go live with the device in its ICUs on Sept. 9, 2024. In the lead-up to the deployment, the organization is working to ensure a smooth rollout among its staff.

Understanding sepsis management challenges

Over the past two decades, a concerted effort has been made to reduce sepsis risk and mortality. In 2002, the Society of Critical Care Medicine and the European Society of Intensive Care Medicine launched the Surviving Sepsis Campaign, which created evidence-based guidelines and recommendations for sepsis management.

Any delay in correcting the [blood] circulation to that vital tissue is going to cost you tissue cells, and you'll have cell death. So, time is tissue, which is the term we use. Time is tissue.
Kristina Kury, MDMedical director of critical care, Sutter's Eden Medical Center

According to Kristina Kury, MD, medical director of critical care at Sutter's Eden Medical Center, the health system has used these guidelines to significantly reduce sepsis mortality. However, ensuring the guidelines are applied appropriately can be challenging, especially because time is of the essence when a patient develops sepsis.

Kury emphasized that ensuring blood flow to vital organs is critical in effective sepsis management.

"You can think of sepsis really in a similar way as you think of somebody who has a heart attack or somebody who has a stroke," she said. "Any delay in correcting the [blood] circulation to that vital tissue is going to cost you tissue cells, and you'll have cell death. So, time is tissue, which is the term we use. Time is tissue."

Thus, fluid resuscitation, wherein fluids and electrolytes are administered to maintain oxygen and nutrient delivery through blood flow, is an important aspect of sepsis treatment.

However, the underlying infection that results in sepsis can complicate treatment protocols.

For instance, the guidelines suggest applying vasopressors if the patient is hypotensive during or after fluid resuscitation. But patients with different conditions, such as structural heart disease or advanced kidney disease, will have different responses to fluids.

"That's where a lot of the conundrum is -- what's appropriate, what's adequate?" Kury explained. "When do we stop giving fluids? When do we start vasopressors? That's been a tricky area to navigate for most clinicians, ED physicians and ICU physicians alike."

How will the wearable device help?

Implementing the sepsis management guidelines accurately requires reliable data; this is where the FloPatch device comes in.

Previously, clinicians relied on indirect surrogate methods to assess fluid volumes in a patient, including stroke volume or the amount of blood pushed out of the heart to support blood circulation to the vital organs, Kury said. However, the surrogate methods are focused more on the right side of the cardiovascular system, called the venous side, which does not always give clinicians an accurate sense of the patient's fluid needs.

The FloPatch device focuses on left-sided physiology or heart function. It uses ultrasonography technology to assess blood flow through the carotid arteries. The device is placed over the carotid arteries in the neck and collects carotid Doppler waveform data, which can be used to calculate corrected carotid flow time.

"[Corrected carotid flow time] represents basically a relationship between the stroke volume, which is that amount of blood that's pushed out with each [heart] beat, and the time it takes for the heart muscle to project that volume," Kury explained.

The device is remotely connected to an iPad or a tablet, allowing clinicians to gather waveform data and calculate corrected carotid flow time to assess whether the patient is responsive to fluid resuscitation.

If a patient is fluid-responsive and hypotensive, clinicians can give them more fluids before starting vasopressors to correct their hypotension, Kury said. On the other hand, if the patient's cardiac function deteriorates with fluid resuscitation, clinicians will avoid giving them more fluid and move on to vasopressor support more quickly.

Without accurate data collection and stroke volume measurement, clinicians are flying blind concerning fluid resuscitation, which can have devastating consequences.

"If we guess wrong on the side of giving too much fluid, the risk is we put somebody into respiratory failure because the fluid builds up in their lungs," she explained. "[And if you're] not administering fluids and starting vasopressors too quickly, or just delaying correction, then you're not getting the blood supply to vital organs, and one of the most vulnerable organs are kidneys, and people can go into kidney failure."

Though other technologies have been developed to assess blood flow for sepsis management, they tend to be bulky, labor-intensive and time-consuming. In fact, Sutter had invested in a noninvasive cardiac output monitor, which had those limitations, Kury noted.

She added that the monitor takes nearly 30 minutes to provide the necessary data for a clinician to feel comfortable acting. Meanwhile, the wearable device is easy to use, can be reused, and provides real-time actionable data.

Rolling out the wearable technology

The health system plans to go live with the new technology on Sept. 9, 2024, in Sutter's Eden Medical Center and Sutter's California Pacific Medical Center before scaling it systemwide. The wearable device will be deployed not only in the ICUs and EDs but also in the trauma units, where fluid resuscitation and stroke volume measurement are critical.

Sutter Health has identified critical care nurse champions to support ICU, hospitalist, and trauma clinicians during the rollout.

"That way, we really have some experts, and they will be the ones who socialize it with the bedside nurses and get everybody using it," Kury said.

Changing care processes and learning new technology is a perennial health IT challenge. Kury highlighted the resistance to change and skepticism that characterizes technology integration in most healthcare settings.

To ease clinicians' concerns and overcome resistance, Sutter Health gave the bedside nurses a questionnaire asking their thoughts on the FloPatch wearable device, including whether they would find it useful. The response was largely positive.

"There's no question learning curves are always going to be there, but that initial enthusiasm and when people see really how easy this is, it'll be embraced pretty quickly," Kury said.

Following the deployment of the device, Sutter Health will track various metrics to assess its efficacy in improving critical care outcomes. The health system hopes to reduce sepsis morbidity and mortality, as well as the number of patients requiring intubation, renal replacement therapy, or dialysis.

"If we can even drop the mortality and morbidity just by a couple percentage points with this, that's thousands of lives saved," Kury said. "It's thousands of fewer ventilator days, [fewer] hospital days, [and] people get home sooner and have fewer complications. It really could revolutionize the treatment of sepsis because we've really hit a little plateau on our sepsis improvement. We've done great stuff but getting to the next level has been a big challenge, and I think there's a good chance this may be that thing that just pushes us a little further along in that direction."

Anuja Vaidya has covered the healthcare industry since 2012. She currently covers the virtual healthcare landscape, including telehealth, remote patient monitoring and digital therapeutics.

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