Waltham, MA, September 19, 2012 — EarlySense, the market leader in proactive patient care solutions, announced today the results of a post regulatory approval clinical and non- interventional prospective study supporting the effectiveness of the EarlySense contact-free patient monitoring system to accurately predict patient deterioration. The clinical study data will be published in the October 2012 print edition of the Journal of Hospital Medicine in an article entitled Early recognition of acutely deteriorating patients in non-intensive care units: Assessment of an innovative monitoring technology (Eyal Zimlichman MD, MSc, Martine Szyper-Kravitz MD, Zvika Shinar PhD, Tal Klap, Shiraz Levkovich, Avraham Unterman MD, Ronen Rozenblum PhD, MPH, Jeffrey M. Rothschild MD, MPH, Howard Amital MD, MHA, Yehuda Shoenfeld MD), DOI: 10.1002/jhm.1963. The article can also be accessed on line at http://onlinelibrary.wiley.com/doi/10.1002/jhm.1963/abstract.
Eyal Zimlichman, M.D., a lead researcher from the Center for Patient Safety Research and Practice, Brigham and Women’s Hospital and Harvard Medical School in Boston, MA said, “We used the EarlySense system to monitor the heart rate and respiration rate of patients admitted to the medical ward. The EarlySense monitor was able to continuously measure respiration and heart rates, providing low alert frequency. When tracking adverse clinical events for patients monitored by the Earlysense device, we found the monitor was able to identify hours ahead of time most of these events. The current study provides data supporting the ability of this system to accurately predict patient deterioration.”
The EarlySense System uses a sensor, placed under the mattress of a bed, and never touches the patient. The EarlySense System is designed to detect early warning signs of deterioration by continuously monitoring heart rate, respiratory rate, movement, bed exits and entries. The technology was designed to monitor non-ICU ‘lower risk’ patients on medical surgical floors who are usually monitored by on-duty nurses once every four to five hours. In the event of a change in a patient’s status, the system immediately alerts on-duty nurses at the central nursing station, on large screens on the wall of the department and on their handheld devices. EarlySense’s real time delivery of actionable data, coupled with comprehensive unit management tools, empowers the medical staff to identify critical situations early on and proactively respond.
“This study supports the commonsensical idea that a robust system to non-invasively monitor patients’ vital signs can catch signs of early deterioration – potentially preventing embers from turning into firestorms,” said Robert M. Wachter, Professor of Medicine at the University of California, San Francisco, one of the nation’s top authorities on patient safety and a member of the EarlySense Medical Advisory Board. “Given the challenges of ‘alert fatigue’, I was particularly heartened by the infrequency of false alarms seen in this study. This innovative technology is an important step forward in our efforts to keep patients safe.”
“At EarlySense we strive to provide solid clinical evidence of how the utilization of our device can help clinicians deliver a higher level of care and secure a better outcome for patients. Many scientific articles in well-known peer-reviewed journals, including the one announced today, clearly support the need for continuous monitoring on general floors to be a standard of care,” said Dalia Argaman, vice president of clinical and regulatory affairs.
The clinical study was performed in two different medical departments at two separate academic medical centers. Sensitivity and specificity in predicting deterioration was found to be 82% and 67%, respectively, for HR and 64% and 81%, respectively, for RR. For trend alerts, sensitivity and specificity were 78% and 90% for HR, and 100% and 64% for RR, respectively.
“Hospitals are constantly striving to provide efficient, high quality care while preventing Joint Commission defined Sentinel Events. It is clinically proven that early detection of warning signs helps medical teams to secure better clinical outcomes. Today’s data further proves that the EarlySense system is a dependable tool to assist clinicians in detecting these early warning signs. This enables the medical team to manage their time more efficiently and proactively respond to the patients who are in the greatest need at any given moment,” said Avner Halperin, CEO of EarlySense.