Single-Use Wearable Wireless Sensors for Vital Sign Monitoring

CADTH Horizon Scan

Authors; Michelle Clark, and Sharon Bailey.

Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2023 Nov.

Report No.: EN0048

What Is the Issue?:

The monitoring of vital signs is a key component of patient care. Metrics such as heart rate, body temperature, respiratory rate, and oxygen saturation allow health care staff to monitor the well-being of their patients.

What Is the Technology?:

Single-use, wearable devices for vital sign monitoring have a variety of designs that are embedded with sensors that allow for continuous monitoring. They transmit data wirelessly to a base unit within a health care setting or a home.

What Is the Potential Impact?:

For patients in the hospital, single-use wearable monitors can allow for fewer interruptions to rest. For patients leaving the hospital, the wearable monitors can allow for peace of mind and earlier discharge because the individual continues to be monitored remotely. In out-of-hospital settings, vital sign monitoring can signal when a person should seek additional care. The potential impacts may extend to caring for older adults at home.

What Else Do We Need to Know?:

This Horizon Scan summarizes information regarding the effectiveness, safety, cost, and other considerations should there be a broad implementation of emerging wearable devices for the remote measurement of vital signs.

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Wearable Wireless Sensors May Allow for Early Discharge

Wearable devices can allow for vital sign monitoring without interruption from health care staff or can be carried out in the comfort of people’s own homes with the capacity to continue to monitor their vital signs remotely allows an earlier discharge from the hospital after a procedure.

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What Is the Technology?

There are a variety of designs of single-use wearable devices for vital signs and patient monitoring. These include wrist and arm bands, watches, Holter devices, and patches. Wearable wireless sensors include the BioSensor, Healthdot/HealthPatch, Sensium, and VitalPatch, among others. They are embedded with small sensors that allow for continuous patient monitoring. These devices can be medical grade (intended for use by trained health care providers only) or consumer grade (intended for use by the consumer without needing health care provider involvement). In this report, we are focused on single-use wearable devices that can be adhered to the skin, have an internal power source, and transmit information wirelessly to a base unit in the patient’s home or with the health care provider. Notifications are sent to the health care provider when readings fall outside of preset thresholds to alert them to potential deterioration of the patient. The BioSensor, Healthdot/HealthPatch, Sensium, and VitalPatch that measure biometric data such as:

• physical activity level
• body posture
• sleep quality
• blood oxygen saturation
• heart rate (HR)
• respiratory rate (RR)
• skin temperature.

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Who Might Benefit?

Single-use wearable wireless devices for continuous vital sign monitoring may benefit a variety of groups. When continuous monitoring is used for hospital inpatients, the ability to accurately monitor patient’s vital signs remotely means minimizing disruptions to the patient to obtain these measurements manually. They also allow for health care providers to safely monitor patients hospitalized with an infectious disease while minimizing their own exposure to potential infection. Additionally, they have the potential to allow for simpler freedom of movement for people in hospital who are able to leave their beds and their rooms – reducing the number of wires and sensors that must be detached and reattached.

Out-of-hospital vital sign monitoring can allow for earlier discharge for surgical patients; they can return home sooner than without it, while still being monitored by a health care provider for signs of infection or distress. It also allows for remote monitoring of people who have an infectious disease, such as COVID, in both hospital and out-of-hospital settings; protecting both the health care providers and their family caregivers from further exposure to infection. The benefits of such devices may also extend to caring for older adults at home.

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Availability in Canada

The single-use wireless wearable vital sign monitoring devices identified in this report were not listed in the Health Canada Medical Devices Active Licence database as of the writing of this report. These devices have been available for use in the US and the UK since the early 2010s.

The VERDICT-2 trial is a research study that began in April 2023 by researchers at Population Health Research Institute of Hamilton Health Sciences and McMaster University assessing the accuracy of the Vitaliti, a new wearable patch developed by a Canadian company, Cloud Dx, compared to standard monitoring equipment.¹ The Vitaliti patch continuously tracks electrocardiogram (ECG) measurement, heart rate (HR), pulse rate, respiratory rate (RR), temperature, blood pressure, and oxygen saturation. When the accuracy study is complete, the researchers plan to study patient experience wearing the device at home. A large-scale effectiveness and usability study will follow this.¹

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What Does It Cost?

No Canadian prices for these devices were identified.

The authors of a cost-utility analysis of continuous and intermittent versus intermittent vital signs monitoring in patients admitted to surgical wards in the UK using the SensiumVitals device for continuous monitoring found that continuous vital sign monitoring with additional intermittent monitoring was less costly than intermittent monitoring alone.² The cost of the Sensium patch was reported as £150 and the cost per patient to use the patch (including installation, annual licensing fees, staff training, and system maintenance) was estimated to be £350 per patient.² Over a 30-day time horizon, the total cost per patient was £6,329 for intermittent monitoring versus £5,863 for the combined monitoring group.² Reduced costs of hospital readmissions and length of stays in hospital drove the estimated cost savings.

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Current Practice

Depending on the setting and facility, vital signs are monitored either manually (using stethoscopes, blood pressure cuffs, thermometers, etc.) or via wired digital vital sign monitors (where wired sensors such as blood pressure cuffs are attached to both the patient and the monitor).^3,4 Measurements from both methods can be charted with pen and paper or transferred to an electronic record; however, as long as the systems are compatible, wired digital monitors allow for the transfer of vital sign data digitally – without the risk of transcription error.⁵

No Canadian guidelines recommending the appropriate frequency of vital sign monitoring or guidelines specifically related to the use of single-use wearable vital sign monitoring devices, at home or in hospital, were identified. In a July 2022 CADTH summary of abstracts report, Assessment of Postoperative Vital Signs Frequency, 2 evidence-based guidelines were identified.⁶ It was recommended that general postoperative patients should have their oxygenation monitored continuously until they are no longer at risk for hypoxemia or respiratory depression and ventilation and circulation could be monitored at regular intervals (e.g., every 5 to 15 minutes) until patients are suitable for discharge. For patients who have undergone bariatric surgery, continuous monitoring of vital signs during the early postoperative period was recommended until patients were no longer at risk for respiratory depression.⁶

An observational study of vital sign measurement on the general medical ward of a hospital in the US found that vital signs were most often measured 6 times per day or about once every 4 hours.⁷ The frequency of measurement ranged from 1 to 24 times per day.

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What Is the Evidence?

Clinical studies were identified regarding 4 wearable vital sign monitoring devices: the BioSensor, Healthdot/HealthPatch, Sensium, and VitalPatch. The characteristics and results of these studies are summarized in Table 1, Appendix 2.

As reported in the studies, the BioSensor measured HR, RR, skin temperature, posture and can detect patient falls.⁸ The Healthdot measured HR every 8 seconds and RR measurements every second.⁹ The Sensium Vital Sign Sensor measured HR, RR, and temperature^10, and the VitalPatch measured HR, HR variability, RR, skin temperature, body posture, and steps taken.¹¹

In Hospital

BioSensor

Kant and colleagues (2022) found that all HR measurements from the BioSensor were within the limits of agreement with the reference monitor of 8 beats per minute. The RR measurements exceeded the 2 respirations per minute limit of agreement in 58% of compared measurements. A data loss of 4.5% was observed.⁸

Healthdot and HealthPatch

Three studies were identified examining the use of the Healthdot and HealthPatch.^9,12,13 All 3 were based on subsets of the TRICA study, a prospective, single-centre observational study of postsurgical patients.

• For adult patients recovering from major abdominal cancer surgery, the authors found that the wearable patch detected the same number of true clinical deteriorations as vital sign monitoring with manual spot checks.⁹
• Another study of the same population determined that 97% of HR measurements were within the 5 beats per minute limit of the gold standard measurement and 87% of RR measurements were within the 3 respirations per minute limit.¹²
• For adults undergoing bariatric procedures, 87.5% of the HR data met the 5 beats per minute limit and 92.3% of RR data met the limit of 5 respirations per minute.¹³

Sensium Vital Sign Monitor

The Sensium Vital Sign Monitor was assessed in 3 publications and used for adults hospitalized following surgery.^14–16

• For abdominal surgery, the algorithm sent 972 alerts (90.3% system alerts, 9.7% vital sign alerts). It was determined that only 35% of the vital sign alerts were true positives.¹⁴
• Patients who had undergone major elective surgery were randomized to receive either remote monitoring plus National Early Warning Score (NEWS) monitoring or manual monitoring using NEWS alone.^15,16
  • The authors found there was no clinically meaningful bias in HR but the precision of the patch was poor. Overall agreement was poor for RR and temperature.¹⁶
  • A second study assessed the ability of continuous monitoring to detect sepsis.¹⁵ On average, the patients who were continuously monitored received antibiotics for sepsis sooner and had a shorter average hospital stay and were less likely to require readmission within 30 days of discharge; however, the differences between groups were not statistically significant.

Outpatient

VitalPatch

Outpatient and out-of-hospital use of the VitalPatch was assessed in 3 clinical studies.^11,17,18

• Patients discharged early after esophagectomy were provided with the VitalPatch device to allow health care providers to check on their vital signs remotely following surgery.¹¹ Overall data loss of vital sign measurements at home was 25%. Clinical decision-making was not altered based on the trends observed in the remotely obtained vital sign measurements.¹¹
• Stehlik et al.¹⁷ aimed to determine the accuracy of machine learning analytics of a remote patient monitoring system in predicting heart failure (HF) hospital readmission. The remote vital sign monitors provided data sufficient to predict 87% of hospitalizations and 87.5% of unplanned nontrauma hospitalizations.¹⁷ Patient compliance with the device was high with 87 of 100 participants completing 30 days of monitoring and 74 completing 90 days of monitoring.¹⁷
• Tonino et al.¹⁸ assessed the wearability, usability, and safety of use of the VitalPatch system for adults with a confirmed hematological disorder who were monitored during transfusion therapy. Patient-reported outcomes were not dependent on whether the patient or a nurse applied the patch. The devices were generally well tolerated and remained in place during use.

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Safety

No patient safety concerns were described in the clinical studies aside from adhesive reactions. For the VitalPatch, no reports of skin irritation were reported in 1 clinical study;¹¹ however, 3 patients withdrew from another study due to skin irritation related to the device’s adhesive.¹⁸

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Issues to Consider

The hope is that these types of devices will help to lessen burden on the health care system by reducing the number of required patient and/or provider interactions. Continuous remote monitoring of vital signs saves time for providers and lessens bother and disruption to the patient. The use of these devices may free up hospital rooms through earlier discharge paired with safe and appropriate postsurgical monitoring done remotely. There is a need to ensure the devices strike the balance between adequate measurement accuracy and overreaction to changes in vital signs, resulting in excessive notifications sent to health care providers.

Patients’ Perspectives and Experiences

Sensium Patch

For adults following abdominal surgery, the majority of patients rated the Sensium patch as comfortable.¹⁴ More than half of patients said they felt safer knowing they were wearing the monitoring patch and 89% said they would like to wear 1 if they were in hospital again.¹⁴ Downey et al.¹⁵ similarly found that patients found the device to be acceptable in terms of comfort and perceived an enhanced sense of safety knowing the device provided continuous monitoring. Joshi et al.¹⁰ conducted a study of patient’s perspectives related to the use of the Sensium monitor while in hospital. Of the 500 patients who wore the sensor, 453 completed the questionnaire. The respondents generally agreed that the patch was comfortable to wear (94.3%) and that they would agree to wear it again when in hospital (94.7%) and 87.9% agreed that they would wear the patch at home.¹⁰ As was found in other studies, the patients said the patches improved their sense of safety and they felt they could help to relieve pressure on health care staff.¹⁰

VitalPatch

In the outpatient setting, patients who were discharged early with the VitalPatch following esophagectomy were happy to have the ability to have their vital signs monitored remotely. They appreciated the daily check-ins from their health care providers during the postoperative period.¹¹

Health Care Provider Experience

Nurses were neutral about the usefulness and satisfaction with the Sensium Vital Sign Monitoring Patch but generally agreed that the system was easy to use.¹⁴ In 1 study of the VitalPatch, nurses reported the device was easy to use, and they were comfortable relying on the data it measured.¹⁸

Article by, NIH.

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