Patent Application
20240164718
The following relates generally to the patient monitoring arts, wearable medical device arts, accelerometer arts, respiration monitoring arts, heart rate monitoring arts, patient activity monitoring arts, and related arts.
Health-related unobtrusive sensing systems enable replacement of continued hospitalization with obtrusive vital signs sensor technologies, centered around the individual, to provide remote monitoring of the subject's general health condition. Vital signs monitoring typically includes monitoring one or more of the following physical parameters: heart rate (HR), blood pressure (BP), respiratory rate (RR), core body temperature and blood oxygenation (SpO2).
To assess a patient's condition or to determine a patient's degree of illness, a clinical decision support algorithm is often used, such as the spot-check-based early warning score (EWS) system in a general hospital ward. These algorithms take vital signs signals (or a subset thereof) measured of a patient and analyse trends or compare values to predefined thresholds of assumed normal values for EWS systems. The output of these algorithms informs clinicians on the assumed physiological instability of the patient based on which, combined with non-physiological factors, the clinician can assess whether changes are needed in the patient's treatment plan. While these algorithms are aimed at instability detection, they are sometimes used as indirect indicator of patient stability, and patient stability algorithms are also being developed.
By way of unobtrusive wearable vital signs monitoring systems, like vital sign patches, continuous collection of vital signs is made feasible in lower acuity care settings like the general ward and at home. These vital sign patches are often based on accelerometery signals, photoplethysmography (PPG) signals, electrocardiogram (ECG) measurements, bio-impedance signals, inductive magneto-electrogram signal, resistance, etc.
To reduce hospital costs, improve patient, and staff satisfaction while keeping healthcare outcomes high (or even improved), hospitals can employ remote monitoring of patients. In some examples, remote vital sign monitoring with a wearable sensor enables patients to be discharged home earlier after hospitalization while they are still being observed by a healthcare professional. The remote vital sign monitoring acquires HR. RR, and/or other vital sign samples continually (that is, on a frequent basis. e.g., every 5 minutes in a nonlimiting illustrative example). If, based on Clinical Decision System (CDS) scores computed using these vital sign readings, the patient shows signs of deterioration, then action should be taken. Examples are a phone or video call to confirm compliance with medication intake, making minor medication dose adjustments, re-assessment by a home care clinician visit, and if necessary, readmitting the patient to the hospital.
For reliability, the continuous remote monitoring should give accurate alarms or notifications if deterioration occurs. An overabundance of false alarms, where an alarm or notification is raised erroneously and the patient is doing well after all, leads to alarm fatigue. Alarm fatigue can be amongst the top challenges that hospitals face and can be seen as a risk of using sensors in healthcare. In particular, for wearable sensors, movement artifacts in wearable sensor data can also result in an overabundance of false alarms, leading to alarm fatigue.
The continuous remote monitoring should also be reliable in obtaining vital signs data from the patient. This refers to technical and technological reliability, but also to reliability that the patient is using and wearing the sensor accurately and sufficiently. If the patient is not wearing the sensor, no remote monitoring can happen. This is especially risky when the hospital does not notice the sensor has been taken off and is still relying on alarms to arrive in case of deterioration. This issue of patients inadvertently taking off the wearable sensor is also an important criterium for pharmaceutical companies to rely upon remote vital sign monitoring when conducting clinical trials. In another example, the wearable sensor can have a dead battery. In a clinical trial setting, a lack of patient compliance in wearing a sensor can have significant effects on the possibility of alarm generation and may adversely impact conclusions drawn from the clinical trial. Yet another use of such a method and system is for healthcare providers (e.g., hospitals and the like) using remote monitoring of patients undergoing treatment. In a similar way as for the pharmaceutical research, healthcare providers want to track whether the treatment has a sufficient positive effect or whether it needs any adjustment, for which reliable wearing is a precondition.
The following discloses certain improvements to overcome these problems and others.
In one aspect, a system includes a monitoring device including an accelerometer, an on-board electronic processor, and a wireless transmitter or transceiver. The monitoring device is configured to be attached to a patient and the accelerometer configured to measure accelerometer data. A clinical information system includes at least one electronic processor. The clinical information system is operatively connected with the monitoring device via the wireless transmitter or transceiver of the monitoring device. The on-board electronic processor of the monitoring device and the clinical information system cooperatively perform a health status monitoring method including analyzing the accelerometer data to determine respiration rate data for the patient or an indication that respiration rate data cannot be determined from the accelerometer data; determining whether the monitoring device is attached to the patient based at least on the whether the analyzing determines that respiration rate data cannot be determined from the accelerometer data; and one of: in response to determining the monitoring device is attached to the patient, displaying health status information for the patient generated from the accelerometer data and the determined respiration rate data; or in response to determining the monitoring device is not attached to the patient, displaying an indication that the monitoring device is not attached to the patient.
In another aspect, a health status monitoring method includes: using a wireless monitoring device attached to a patient, measuring patient data; and using at least one electronic processor and as a function of time: analyzing the patient data to determine health status information for the patient including at least respiration rate data for the patient and storing the determined health status information for the patient; determining the monitoring device is no longer attached to the patient based at least on a determination that respiration rate data cannot be determined from the patient data; and in response to determining the monitoring device is no longer attached to the patient, storing an indication that the monitoring device is not attached to the patient.
One advantage resides in providing a reliable remote monitoring system for monitoring a patient.
Another advantage resides in reducing an amount of false alarms to treat a patient when the patient does not actually require treatment.
Another advantage resides in obtaining reliable vital signs of a patient from a wearable monitoring device.
Another advantage resides in accurately determining whether a patient is wearing a monitoring device.
Another advantage resides in dismissal of notifications and alarms received from sensors which are not being worn by a patient.
Another advantage resides in active tracing of patients not reliably wearing a sensor.
A given embodiment may provide none, one, two, more, or all of the foregoing advantages, and/or may provide other advantages as will become apparent to one of ordinary skill in the art upon reading and understanding the present disclosure.
The disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the disclosure.
As used herein, the singular form of “a”. “an”, and “the” include plural references unless the context clearly dictates otherwise. As used herein, statements that two or more parts or components are “coupled.” “connected.” or “engaged” shall mean that the parts are joined, operate, or co-act together either directly or indirectly. i.e., through one or more intermediate parts or components, so long as a link occurs. Directional phrases used herein, such as, for example and without limitation, top, bottom, left, right, upper, lower, front, back, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the scope of the claimed invention unless expressly recited therein. The word “comprising” or “including” does not exclude the presence of elements or steps other than those described herein and/or listed in a claim. In a device comprised of several means, several of these means may be embodied by one and the same item of hardware.
With reference to
The monitoring device 12 can include a sensor 14 (such as an accelerometer 14 configured to measure patient data or, more specifically, accelerometer data 15, or any other suitable data such as ECG data. EMG data. PPG data, and so forth), an on-board electronic processor 16, and a wireless transmitter or transceiver 18 (referred to hereinafter as a transceiver 18). In some embodiments, the electronic processor 16 is configured to collect the accelerometer data 15 from the accelerometer 14, and the transceiver 18 is configured to transfer the accelerometer data 15 to a clinical health information system 20 operatively connected with the monitoring device via the transceiver 18. As shown in
A consideration in design of the monitoring device 12 is battery life. For example, the Healthdot® device is designed to be attached adhesively to skin of the subject in the region of the lower left rib, and to be worn continuously for up to about two weeks, remaining attached as the subject engages in normal activities such as showering. To maximize battery life, the Healthdot® device employs a single sensor, namely an accelerometer, and the on-board electronic processor 16 derives a plurality of variables from the accelerometer data, namely activity, posture, heart rate (HR), and respiratory rate (RR). The Healthdot® device extracts these variables from the accelerometer data using the on-board processor 16, which facilitates integrating the Healthdot® device with a commercial clinical health information system 20. In other embodiments, it is contemplated to transmit the accelerometer data 15 as raw accelerometer data that is then processed by the clinical health information system 20 to derive the activity. HR. RR, and posture. Minimizing manufacturing cost is also a consideration. For example, the Philips Healthdot® is a single-use device which is disposed of after use. As it contains only electronic devices and contacts only the exterior skin of the patient, the Healthdot® device advantageously is not considered medical waste and can be disposed of as ordinary waste. In some examples, an adhesive of the Healthdot® device can be disposed so that the sensor portion of the Healthdot® device can be reused.
In
The health status monitoring method 100 can be performed as a function of time, using data such as that plotted in
With reference now to
At an operation 104, the clinical health information system 20 and/or the on-board electronic processor 16 analyze the accelerometer data 15 to determine health status information for the patient. In some examples, the health status information can comprise respiration rate data for the patient P. or can comprise an indication that respiration rate data cannot be determined from the accelerometer data 15. The determined health status information for the patient P can be stored at the clinical health information system 20.
At an operation 106, the clinical health information system 20 determines whether or not the monitoring device 12 is attached to the patient P based on, for example, at least a determination that respiration rate data cannot be determined from the accelerometer data 15. To do so, in some embodiments, a running average of respiration rate values over a predefined sliding time window can be determined from the accelerometer data 15. Each respiration rate value is indicative of respiration rate of the patient P. or a predetermined value that is not indicative of respiration rate of the patient P. The predefined sliding time window can include, for example, a range of 50 values and 60 values. The determination that respiration rate data cannot be determined from the accelerometer data 15 can also be based on a frequency of the predetermined values in the sliding time window of respiration rate values exceeding a predetermined threshold.
In some embodiments, in addition to respiration rate data, the analyzing operation 104 can determine heart rate data (or blood pressure) for the patient P. or an indication that heart rate data cannot be determined, from the accelerometer data 15. The determining operation 106 can then include determining whether or not the monitoring device 12 is attached to the patient P is based on whether the analyzing operation determines that heart rate data cannot be determined from the accelerometer data 15. To do so, in some embodiments, a running average of heart rate over the predefined sliding time window can be determined from the accelerometer data 15. Each heart rate value is indicative of heart rate of the patient P. or a predetermined value that is not indicative of heart rate of the patient P. The determination that heart rate data cannot be determined from the accelerometer data 15 can also be based on a frequency of the predetermined values in the sliding time window of heart rate values exceeding a predetermined threshold.
In some embodiments, in addition to respiration rate data and/or heart rate data, the analyzing operation 104 can determine activity data (i.e., movement, posture, position, and so forth) for the patient P. or an indication that activity data cannot be determined, from the accelerometer data 15. The determining operation 106 can then include determining whether or not the monitoring device 12 is attached to the patient P is based on whether the analyzing operation determines that activity data cannot be determined from the accelerometer data 15. To do so, in some embodiments, a running average of activity values over the predefined sliding time window can be determined from the accelerometer data 15. Each activity value is indicative of activity of the patient P. or a predetermined value that is not indicative of activity of the patient P. The determination that activity data cannot be determined from the accelerometer data 15 can also be based on a frequency of the predetermined values in the sliding time window of activity values exceeding a predetermined threshold.
Moreover, in addition to the accelerometer 14, the monitoring device 12 can optionally include dedicated respiration sensors, and/or heart rate sensors to directly determine the respiration rate data and/or heart rate data, respectively (rather than deriving these vital signs from accelerometer data).
At an operation 108, in response to the operation 106 determining that the monitoring device 12 is attached to the patient, health status information for the patient P generated from the accelerometer data 15 and the determined respiration rate data (and/or the determined heart rate data and/or the determined activity data) can be displayed on a display device 24 (e.g., a display of a workstation computer, a cellphone, a smart tablet, and so forth). Additionally or alternatively, in the operation 108 the determined respiration rate data (and/or the determined heart rate data and/or the determined activity data) can be stored in a patient electronic health or medical record (EHR or EMR) at the clinical health information system 20 for later retrieval or analysis by a clinician. Additionally or alternatively, in the operation 108 the determined respiration rate data (and/or the determined heart rate data and/or the determined activity data) can be analyzed to determine whether the patient is deteriorating, and if so the clinical health information system 20 outputs a suitable alarm to indicate the deterioration. For example, a nurses' station or other patient monitoring station can include a grid of status indicators for a set of monitored patients, and the alarm can be implemented as a flashing warning or other distinctive feature in the status indicator for the patient detected to be undergoing health deterioration. In some embodiments, in addition to respiration rate data, heart rate data, activity data, and posture data, other patient signals (e.g., blood pressure. SpO2, temperature, etc.) can be extracted from the accelerometer data 15 and analyzed to determine the health status information for the patient P.
At an operation 110, on the other hand, in response to the operation 106 determining that the monitoring device 12 is not attached to the patient P, an indication 26 at the monitoring device 12 is not attached to the patient P is displayed on the display device 24. The indication 26 that the monitoring device 12 is not attached to the patient P can be stored at the clinical health information system 20. Additionally or alternatively, in the operation 108 the record of determined respiration rate data (and/or heart rate data and/or the activity data) stored in the EHR or EMR at the clinical health information system 20 can record a suitable indicator that the monitoring device 12 is no longer being worn. For example, the indicator can include a flashing icon, an audible alarm, a visual message, and so forth. In this way, when a clinician later retrieves the data he or she is not misled by any occasional false HR and/or RR and/or activity data incorrectly measured after removal of the device 12. Similarly, an analysis to determine whether the patient is deteriorating is not performed if the operation 106 determines that the monitoring device 12 is not attached to the patient P. (However, optionally the operation 110 may update the patient's status indicator in a nurses station or other patient monitoring station to indicate that the monitoring device 12 is no longer being worn, so that a clinician can engage in appropriate follow-up such as contacting the patient to inquire as to where the monitoring device 12 is located). In another example, the indication 26 can be used for patient compliance during clinical trials, medication valuations, and so forth.
In some embodiments, the clinical health information system 20 and/or the on-board electronic processor 16 can control operation of the accelerometer 14. For example, when the respiration rate and/or heart rate and/or activity values underrun the predetermined threshold, the accelerometer 14 can be deactivated, and thus prevented from acquiring additional accelerometer data 15 and, for example, saving battery life. When the respiration rate and/or heart rate and/or activity values exceed the predetermined threshold, the accelerometer 14 can be controlled to acquire additional accelerometer data 15.
In some examples, the monitoring device 12 is used to collect patient data to derive an accurate and reliable indication about the patient deterioration. The monitoring device 12 can be used for other purposes such as activity monitoring, stamina evaluation, functional capacity evaluation, and so forth. The monitoring device 12 is equipped with the accelerometer 14, with which body movements and physiological modalities are measured. Next to a characterization of patient deterioration or stability, this information can be used to detect whether or not the patient P is wearing the monitoring device 12. The number of steps per day or an aggregate indicator of body movement and posture in relation to physiological modalities like heart rate and respiration rate are examples of the wearability indicators obtained from the monitoring device 12. In addition, quality indicators on the measured vital signs can also give information about the monitoring device 12 being worn or not, as the underlying raw signals may be quite different if the monitoring device 12 is worn or not.
The clinical health information system 20 is configured to process wearability data and advise clinical practitioners on the appropriateness of responding and acting to any alarm or notification coming from the monitoring device 12. The clinical health information system 20 evaluates wearability and consequently notifies the hospital caregiver when a patient P is active but seems to be not wearing the monitoring device 12 anymore. The hospital caregiver can subsequently remove the patient P from their active surveillance database or contact the patient P if this is an unexpected removal of the monitoring device 12.
At an operation 50, a determination is made, for each time point in the accelerometer data 15, whether HRq and RRq are both valid. HRq and RRq are binary valued, indicating whether HR and RR measurements are valid or not. This is indicated by a value DV=1 if so, or DV=0) if either or both vitals are of too low quality. Act is represented as a discrete value on a scale from 0 (no activity) to 10 (high activity).
At an operation 52, a running average is taken over a predefined sliding window, of both the combined validity DV and the activity level Act, which can yield running averages DV_win and Act_win, respectively. The window size can, for example, be equal to 50 (or 60): 12 per hour, in some nonlimiting illustrative examples. This is minimally equal to 5 hours, in some nonlimiting illustrative embodiments. The window size is changeable, and a balance needs to be struck between being strict with all detection being true detections (high specificity) or being less strict with increased chance of false detection (high sensitivity).
At an operation 54, thresholds of DV_thr=0.3 and Act_thr=1 are applied, and a determination is made where both DV_win<DV_thr and Act_win<Act_thr. Here, the first 49 values of DV_win and Act_win can be discarded, as they are not based on a full window of, for example, 50 measurements yet (a run-in effect). Optionally, the first time points can be discarded until threshold DV_thr or threshold DV_Act is exceeded (or both), to ensure that we are passed a run-in period. The thresholds can be set differently for other sensors, pending the use case and sensor accuracy/sensitivity.
At an operation 56, at the time points where DV_win<DV_thr and Act_win<Act_thr, the determination is made as to whether the monitoring device 12 is not worn. The determination is made to conclude that the monitoring device 12 is not worn from the very first time point that this happens, as it typically cannot be re-applied.
In some embodiments, quality indicators of the vital signs may be determined, and this may be combined with the actual measurements to determine the moments when they are valid. Furthermore, the determination of whether the vital signs are valid may include the activity information, as well as other information such as posture info coming from the monitoring device 12.
In some embodiments, the wearing stop time point can be refined. For instance, it may be chosen to go back in time from the detected wearing stop time point (i.e., the dotted line in
The disclosure has been described with reference to the preferred embodiments. Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the exemplary embodiment be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.
| Number | Date | Country | Kind |
|---|---|---|---|
| 22208545.8 | Nov 2022 | EP | regional |
