WO2025201998A1 - Clinical context-driven user preparation - Google Patents

Abstract

A clinical alert device (10) for timely communicating a user message protocol for preparing a user to operate a medical device (30) for addressing a medical condition. In operation, the clinical alert device (10) temporally monitors an impending probability indicator of the medical condition based on at least one clinical predictive parameter of the medical condition received in real-time from a patient monitor (20), and timely communicates the user message protocol based on the impending probability indicator of the medical condition.

Description

CLINICAL CONTEXT-DRIVEN USER PREPARATION

FIELD OF THE INVENTION

The present disclosure generally relates to user preparation for responding to an emergency. The present disclosure particularly relates to preparing a rescue personnel for responding to an emergency, such as, for example, a rescue personnel being physiologically prepared for performing defibrillation of an impending cardiac arrest.

BACKGROUND OF THE INVENTION

Sudden cardiac arrest (SCA) is an emergency condition, and it requires not only familiarity with the tools required for resuscitation but also requires operational preparation of a rescue volunteer operating an automated external defibrillator (AED). If the rescue volunteer is not prepared, then being unprepared can lead to delays and errors during defibrillation use, leading to poor outcomes. For a better preparation for cardiac resuscitation, it is important that a rescue volunteer is provided with a timely indication so that the rescue volunteer can get an opportunity to mentally and physically get prepared (e.g., get mentally ready, get familiarized with defibrillator device, its location and readiness). Secondly, it would be desirable to remove time consuming steps in AED operation to make workflow faster and efficient.

Furthermore, existing use of defibrillators by rescue professionals in hospitals also has a few preparation limitations. First, a lack of information about the likelihood of potential defibrillators usage event, which can be used to give the rescue professionals opportunity and time for preparing themselves to operate a defibrillator. Second, a lack of opportunity for a rescue professional to get familiarized with defibrillators just before emergency situation, which hampers psychological and physical preparation of rescue professionals. Third, a loss of valuable time in setting up the defibrillators (manual check in for readiness/ time taken by defibrillators for self-check is time consuming and labor-intensive procedure). Finally, a loss of valuable time before initiation of defibrillation due to difficulty in locating available defibrillators in timely manner and checking status of consumable such as availability of electrodes/pad and their expiry dates. More particularly, the typical steps during defibrillation to deliver appropriate shock therapy involve (1) switching on the AED, (2) self-check in of AED (manual or automated), (3) placing the pads on patient’s chest to deliver the shock, and (5) placing AED electrodes on chest AED analyzes patient’s electrocardiogram (ECG) to determine whether the patient might benefit from a shock (usually 3 to 5 seconds). This step is prone to artifacts as ECG signal will often contain an artifact that can interfere with the analysis. If a shock is required, the AED will charge and instruct the user to push the shock button to deliver a required shock.

During these steps valuable time can be saved if the user is knowledgeable and trained for an anticipated AED use and if AED's preparation has started earlier. For example, the selfcheck in step can be started earlier if some prior information regarding need of AED is indicated by some means. Similarly, ECG acquisition time can be shortened if ECG is made available to AED earlier. If AEDs algorithms have access to continuous ECG and clinical context it could be possible to shorten the time taken by AED to start shock therapy, which can also minimize impact of artifacts on therapy delivery decision. More efficient management of these steps can also help in a proper preparation of a user for emergency. For success of such method, it is important that this method works well within the existing clinical workflow without need of any additional tool or interventions.

SUMMARY OF THE INVENTION

The present disclosure may be embodied as a clinical alert device, a clinical alert system or a clinical alert method for timely communicating a user message protocol for preparing a user to operate a medical device for addressing a medical condition.

Various exemplary embodiments of a clinical alert device of the present disclosure encompass a non-transitory machine-readable storage medium encoded with instructions for execution by a processor timely communicating a user message protocol for preparing a user to operate a medical device for addressing a medical condition. The non-transitory machine- readable storage medium includes instructions to (1) temporally monitor an impending probability indicator of the medical condition based on clinical predictive parameter(s) of the medical condition received in real-time from a patient monitor; and (2) timely communicate the user message protocol based on the impending probability indicator of the medical condition. Various exemplary embodiments of a clinical alert system of the present disclosure encompass a patient monitor and a clinical alert device for timely communicating a user message protocol for preparing a user to operate a medical device for addressing a medical condition. The patient monitor is configured to monitor clinical predictive parameter(s) of the medical condition. The clinical alert device is configured to (1) temporally monitor an impending probability indicator of the medical condition based on clinical predictive parameter(s) of the medical condition received in real-time from the patient monitor, and (2) timely communicate the user message protocol based on the impending probability indicator of the medical condition.

Various exemplary embodiments of a clinical alert method of the present disclosure for timely communicating a user message protocol for preparing a user to operate a medical device for addressing a medical condition. The method encompasses (1) temporally monitoring, by a clinical alert device, an impending probability indicator of the medical condition based on clinical predictive parameter(s) of the medical condition received in real-time from a patient monitor, and (2) timely communicating, by the clinical alert device, the user message protocol based on the impending probability indicator of the medical condition.

The foregoing exemplary embodiments and other embodiments of the present disclosure as well as various structures and advantages of the present disclosure will become further apparent to those having ordinary skill in the art from the following detailed description of various embodiments of the present disclosure read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the present disclosure rather than limiting, the scope of the present disclosure being defined by the appended claims and equivalents thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will present in detail the following description of exemplary embodiments with reference to the following figures wherein:

FIG. 1 illustrates a first exemplary embodiment of a clinical alert system in accordance with the present disclosure;

FIGS. 2 A and 2B illustrate a first exemplary embodiment of a clinical alert method in accordance with the present disclosure; FIG. 3 illustrates a second exemplary embodiment of a clinical alert system in accordance with the present disclosure;

FIG. 4 illustrates a second exemplary embodiment of a user treatment preparation method in accordance with the present disclosure;

FIG. 5 illustrates a flowchart representative of an exemplary embodiment of an AED preparation method in accordance with the present disclosure; and

FIG. 6 illustrate a flowchart representative of an exemplary embodiment of an adapt alarm setting method in accordance with the present disclosure;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present disclosure describes clinical context-driven preparation devices, systems and methods for physiologically preparing volunteer personnel and medical personal in treating impending medical conditions. Such devices, systems and methods of the present disclosure encompass a monitoring of a probability of an impending medical condition based on clinical parameter(s) predictive of the medical condition and a preparation of a user operation of a medical device to treat the medical condition based on the probability of the impending medical condition (e.g., preparing or checking the preparations and readiness of the related devices that may be used on the patient).

For example, such devices, systems and methods of the present disclose may be directed to a probability of an impending cardiac arrest based on a monitoring of clinical parameter(s) predictive of cardiac arrest and a preparation for a user operation of the defibrillator based on the probability of the impending cardiac arrest.

By further example, such devices, systems and methods of the present disclose may be directed to a probability of an impending respiratory failure based on a monitoring of clinical parameter(s) predictive of respiratory failure conditions and a preparation for a user operation of a ventilator to treat respiratory failure based on the probability of the impending respiratory failure.

By further example, such devices, systems and methods of the present disclose may be directed to a probability of an impending neonatal complication based on a monitoring of clinical parameter(s) predictive of neonatal complication conditions and a preparation for a user operation of necessary systems/devices/tools to treat a neonatal complication based on the probability of the impending neonatal complication.

By further example, such devices, systems and methods of the present disclose may be directed to a probability of an impending emergency caesarean section based on a monitoring of clinical parameter(s) predictive of an emergency caesarean section conditions and a preparation for a user operation of necessary devices to treat an emergency caesarean section based on the impending probability of emergency caesarean section.

By further example, such devices, systems and methods of the present disclose may be directed to a probability of an impending shock based on ultrasound devices used in hemodynamic management for monitoring the heart to thereby understand the underlying reasons for a potential shock (e.g., the shock risk indication may have been triggered by a predictive algorithm monitoring the hemodynamic stability of the patient), and a preparation for a use operation necessary devices to threat the shock based on the impending probability of the shock. The probability for the impending shock may be alternatively or concurrently based on vital signs of the patients and/or electronic medical record data.

For purposes of describing and claiming the present disclosure, the terms related to the medical industry as provided herein broadly encompass definitions of these terms as known in the art of the present disclosure.

Also for purposes of describing and claiming the present disclosure, the term “user message protocol” broadly encompasses information that may be device driven, patient driven, and user (clinician) driven. Additionally, at different stages of a clinical alert method of the present disclosures, different types of information within a user message protocol may be presented, such as, for example, device driven information in the early stages of a clinical alert method of the present disclosure, clinician driven information in the middle stages of a clinical alert method of the present disclosure as risk of a medical condition increases, and patient driven information for the later stages of a clinical alert method of the present disclosure.

To facilitate an understanding of the present disclosure, the following description of FIG. 1-2B teaches an exemplary embodiments of clinical context-driven preparation devices, systems and methods in accordance with the present disclosure. From the description of FIGS. 1 and 2B, those having ordinary skill in the art of the present disclosure will appreciate how to apply the present disclosure to make and use additional embodiments of clinical context-driven preparation devices, systems and methods in accordance with the present disclosure.

Referring to FIG. 1, in operation, a clinical alert device 10a of the present disclosure monitors a probability of an impending medical condition based on clinical param eter(s) 21 predictive of a medical condition that are received from a patient monitor 20 as known in the art of the present disclosure or hereinafter conceived.

Further in operation, clinical alert device 10a of the present disclosure implements a preparation for a user operation of medical device 30 to treat the medical condition based on the impending probability of medical condition.

For example, in operation, clinical alert device 10a may monitor an impending probability of a cardiac arrest based on clinical param eter(s) 21 predictive of a cardiac arrest that are received from patient monitor 20, and clinical alert device 10a may further implement a preparation for a user operation of defibrillator to treat the impending cardiac arrest based on the impending probability of cardiac arrest.

In practice, a clinical personnel CP will interact 22 with patient monitor 20 and will interact 32 with medical device 30 as will be further described in the present disclosure.

Also in practice, device 10a may be a stand-alone device, installed in patient monitor 20, installed in medical device 20, installed in another device not shown in FIG. 1 (e.g., a tablet or a data collection device) or installed in a system not shown in FIG. 1 (e.g., a central monitoring station, an Electronic Medical Record (EMR) system, and a tele-monitoring system).

Also in practice, device 10a may have a structural configuration, as understood in the art of the present disclosure and as exemplary described in the present disclosure, of an application specific main board or an application specific integrated circuit for controlling an application of various inventive principles of the present disclosure as subsequently described in the present disclosure. The structural configuration of the device 10a may include, but is not limited to, processor(s), computer-usable/computer readable storage medium(s), an operating system, application module(s), peripheral device controller(s), slot(s) and port(s);

Also in practice, device 10a may be embodied as a module in the form of an electronic circuitry and/or executable program(s) (e.g., executable software stored on non-transitory computer readable medium(s) and/or firmware) for executing a specific application of various inventive principles of the present disclosure.

In one embodiment as shown in FIG. 1, device 10a employs a processor 11 and non- transitory machine-readable storage medium 12 encoded with instructions for execution by processor 11 of a clinical alert predictor 13 and a clinical alert communicator 14 in implementing an exemplary embodiment of a clinical-context defibrillation preparation method of the present disclosure represented by a flowchart 40 as shown in FIG. 2A and 2B.

For this method, patient monitor 20 collects clinical data of a patient, such as, for example, at a bedside of the patient predicative of a cardiac arrest of the patient, and will provide standard audio-visual indications of cardiac condition of a patient including any clinical alert messages 15 received form CAD 10a as will be further described in the present disclosure. Medical device 30a in the form of a defibrillator capable of wireless and/or wired communications with CAD 10a and executes a flowchart 70 as shown in FIG. 2A.

Referring to FIG. 2A and 2B, a stage S42 of flowchart 40 encompasses clinical alert predictor 13 implementing algorithms, as known in the art of the present disclosure or hereinafter conceived, for a continual generation or an intermittent generation of a probability of a cardiac arrest based on clinical data 21 received from patient monitor 20.

If, during a stage S44 of flowchart 40, a baseline impending probability of cardiac arrest PBCA is greater than a threshold Pi (e.g., Pl being 0.6), clinical alert communicator 14 will communicate a clinical alert preparation message to AED 30a including instructions for AED 30a to run-self assessment check during a stage S74 of flowchart 70 so that AED 30a is ready in advance for interventions, if required. The result of the self-assessment can be communicated back to CAD 10a and displayed on a graphical user interface of patient monitor 20. This way the user CP can be informed about AED’s readiness for upcoming resuscitation.

Thereafter, during a stage S50 of flowchart 40, clinical alert predicator 13 ascertains if a current impending probability of cardiac arrest PCCA is above a certain threshold P2 (e.g., 0.7) and/or if a current time predicted for cardiac arrest TCCA is less than a certain time threshold Ti (e.g., 5 minutes). If so, during a stage S52 of flowchart 50, clinical alert communicator 14 communicates a clinical alert interaction method including instructions for patient monitor 20 and AED 30 to instruct the user to get familiarized with AED. In practice, empirical data or retrospective data may be provided to establish and adjust these thresholds so that enough time is available for a user to interact with AED 30a prior to any cardiac arrest. The behavior (settings) of the prediction algorithm can be adjusted taking into account the user context and workflow information into account according to the expected available time (i.e., use workflow data to estimate the maximum time available to the user, and adapt the algorithm settings according to this maximum available time).

If a PM has location information about the AED, then same can be shared with the user as well.

Based on the probability of cardiac arrest and any time predicated for cardiac arrest, resuscitation flowcharts or checklists as well as related clinical protocols can be also displayed on PM for user guidance.

Timely notification to a user to get familiarized with AED or resuscitation procedure could be very helpful to prepare a user, as this offers the user a chance to get familiarized with device, its settings, and functional aspects (monophasic or biphasic defibrillator; appropriate charge to be delivered). This could be very useful from a psychological point of view to reduce emotional stress during actual resuscitation process later. Another benefit can be related to communication between users, because such information can be used also to increase the situational awareness of the other users (clinicians) in the environment, and this will help in improving the communication between different users. For example, since the users will be aware, the time of information communication can be shorter, without needing to first explain the context, etc.

The notification can be provided to the user who is closest to the patient, or an algorithm can be developed to select the most appropriate user for such situation by taking into account the schedule, location, education of different users and select the user that can make the intervention in the shortest time.

Once a user has interacted with the AED 30, a stage S78 of flowchart 70 involves AED 30a communicating a message of user interaction with AED 30 to CAD 10a whereby this information is then used by CAD 10a to generate future reminders related to cardiac arrest prediction and need of AED interaction. This information is also used to adapt sensitivity of future alarms or their snooze time. Moreover, the message receipt by CAD 10a of user interaction with the AED 30 indicates that user had a chance to get acquainted with AED 30 and has already checked its readiness. This also indicates that the user has better understanding of AED 30 and has already achieved at least a certain degree of psychological confidence regarding resuscitation process.

Referring to FIG. 2B, for user interaction of the AED 30 detected in a stage S54 of flowchart 50, stages S56 and S58 of flowchart will encompass delaying any future cardiac arrest prediction alarms after a time period DI (e.g., 5 minutes) if a delta between the current impending probability of cardiac arrest Pccvand the baseline probability of cardiac arrest PBCA IS less than a probability threshold P3 and/or if the current time predicted for cardiac arrest TCCA is greater than a certain time threshold T2. This is one example of algorithm behavior adaptation using user-related information.

Conversely, if user interaction of the AED is not detected in stage S54 of flowchart 50, stages S60 and S62 of flowchart will encompass delaying any future cardiac arrest prediction alarms after a time period D2 (e.g., 5 minutes) if a delta between the current impending probability of cardiac arrest Pccvand the baseline impending probability of cardiac arrest PBCA IS greater than a threshold P4 and/or if the current time predicted for cardiac arrest TCCA is less than a certain time threshold T3. Essentially, if it is found that probability of cardiac arrest has increased over a period of time, then these users will be reminded again to get familiarized with AEDs after time D2, otherwise the system will keep on monitoring the clinical parameters.

In a way, the information of users’ interactions with AED and clinical context are used to recommend further user actions and duration of reminders from cardiac arrest predication algorithms. In other words, the behavior (settings) of the cardiac arrest algorithm is determined also taking into account the prior information related to the nature of the algorithm output communicated to the user prior to the output generation by the algorithm.

For the execution of flowchart 70 or any other embodiment of a clinical alert method of the present disclosure, there are several considerations of the preparations of the AED device, clinician, and/or the patient for a potential cardiac arrest event.

More particularly, baseline impending probability of cardiac arrest Pbac being greater probability threshold Pl focuses on preparing/checking the device with no or minimal involvement of the clinician. Current impending probability of cardiac arrest Pcca being greater than probability threshold P2 and current time predicted for cardiac arrest Tcca being less than time threshold T1 focuses on preparing the clinician with information about how to use the device. Optionally, some patient specific information can be also provided. But at this point, the focus is on making sure that the clinician is aware of the device location, state, and how to use it.

If clinician has interacted with the device, or has consumed the information about how to use the device, then the content of the information can shift towards more patient specific aspects. And this information can be presented only after certain time has passed (time DI) since the clinician’s interaction with regard to the potential cardiac arrest event, or if the current impending probability of cardiac arrest Pcca has increased in comparison to baseline impending probability of cardiac arrest Pbca.

In other words, if a differential between current impending probability of cardiac arrest Pcca and baseline impending probability of cardiac arrest Pbca is less than probability threshold P3, then for time DI there is no information presented, and after time DI, the information that is presented is something new and extra on top of what has been communicated before. For example, this information can include some patient specific information which needs to be known to apply the defibrillator in the best way, or without any complications. In other words, the type of information that is presented as a result of knowing that the clinician has interacted with the device changes from device focused to patient focused information.

In the second case, where the clinician has not consumed the information generated as a result of current impending probability of cardiac arrest Pcca being greater than probability threshold P2 and current time predicted for cardiac arrest Tcca being less than time threshold Tl, the information is only presented when the differential between current impending probability of cardiac arrest Pcca and baseline impending probability of cardiac arrest Pbca is greater than probability threshold P4. The logic here is that the clinician was most probably busy or unavailable to consume the previous information, and the clinician needs to be bothered again if the trend of increased risk of cardiac arrest continues. In this case, when the information associated with a differential between current impending probability of cardiac arrest Pcca and baseline impending probability of cardiac arrest Pbca less than the time threshold TI, that information is communicated after time D2 (typically D2 will be zero here, not it can be also another value). Here the type of the information presented will include device related information that still needs to be consumed, and optionally it can also include some patient related information as well, because technically now the patient is closer a cardiac event. Also differently from the previous case, the way the alert is presented can also differ to emphasize the alert presence and to increase the likelihood that the clinician will consume and acknowledge the information presented.

As would be appreciated by those having ordinary skill in the art, depending on the timing of the generated alerts, and consumption of the information linked to the these events, the type of the new information presented to the clinician changes. Also the way these alerts appear on the PM can vary depending on what has been consumer or communicated before.

The information that can be communicated after Pcca>P2 & Tcca<Tl (or in general after Pbac>Pl) to the clinician can include, but is not limited to, (1) location of defibrillators: up to date exact locations, digital hospital maps, mobile applications for indoor tracking (which can be presented after Pbca>Pl), (2) availability and status: availability and operational status of the devices (which can be presented after Pbca>Pl), (3) instruction and protocols for device usage: quick access (links) to short manuals, step by step instruction, and (4) hospital specific emergency response protocols: relevant protocols, relevant people to contact, roles and responsibilities of different team members

Afterwards, patient specific information relevant to defibrillator application can be shown. This can include information about patients medical background, specific risk factors, etc. For example, such information can be (1) list of any current medications, especially the ones that may affect heart rhythm or can interact with the treatments in the cardiac resuscitation, such as beta-blockers, anticoagulants, antiarrhythmics, (2) list of any allergies to medications that may be used during cardiac arrest management, such as lidocaine, amiodarone, (3) a write up of any relevant lab results, such as electrolyte (potassium, magnesium) levels, blood gases, and troponin levels, (4) any current vital signs relevant for the cardiac arrest, (5) any medical history, family history, lifestyle factors: known heart conditions (e.g., coronary artery disease, heart failure, arrhythmias), previous cardiac arrest events, other relevant conditions (e.g., diabetes, hypertension), (6) any relevant lifestyle factors (smoking, genetic conditions), (7) a readout of any ECG data: historical ECGs segments that can show patients cardiac rhythm and arrhythmias, (8) a listing of implanted devices: such as pacemakers, implantable cardioverter-defibrillators (ICDs), including any information such as type, settings that may be relevant, and (9) any Do Not Resuscitate (DNR) Orders: Documentation of any advance directives, including DNR orders or other preferences for end-of-life care

Based on such information, the way AED is applied can vary. For example, for a patient with an implanted pacemaker, the defibrillator settings can be adjusted. For a patient that is receiving certain medications (anticoagulants and beta-blockers), the medications to be administered post-defibrillation can be chosen so that to avoid any medication-medication interactions.

Examples of clinician specific information that can be considered while determining the type, amount, and frequency of the information to be given to clinicians at different stages of suspecting cardiac event can include, but is not limited to, (1) training and certification status and history, (2) part performance and experience with emergency situations, past defibrillation usage, (3) any time spend with the information that is presented: how does the clinician use/ study/ consume the alert information, (4) emotional state, stress management history, etc, and (6) language and communication skills.

Referring to FIG. 3, medical device 30a is incapable of wireless/wired communication with CAD 10a For this embodiment, patient monitor 20 will exclusively communicate with CAD 10a and implement a flowchart 80 as shown in FIG. 4. Referring to FIG. 4, patient monitor 20 will generate audio-visual indication for user preparation during a stage S84 of flowchart 80 upon a receipt of a clinical alert preparation message and communicate test assessment of AED 30 being completed by the user.

Further, patient monitor 20 will generate audio-visual indication for user interaction/familiarity during a stage S88 of flowchart 80 upon a receipt of a clinical interaction message and communicate the user has been interacting with the AED.

FIG. 5 illustrates a flowchart 90 executable by AED 30a is directed to saving valuable time with the AED’s preparation by continuously sharing the information regarding one or all the patient in vicinity of the AED. The information can be gathered and shared using a patient monitor or device connectivity hub such as Capsule’s Axon or Neuron device. Electronic medical records (EMR) or Hospital information system (HIS) can be also used for this purpose. Referring to FIG. 5, a stage S92 of flowchart 90 encompasses a continual generation or an intermittent generation of a probability of a cardiac arrest based on information regarding relevant clinical parameters of all the patients near its vicinity. Alternatively, the cardiac arrest probability is calculated by the concern device and that information is shared with the AED.

When probability of cardiac arrest is beyond a certain threshold during a stage S94 of flowchart 90, the AED provides visual and audio indication of its location and information of a patient, who might need defibrillation in short time. Further, based on probability of cardiac arrest, AED can also run self-assessment check during a stage S98 of flowchart 90 to make sure that it is ready in advance. In case multiple patients require intervention, AED can also recommend nearby AED for procedure.

The present disclosure further provides a feedback loop between the alarm settings and user preparedness, taking into account context (environment) and device status, to react to the alarm. Based on this feedback loop, the alarm settings are adjusted to allow sufficient time for the user to get prepared for the actions necessitated by the alarm. More specifically this means first using alarm settings that allow longer user preparation time (probably at the expense of higher number of false positives), and later depending on the user readiness to act adjusting the alarm settings so that alarms are more accurate (i.e., less false positives), but probably at the expense of the user having now less time to react. In other words, if the user is ready to react and the device is prepared for operation, the alarms can be set in a manner to be more precise and accurate, while still allowing sufficient time to do the right intervention. On the other hand, if the users are not ready, then the alarms are adjusted so that they may sound earlier allowing users to accommodate and prepare properly.

Referring to FIG. 6, a stage S102 of a flowchart 100 has a first iteration. For this stage 102, first user information is received and this information is used to determine the minimum response time needed, according to which alarm settings are determined. When the alarm is triggered, the user is prepared with the first information. As a result of information presentation and consumption by the user, the user information is updated and second user information is received, according to which second response time and second alarm settings are determined. When alarm is triggered, the user need for additional information is evaluated and if necessary new information is provided. The process is repeated by updating the user information and further adapting the alarm settings.

The first information received from the user and the second information received from/about the user are of different nature. The first information is an indication of the experience level and (history of) trainings received by the user. The second information is combination of response of the user to the provided first information and any tasks expected to be performed by the use. Based on such the tasks, a current mental and physical state of the user may be predicted.

A stage SI 04 of flowchart 100, a response to the presented information is calculated directly based on the response of the user (e.g., questions asked to the user). The mental and physical load information is calculated based on workflow information where the time remaining in the current shift, as well as history of activities performed in the current shift (e.g., type of activities, number of interruptions) and activities to be performed in the future are considered. Additionally, the user information can be updated in a real time manner using workflow information, user location information, or user tracking information (e.g., via wearable devices, optimal means, or via speech). In addition (or instead of) the user information, device or context information can be used to set the first alarm and following settings. For instance, first device information (e.g., location, battery status, availability, additional tools needed) etc.) can be used to determine the minimum time needed to access and use the device and according to this the alarm settings can be determined. When alarm is triggered, the user can be provided with the device information (location, status, availability, additional tools needed such as patches) and device usage (procedure) information. As a result, the user may decide to improve the access to device and prepare required tools and environment to facilitate the device’s faster access and usage. If that is the case, the alarm setting can be updated based on this information to allow late, but more precise (fewer false positive) alarms.

The same also can be applied to the context information. For instance, the crowdedness and location of the current patient in the (ICU) ward can be taken into account to determine the response time in case of alarm and according to this alarm settings can be adjusted.

From the description of FIGS. 1-6 herein, those having ordinary skill in the art will appreciate the numerous benefits of the present disclosure including, but not limited to, provide integrated monitoring solution in acute care management to improve staff experience and improve patient outcomes.

The present 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 invention be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Further, as one having ordinary skill in the art shall appreciate in view of the teachings provided herein, features, elements, components, etc. disclosed and described in the present disclosure/specification and/or depicted in the appended Figures and/or recited in the Claims can be implemented in various combinations of hardware and software, and provide functions which may be combined in a single element or multiple elements. For example, the functions of the various features, elements, components, etc. shown/illustrated/depicted in the Figures and/or recited in the Claims can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software. When provided by a processor, the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared and/or multiplexed. Moreover, explicit use of the term “processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor (“DSP”) hardware, memory (e.g., read only memory (“ROM”) for storing software, random access memory (“RAM”), non-volatile storage, etc.) and virtually any means and/or machine (including hardware, software, firmware, combinations thereof, etc.) which is capable of (and/or configurable) to perform and/or control a process.

Moreover, all statements herein reciting principles, aspects, and exemplary embodiments of the present disclosure, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (e.g., any elements developed that can perform the same or substantially similar functionality, regardless of structure). Thus, for example, it will be appreciated by one having ordinary skill in the art in view of the teachings provided herein that any block diagrams presented herein can represent conceptual views of illustrative system components and/or circuitry embodying the principles of the invention. Similarly, one having ordinary skill in the art should appreciate in view of the teachings provided herein that any flow charts, flow diagrams and the like can represent various processes which can be substantially represented in computer readable storage media and so executed by a computer, processor or other device with processing capabilities, whether or not such computer or processor is explicitly shown.

Having described preferred and exemplary embodiments of the present disclosure, which embodiments are intended to be illustrative and not limiting, it is noted that modifications and variations can be made by persons having ordinary skill in the art in view of the teachings provided herein, including the appended Figures and claims. It is therefore to be understood that changes can be made in/to the preferred and exemplary embodiments of the present disclosure which are within the scope of the present disclosure and exemplary embodiments disclosed, described and taught herein.

Moreover, it is contemplated that corresponding and/or related systems incorporating and/or implementing the device or such as may be used/implemented in a device in accordance with the present disclosure are also contemplated and considered to be within the scope of the present disclosure. Further, corresponding and/or related method for manufacturing and/or using a device and/or system in accordance with the present disclosure are also contemplated and considered to be within the scope of the present disclosure.

Claims

Claims

1. A clinical alert device (10) for timely communicating a user message protocol for preparing a user to operate a medical device (30) to address a medical condition, the clinical alert device (10) comprising: a non-transitory machine-readable storage medium encoded with instructions for execution by at least one processor, the non-transitory machine-readable storage medium including instructions to: temporally monitor an impending probability indicator of the medical condition based on at least one clinical predictive parameter of the medical condition received in real-time from a patient monitor (20); and timely communicate the user message protocol based on the impending probability indicator of the medical condition.

2. The clinical alert device (10) of claim 1, wherein the instructions to temporally monitor the impending probability indicator of the medical condition based on the at least one clinical predictive parameter of the medical condition include a routine to: determine if a baseline impending probability of the medical condition is greater than a first probability threshold; and when the baseline impending probability of the medical condition is greater than the first probability threshold, proceeding to the instructions to timely communicate the user message protocol.

3. The clinical alert device (10) of claim 1, wherein the instructions to timely communicate the user message protocol based on the impending probability indicator of the medical condition includes a routine to: upon receipt, by the clinical alert device (10), of a communication informative of an operational preparation of the medical device (30), determine at least one of if a current impending probability of the medical condition is greater than a second probability threshold and if a current time predicted for an occurrence of the medical condition is less than a first time threshold; timely communicate a clinical alert interaction message when at least one of the current impending probability of the medical condition is greater than the second probability threshold and when the current time predicted for the occurrence of the medical condition is less than the first time threshold.

4. The clinical alert device (10) of claim 3, wherein the instructions to timely communicate the user message protocol based on the impending probability indicator of the medical condition includes the routine to: upon receipt, by the clinical alert device (10), of a communication of a user interaction with the medical device (30) or a communication of a user interaction with the information related to the medical device (30), determine at least one of if a delta between the current impending probability of the medical condition and the baseline impending probability of the medical condition is less than a third probability threshold and if the current time predicted for the occurrence of the medical condition is greater than a second time threshold; and timely communicate a clinical alert reminder message when at least one of the delta between the current impending probability of the medical condition and the baseline impending probability of the medical condition is less than the third probability threshold and the current time predicted for the occurrence of the medical condition is greater than the second time threshold.

5. The clinical alert device (10) of claim 3, wherein the instructions to timely communicate the user message protocol based on the impending probability indicator of the medical condition includes the routine to: upon receipt, by the clinical alert device (10), of a communication of a user interaction with the medical device (30) or a communication of a user interaction with the information related to the medical device (30), determine at least one of if a delta between the current impending probability of the medical condition and the baseline impending probability of the medical condition is greater than a fourth probability threshold and if the current time predicted for the occurrence of the medical condition is less than a third time threshold; and timely communicate a clinical alert reminder message when the delta between the current impending probability of the medical condition and the baseline impending probability of the medical condition is greater than the fourth probability threshold and the current time predicted for the occurrence of the medical condition is less than the third time threshold.

6. A clinical alert system for timely communicating a user message protocol for preparing a user to operate a medical device (30) for addressing a medical condition, the clinical alert system comprising: a patient monitor (20) configured to monitor at least one clinical predictive parameter of the medical condition; and a clinical alert device (10), wherein the clinical alert device (10) is configured to temporally monitor an impending probability indicator of the medical condition based on the at least one clinical predictive parameter of the medical condition received in real-time from the patient monitor (20); and wherein the clinical alert device (10) is configured to timely communicate the user message protocol based on the impending probability indicator of the medical condition.

7. The clinical alert system of claim 6, wherein the clinical alert device (10) being configured to temporally monitor the impending probability indicator of the medical condition based on the at least one clinical predictive parameter of the medical condition includes: the clinical alert device (10) configured to determine if a baseline impending probability of the medical condition is greater than a first probability threshold; and when the baseline impending probability of the medical condition is greater than the first probability threshold, the clinical alert device (10) configured to proceed to the instructions to timely communicate the user message protocol.

8. The clinical alert system of claim 6, wherein the clinical alert device (10) being configured to timely communicate the user message protocol based on the impending probability indicator of the medical condition includes: upon receipt, by the clinical alert device (10), of a communication informative of an operational preparation of the medical device (30), the clinical alert device (10) configured to determine at least one of if a first current impending probability of the medical condition is greater than a second probability threshold and if a current time period for an occurrence of the medical condition is less than a time threshold; and the clinical alert device (10) configured to timely communicate a clinical alert interaction message when at least one of the first current impending probability of the medical condition is greater than the second probability threshold and when the current time period for the occurrence of the medical condition is less than the time threshold.

9. The clinical alert system of claim 8, wherein the clinical alert device (10) being configured to timely communicate the user message protocol based on the impending probability indicator of the medical condition includes: upon receipt, by the clinical alert device (10), of a communication of a user interaction with the medical device (30) or a communication of a user interaction with the information related to the medical device (30), the clinical alert device (10) configured to determine at least one of if a delta between the current impending probability of the medical condition and the baseline impending probability of the medical condition is less than a third probability threshold and if the current time predicted for the occurrence of the medical condition is greater than a second time threshold; and the clinical alert device (10) configured to timely communicate a clinical alert reminder message when at least one of the delta between the current impending probability of the medical condition and the baseline impending probability of the medical condition is less than the third probability threshold and the current time predicted for the occurrence of the medical condition is greater than the second time threshold.

10. The clinical alert system of claim 8, wherein the clinical alert device (10) being configured to timely communicate the user message protocol based on the impending probability indicator of the medical condition includes: upon receipt, by the clinical alert device (10), of a communication of a user interaction with the medical device (30) or a communication of a user interaction with the information related to the medical device (30), the clinical alert device (10) configured to determine at lease one of if a delta between the current impending probability of the medical condition and the baseline impending probability of the medical condition is greater than a fourth probability threshold and if the current time predicted for the occurrence of the medical condition is less than a third time threshold; and the clinical alert device (10) configured to timely communicate a clinical alert reminder message when the delta between the current impending probability of the medical condition and the baseline impending probability of the medical condition is greater than the fourth probability threshold and the current time predicted for the occurrence of the medical condition is less than the second time threshold.

11. A clinical alert method for timely communicating a user message protocol for preparing a user to operate a medical device (30) for addressing a medical condition, the clinical alert method comprising: temporally monitoring, by a clinical alert device (10), an impending probability indicator of the medical condition based on at least one clinical predictive parameter of the medical condition received in real-time from a patient monitor (20); and timely communicating, by the clinical alert device (10), the user message protocol based on the impending probability indicator of the medical condition.

12. The method of claim 11, wherein the temporally monitoring, by the clinical alert device (10), of the impending probability indicator of the medical condition based on the at least one clinical predictive parameter of the medical condition includes: determining, by the clinical alert device (10), if a baseline impending probability of the medical condition is greater than a first probability threshold; and when the baseline impending probability of the medical condition is greater than the first probability threshold, proceeding to the timely communicating, by the clinical alert device (10), of the user message protocol.

13. The method of claim 11, wherein the timely communicating, by the clinical alert device (10), of the user message protocol based on the impending probability indicator of the medical condition includes: upon receipt, by the clinical alert device (10), of a communication informative of an operational preparation of the medical device (30), determining, by the clinical alert device (10), at least one of if a first current impending probability of the medical condition is greater than a second probability threshold and if a current time period for an occurrence of the medical condition is less than a time threshold; and timely communicating, by the clinical alert device (10), a clinical alert interaction message when at least one of the first current impending probability of the medical condition is greater than the second probability threshold and when the current time period for the occurrence of the medical condition is less than the time threshold.

14. The method of claim 13, wherein the timely communicating, by the clinical alert device (10), of the user message protocol based on the impending probability indicator of the medical condition further includes: upon receipt, by the clinical alert device (10), of a communication of a user interaction with the medical device (30) or a communication of a user interaction with the information related to the medical device (30), determining, by the clinical alert device (10), at least one of if a delta between the current impending probability of the medical condition and the baseline impending probability of the medical condition is less than a third probability threshold and if the current time predicted for the occurrence of the medical condition is greater than a second time threshold; and timely communicating, by the clinical alert device (10), a clinical alert reminder message when at least one of the delta between the current impending probability of the medical condition and the baseline impending probability of the medical condition is less than the third probability threshold and the current time predicted for the occurrence of the medical condition is greater than the second time threshold.

15. The method of claim 13, wherein the timely communicating, by the clinical alert device (10), of the user message protocol based on the impending probability indicator of the medical condition further includes: upon receipt, by the clinical alert device (10), of a communication of a user interaction with the medical device (30) or a communication of a user interaction with the information related to the medical device (30), determining, by the clinical alert device (10), at least one of if a delta between the current impending probability of the medical condition and the baseline impending probability of the medical condition is greater than a fourth probability threshold and if the current time predicted for the occurrence of the medical condition is less than a third time threshold; and timely communicating, by the clinical alert device (10), a clinical alert reminder message, when at least one of the delta between the current impending probability of the medical condition and the baseline impending probability of the medical condition is greater than the fourth probability threshold and the current time predicted for the occurrence of the medical condition is less than the third time threshold.