MONITORING SYSTEM FOR CARE PROTOCOLS

Abstract

A monitoring system for care protocols, comprising sensors connected to electronic devices to input data from a patient, where sensors measure critical values from a patient; an interface for receiving data and allowing users to write and change process control in real time; a processor connected to the interface to receive input parameters, wherein the processor calculates output values based on the input parameters compared to the critical value to determine whether the output values are outside acceptable range; means for setting critical values, ranges of critical value, and alarm points when the critical values are outside of the range; where the interface receives critical patient parameters and the interface includes a manual input and a machine input from one or more sensors; and wherein the system calculates and monitors critical steps or values for a patient and enables the output values for monitoring or display, in real time.

Claims

1. A monitoring system for care protocols, wherein the system comprises: a plurality of sensors operably connected to electronic devices to input data from a patient to an interface, said sensors being disposed to measure critical values from a patient; an interface for receiving input data and allowing users to define process control limits and when appropriate change these limits of a process control in real time, as appropriate for the care of the specific patient; a means for authorized practitioners to formally document the decision to deviate from a medical facility defined protocol or the specific patient care plan; a processor operably connected to the interface to date stamp and receive, agnostically, data signals corresponding to received data input pertaining to one or more input parameters, wherein specific data values collected from the multiple data sources may be used in more than one output calculation formula, the processor calculates one or more output values based on the one or more input parameters and compares said output values to said critical values to determine in real time whether said output values are outside an acceptable range; and input means for setting critical values for a patient, ranges of critical value, and alarm points when the critical values are outside of the ranges by providing appropriate defined notifications/prompts and/or recommended actions in real time; said interface configured to receive data input pertaining to one or more input parameters selected from the group consisting of patient input parameters, perfusion input parameters, oxygen delivery input parameters, oxygen consumption input parameters, carbon dioxide production input parameters, narcotic input parameters, blood pressure input parameters, and other critical patient input parameters, and combinations thereof; wherein the interface includes a manual input for at least one or more input parameters by a user and a machine input configured to receive sensor-derived input from one or more sensors; and wherein the system is operable to perform one or more functions directed to calculating and monitoring critical steps or values for a patient and enables the output values for monitoring or for display, in real time, including the output values calculated by the processor, and the range of critical values.

2. A monitoring system for surgical operations comprising: a controller configured to: receive a hematocrit and/or hemoglobin value of a patient, receive a pump flow rate value, receive an arterial oxygen saturation value of the patient, calculate an indexed oxygen delivery value based on at least each of the arterial oxygen saturation value, the hematocrit and/or hemoglobin value, a body surface area of the patient, and the pump flow rate value, means to set a range for the delivery value, means to compare the calculated indexed oxygen delivery value against an indexed oxygen delivery value threshold, and trigger an alarm if the calculated indexed oxygen delivery value is outside of the range of delivery value; and an optional display operably coupled to the controller, the display configured to display: in a first window of the display, the calculated indexed oxygen delivery value, and in a plurality of windows positioned at least partially around the first window, values of physiological parameters of the patient and parameters of the monitoring system including the pump flow rate value.

3. The system according to claim 2, wherein the patient input parameters include a patient's height and the patient's weight, and the at least one patient morphology value includes a body surface area value for the patient.

4. The system according to claim 2, wherein the perfusion input parameters include a patient's pre-cardiac bypass blood volume per unit weight, the patient's pre-cardiac bypass hematocrit, a priming volume, and a prime-off volume.

5. The system according to claim 4, wherein the perfusion input parameters further include a hematocrit of packed red blood cells, a volume of a packed red blood cell infusion, and a volume of a fresh frozen plasma infusion and/or a volume expander infusion, and the at least one vascular fluids value includes an intra-cardiac bypass hematocrit value or an intra-cardiac bypass hemoglobin value.

6. The system according to claim 2, wherein the oxygen delivery input parameters include an SaO.sub.2 and a PaO.sub.2, and the oxygen consumption input parameters include an SvO.sub.2 and a PvO.sub.2.

7. The system according to claim 6, wherein at least one oxygen delivery value is a function of cardiac bypass pump flow, the SaO.sub.2 and the PaO.sub.2, and at least one oxygen consumption value is a function of the cardiac bypass pump flow, the SvO.sub.2, and the PvO.sub.2, and the processor also calculates a ratio of oxygen delivery (DO.sub.2) to oxygen consumption (VO.sub.2), or a ratio of indexed oxygen delivery (DO.sub.2i) to indexed oxygen consumption (VO.sub.2i), or both ratios.

8. The system according to claim 2, wherein the carbon dioxide production input parameters include an expired CO.sub.2 and a sweep gas flow (Qs) through an oxygenator of a heart-lung machine.

9. The system according to claim 2, wherein at least one carbon dioxide production value is a function of the expired CO.sub.2 and the sweep gas flow (Qs) through the oxygenator of the heart-lung machine, and the processor also calculates a ratio of oxygen delivery (DO.sub.2) to carbon dioxide production (VCO.sup.2), or a ratio of indexed oxygen delivery (DO.sub.2i) to indexed carbon dioxide production (VCO.sub.2i), or both the ratio of oxygen delivery (DO.sub.2) to carbon dioxide production (VCO.sub.2) and the ratio of indexed oxygen delivery (DO.sub.2i) to indexed carbon dioxide production (VCO.sub.2i).

10. The system of claim 1, further comprising a monitor display assembly operably connected to receive the one or more output values calculated by the processor, wherein the monitor display assembly includes a display configured for monitoring at least one of the one or more output values calculated by the processor, the range of the critical values, and the real time value of the output value.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0013] The foregoing and other features and advantages of the present invention will become apparent to those skilled in the art to which the present invention relates upon reading the following description with reference to the accompanying drawings, in which:

[0014] FIGS. 1-4 are front view of a monitoring device showing a screen displays of the patient's vitals, the hemodilution calculation, the protamine risk and vital settings, and the intra-Op Cockpit in normal state;

[0015] FIGS. 5-8 are front views of a monitoring device showing a screen display of the patient's vitals before, during and after an operation;

[0016] FIG. 9 is a front view of a monitoring device showing a screen display of the patient's vitals as part of a prescription compliance report; and

[0017] FIG. 10 is a front view of a monitoring device showing a screen display of the patient's vitals throughout an operation and presented in graphical form.

DETAILED DESCRIPTION OF THE INVENTION

[0018] The present invention is directed to a monitoring system for medical patient care protocols, such as surgical operations, that is capable of writing, operationalizing and providing feedback on any process control, in real time. To accomplish this the system is capable of collecting information from any number of electronic devices including medical devices and manual entries. The data is collected, time stamped at time of data collection, stored, translated to the appropriate machine language, transmitted to the data storage repository, using applicable calculation algorithm, and providing the required notification and/or prompt to the medical practitioner(s) requiring notification. The system performance allows this series of activities to be accomplished in milliseconds.

[0019] The monitoring system of the present invention comprises a plurality of sensors operably connected to electronic devices to input data from a patient to an interface for receiving input data and allowing users to write process controls and change elements of a process control in real time; a processor operably connected to the interface to receive data signals corresponding to the received data input pertaining to the one or more input parameters, wherein specific data values collected from the multiple data sources may be used in more than one output calculation formula.

[0020] The interface is configured to receive data input pertaining to one or more input parameters, including patient input parameters, perfusion input parameters, oxygen delivery input parameters, oxygen consumption input parameters, carbon dioxide production input parameters, narcotic input parameters, blood pressure input parameters, and other critical patient input parameters and the interface includes a manual input of at least one or more input parameters by a user and a machine input configured to receive sensor-derived input from one or more sensors; and wherein the system is operable to perform one or more functions directed to calculating and monitoring critical steps or values for a patient and enables the output values for monitoring or for display, in real time, including the output values calculated by the processor, and the range of critical values. The sensors are disposed to measure critical values from a patient

[0021] The system of the present invention includes means to connect to all medical devices to facilitate collection of data as fast as the devices can output data, means to integrate to any available health information system, including electronic health records, means to document and facilitate manual user input, means to leverage published simple computations to calculate clinician required values as needed, a processor operably connected to receive and process the collected data in real time, to execute clinician generated process controls, means to dynamically change documentation requirement to simplify and execute process control as needed, means for providing notifications, verifications, and guidance alerts, and monitor display means to allow users to see which process controls are operational, exceptions, alerts etc. and provide full visibility of what is going on in patient populations at all times and means for real time reporting.

[0022] The present invention is focused on the care giver defining the patient care plan (prescription) with or without the formulas. This is true regardless of the specific care plan or area. With the present invention the use of closed loop interoperability, which is known in the industry, is not required. With the present invention interoperability as defined by the industry and FDA is never required. The tool provides a means to control the processes and compliance with practitioner directed care without the limitations of medical device interoperability.

[0023] The processor calculates one or more output values based on the one or more input parameters and compares said output values to said critical value to determine in real time whether the output values are outside the acceptable range. The input means allows for setting critical values for a patient, ranges of critical value, and alarm points when the critical values are outside of the range by providing appropriate defined notifications and prompts and/or recommended actions in real time. These calculations are known in the industry and are made using formulas known in the industry and can be done using the processor. By comparison of the input and output values, it is determined that the output values are outside of the acceptable range.

[0024] The present invention provides a way to write, deploy and evaluate process controls in real time. The process controls will be clinician defined and can be editable on the fly. The process can include any interventions including medications or procedures and can also indicate clinical guidance that can be used to mitigate negative patient events. The present invention can span care areas and phases of care, can include multiple care teams, can provide clinical role specificity and manage hand-offs, such as transitions of care. The present invention will provide for exceptions/deviations from expected care and patient course to be viewable in real time. Thus, compliance reports available at defined times (e.g. case end) to “close loop”. The present invention incorporates mobile tools, such as smart phones, tables, etc., that augment clinical workflows.

[0025] The present invention is achieved by connecting disparate data sources (devices, electronic health records (EHR) etc.) so that process controls can be implemented and visualized in real time, providing a simple user interface (UI) for clinicians to write their own process controls, allowing clinicians to change elements of a process control in real time, allowing clinicians to indicate whether is process control is relevant in real time, sorting patients into risk groups or other categories in real time, matching groups of patients at risk/or patient categories with risk or group specific interventions, and incorporating decision support elements and documentation tools to dynamically indicate when specific interventions are due based on patient risk/categories to make it easy for clinicians who are executing the process control to understand when something is due proactively, and when something is past due. Thus, the present invention exposes compliance with a process control or deviation from expected course in real time by closing the loop in real time so that process improvement can occur.

[0026] The programed computer will receive data from various sources, such as medical devices for monitoring and/or treating a patient. Monitored data can comprise physiological data elements, video data elements, and audio data elements. Once the data is received, it is date stamped, and stored. The present invention allows the data to be collected agnostically. By agnostically, it is meant that the data is collected from various sources, equipment, instruments, and/or sensors without regard to the language in which it is transmitted, and/or is generalized so that it is interoperable among various systems. So, the system of the present invention does not require a match with the data source to be functional and can accommodate various data sources.

[0027] The data which may need to be translated or converted to the machine-language of the programed computer is translated. This means translating data received from any electronic source to the data storage language of the computer, and, in turn, translating from the data storage to the language of the receiving electronic source. This allows the hospital to utilize any number of suppliers and/or device models within the interoperability environment. This eliminates the need to buy new equipment just to achieve interoperability. The system will allow access to all relevant patient data from all applicable sources as discussed above and a means to store accurately, timely and completely all relevant data regarding patient care and patient response/outcome. If translation is unnecessary, the data is stored, preferably in a cloud storage, which provides remote access to the data. The data is then evaluated for the accuracy of the data and that is verified. In response to a request for data transfer to a target device, the applicable data is collected per the data mapping requirements. If data translation is needed for the target device, evaluation and translation are done. Then, the data is transmitted to the target device and the accuracy is verified.

[0028] As an example, data can be expressed in many machine-language instructions. Since there are many machine-languages, as is known in the art, each device and operating system functions in its chosen machine-language. The present invention senses the machine-language in which the data is presented and translates it into the machine-language employed by the present invention. The machine -language employed by the present invention is not critical and is one known in the art. So, it is only a matter of translating the machine-language of the data received to that which will function in the method and system of the present invention. In turn, when data is transmitted to an electronic source, it is translated into the machine-language of that source.

[0029] The present invention allows for the acquisition of data from multiple disparate sources, consolidation of all information within a unified view with all data time synchronized at time of collection, running process controls and workflows, and delivering actionable insights to specific users in real time, i.e., the actual time during which an event occurs. Since data is being acquired in real time, the time synchronization is required to accurately align the data from the various sources of information. The internal clocks of the various sources are not in agreement and may not be provided as part of the data provided by the device. Therefore, the need to synchronize the data to the time collected rather than use the various electronic source times, if available. This allows the data from multiple sources to be presented on the same screen. This allows for an accurate representation and display of the alignment of patient interaction with the patient's response, which is required for an informed assessment of patient response to patient care activities.

[0030] Data from various sources, including monitored data elements from any electronic device, such as medical devices for monitoring and/or treating a patient, can comprise physiological data elements, video data elements, and audio data elements. Once the data is received, it is date stamped, and stored. Data which is received may need to be translated or converted from the machine-language in which it is sent to the machine-language of the processor of the present invention. If the data which needs to be translated or converted to the machine-language of the processor of the present invention, is translated. If translation is unnecessary, the data is stored, preferably in a cloud storage, which provides remote access to the data. The data is then evaluated for the accuracy of the data and that is verified. In response to a request for data transfer to a target device, the applicable data is collected per the data mapping requirements. If data translation is needed for the target device, evaluation and translation are done. Then, the data is transmitted to the target device and the accuracy is verified.

[0031] The present invention provides an effective process control tool by requiring that real time data from multiple sources be collected so that the calculations can be done automatically and the calculated results can be compared to defined process control limits. When calculated values indicate that the value is not within specified ranges, the notification and prompt rules are activated, and appropriate individuals are made aware of the condition.

EXAMPLE

[0032] Converting a pre-incision brief during cardiac surgery into a process control that is dynamically executed in real time, with full transparency.

[0033] Traditionally, elements of patient's care during CPB are verbally discussed by Surgeon and Perfusionist during pre-incision brief. E.g. Surgeon instructs Perfusionist to maintain perfusion within certain settings including pump flow, hemoglobin and oxygen delivery/SV02. Surgeon has no ability to see perfusion course compared to desired goals while case in progress. Surgeon has no ability to evaluate perfusion course compared to goal in summary at case end.

[0034] With the present invention, the Perfusionist will enter all surgeon instructions into a mobile pre-incision briefing tool. The instructions will be converted to an advanced clinical guidance prescription in real time. The surgeon will have full visibility into compliance with the advanced clinical guidance prescription in real time while case in process. Surgeon will also be able to view compliance summary at the cases end in any format, including mobile.

Definitions and Abbreviations:

[0035] HCT: hematocrit (%) [0036] Hb: hemoglobin (g/dL) [0037] CPB: cardiopulmonary bypass [0038] T: temperature (° C.) [0039] VO.sub.2=oxygen consumption (mL/min) [0040] VO.sub.2i=oxygen consumption indexed (mL/min/m.sup.2) [0041] DO.sub.2=oxygen delivery (mL/min) [0042] DO.sub.2i=oxygen delivery indexed (mL/min/m.sup.2) [0043] O.sub.2 ER=oxygen extraction rate (%) [0044] VCO.sub.2=carbon dioxide production (mL/min) [0045] VCO.sub.2i=carbon dioxide production indexed (mL/min/m.sup.2) [0046] Ve=ventilation (L/min) [0047] eCO.sub.2=exhaled carbon dioxide (mmHg) [0048] AT=anaerobic threshold [0049] LAC=lactates [0050] Qc=cardiac output (mL/min) [0051] IC=cardiac index (Qc/m.sup.2), (mL/min/m.sup.2) [0052] Qp=pump flow (mL/min) [0053] IP=pump flow indexed (Qp/m.sup.2), (mL/min/m.sup.2) [0054] CaO.sub.2=arterial oxygen content (mL/dL) [0055] Cv O.sub.2=venous oxygen content (mL/dL) [0056] PaO.sub.2=arterial oxygen tension (mmHg) [0057] PvO.sub.2=venous oxygen tension (mmHg) [0058] a=arterial [0059] v=venous [0060] Sat=Hb saturation (%)

[0061] The following equations are applied to implement the monitoring system according to the invention:

VO.sub.2=Qc×(CaO.sub.2—CvO.sub.2) in a normal circulation   (1)

VO.sub.2=Qp×(Ca O.sub.2—CvO.sub.2) during CPB   (2)

DO.sub.2=Qc×CaO.sub.2 in a normal circulation   (3)

DO.sub.2=Qp×CaO.sub.2 during CPB   (4)

O.sub.2 ER=VO.sub.2/DO.sub.2(%)   (5)

Hb=HCT/3   (6)

CaO.sub.2=Hb×1.36×Sat(a)+PaO.sub.2×0.003   (7)

CvO.sub.2=Hb×1.36×Sat(v)+PvO.sub.2×0.003   (8)

VCO.sub.2=Ve×eCO.sub.2×1.15   (9)

[0062] The present system can be employed, for example, with a heart-lung machine, or as a cardiac bypass system, or as a cardiopulmonary bypass system, and which includes cardiopulmonary bypass (CPB) systems, minimal extracorporeal circulation (MECC) systems, extracorporeal membrane oxygenation (ECMO) systems (respiratory and cardiac), and pump assisted lung protection (PALP) systems) includes an oxygen delivery and consumption calculation-simulation-monitoring system, as well as a venous reservoir, a blood pump and an oxygenator. Such systems are well known and therefore have not been illustrated.

[0063] Such systems have blood sensors which measure blood oxygenation parameters SaO.sub.2, PaO.sub.2, etc., pertaining to the amount of oxygen carried by the blood. A flow meter may be provided to measure the flow rate of blood exiting the blood pump and to input blood flow rate data Qp to the calculation-simulation-monitoring system. A CO.sub.2 sensor or capnograph may capture exhaled carbon dioxide (expCO.sub.2) data which is continuously measured and input into the calculation-simulation-monitoring system. A hematocrit (HCT) sensor may be placed on the venous or arterial side of the blood flow circuit to measure deoxygenated blood flowing from the cavoatrial cannula. Alternatively, the HCT sensor may be a non-invasive hemoglobin (Hb) sensor. Either HCT data or Hb data can be continuously input to the monitoring system.

[0064] The monitoring system includes an interface comprising a manual interface portion and a machine interface portion. The interface is operably connected to provide data input to a programed processor, which employs the data in calculations of output values indicative of the patient's condition, or of output values simulating outcomes of hypothetical or planned clinical intervention. The processor is connected to a display assembly, which is used to display output values calculated by the processor, and to a memory assembly that is used to store output values and non-outputted values calculated by the processor. The memory assembly includes both RAM and ROM components, and/or other devices suitable for data storage. In accordance with an embodiment of this disclosure, processor is a general computer, but the processor may be an embedded system with particular dedicated functions (i.e., such as those described herein) within the larger electrical system of the calculation-simulation-monitoring system.

[0065] The manual interface portion is configured so that a user manually inputs data into user interface to populate the calculation-simulation-monitoring system. For example, certain data pertaining to a patient are substantially static data with respect to the cardiopulmonary bypass procedure to be performed. Examples of such static patient data includes patient morphological data such as height and weight, which will not substantially change during the cardiopulmonary bypass procedure. Such static data pertaining to the patient at the start of the cardiopulmonary bypass procedure may be referred to as patient input parameters. Thus, in accordance with this disclosure, static data constitutes data collected before, or at the beginning of a medical and/or surgical procedure and constitutes data that does not change appreciably during the course of the medical and/or surgical procedure.

[0066] Other static data that a user may input via the manual interface portion of the interface include perfusion input parameters such as the patient's pre-cardiac bypass blood volume per unit weight, and the patient's pre-cardiac bypass hematocrit. These perfusion input parameters pertain to the patient's starting condition at the beginning of the cardiopulmonary bypass procedure. While hematocrit, for instance, may change during the cardiopulmonary bypass procedure, its starting value at the beginning of the procedure does not. Consequently, it constitutes data that a user may input manually into the system via the manual interface portion.

[0067] As illustrated in the drawings, in FIG. 1 shows a method a clinician could use to enter a process control, such as, the data on a patient (e.g., height, weight, and age) into the system to define the controls that a clinician can apply to a healthcare process control. In this example, a pre-incision brief is shown. Next, as seen in FIG. 2, a simple calculation, such as, the hemodilution calculation algorithm is automatically performed based upon the patient data entered in FIG. 1. Clinicians can use data from multiple sources in a consolidated format as part of their process control. FIG. 2 shows an example of derived parameters (HCT) computed using a simple equation from parameters entered by clinicians as well as parameters imported from ancillary systems (TEG values) connected to this invention via interfacing. Then, as seen in FIG. 3, the clinicians can dynamically alter the threshold of a previously entered process control, such as setting the desired oxygen delivery components, as shown. The values continue to be displayed in the intra-Op Cockpit (i.e., the intra-operative information capture system of the anesthesia cockpit) in FIG. 4, in a normal state. FIGS. 3 & 4 are examples of parameters that can be used by clinicians to trigger a process control(s), and process control thresholds that can be dynamically altered by clinicians. FIGS. 3 and 4 show an example of parameters that can be checked by a clinician, and how various prescribed parameters of a process control to optimize oxygen delivery can be modified on the fly.

[0068] In FIGS. 5 and 6 are examples of how compliance to a process control can be viewed in real time at the point of care. The figures show how a process control to optimize oxygen delivery during bypass can be visualized on a perfusionist documentation tool. FIG. 6 shows intra-op cockpit in low Q state.

[0069] FIGS. 7, 8, 9, and 10 are examples of how a deviation from prescribed care within a process control point value can be identified and classified at the point of care. FIG. 7 shows values within prescribed control values in low Q state. FIGS. 8, 9, and 10 show a deviation of prescribed control can be shown in real time at the point of care. For example, a deviation from prescribed oxygen delivery is highlighted, along with a drill down view of additional information to be presented as defined by the process control. FIG. 8 shows a surgeon intra-op dashboard, and FIG. 9 shows a prescription compliance report.

[0070] FIG. 10 is an example of how aggregate compliance with a process control can be viewed at end of a care episode. In this example, perfusionist compliance with prescribed Oxygen Delivery, Pump Flow, Hemoglobin, and Mean Arterial Pressure are shown, along with additional information that quantifies non-compliance.

[0071] Although the invention has been presented by the example of the drawings, it is much broader. It is a tool that allows users to write, deploy and get feedback on process controls in real time. Targeted oxygen delivery for perfusion is just one example.

[0072] Although the invention has been described in detail with reference to particular examples and embodiments, the examples and embodiments contained herein are merely illustrative and are not an exhaustive list. Variations and modifications of the present invention will readily occur to those skilled in the art. The present invention includes all such modifications and equivalents. The claims alone are intended to set forth the limits of the present invention.