WO2014182677A1 - Système d'aide à la décision clinique en temps réel ayant des systèmes médicaux comme éléments d'affichage - Google Patents

Système d'aide à la décision clinique en temps réel ayant des systèmes médicaux comme éléments d'affichage Download PDF

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Publication number
WO2014182677A1
WO2014182677A1 PCT/US2014/036934 US2014036934W WO2014182677A1 WO 2014182677 A1 WO2014182677 A1 WO 2014182677A1 US 2014036934 W US2014036934 W US 2014036934W WO 2014182677 A1 WO2014182677 A1 WO 2014182677A1
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Prior art keywords
patient
display
medical
monitoring
decision support
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PCT/US2014/036934
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English (en)
Inventor
Kevin K. Tremper
Justin Adams
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The Regents Of The University Of Michigan
Alertwatch, Inc.
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Priority claimed from US13/887,646 external-priority patent/US9211096B2/en
Application filed by The Regents Of The University Of Michigan, Alertwatch, Inc. filed Critical The Regents Of The University Of Michigan
Publication of WO2014182677A1 publication Critical patent/WO2014182677A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A61B5/02055—Simultaneously evaluating both cardiovascular condition and temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
    • A61B5/744—Displaying an avatar, e.g. an animated cartoon character
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2505/00—Evaluating, monitoring or diagnosing in the context of a particular type of medical care
    • A61B2505/05—Surgical care
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
    • A61B5/7435—Displaying user selection data, e.g. icons in a graphical user interface
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/20—ICT specially adapted for the handling or processing of medical references relating to practices or guidelines

Definitions

  • the present disclosure relates to clinical decision support systems and, more particularly, relates to real-time clinical decision support systems capable of extracting data from medical history, current medical management, currently employed medical systems, and/or current physiological monitors and providing real-time alerts related thereto.
  • the present teachings also provide other intelligent indicia determined, gathered, calculated, or otherwise ascertain to provide warnings, alerts, signals, reminders, recommendations, or instructions to a caregiver in light of a plurality of data and known factors. That is, these data are not only presented, but also use real-time queries and calculations to enable caregivers to have the types of data that would traditionally assist them in patient care but only be available by reviewing the medical literature and/or doing retrospective individual calculations while providing patient care.
  • the principles of the present teachings enable additional factors, such as devices or implantables that interact with various organs within the patient body, to be actively monitored and considered in determining patient care.
  • these devices are not just passive monitoring physiologic signals, but are also actively interacting with the body or other biological system of the patient.
  • a cardiac bypass machine actively pumps blood through the cardiovascular system when the heart is stopped during specific operations.
  • a pacemaker could be implanted within a patient without its presence being immediately known.
  • the display system can comprise several general concepts.
  • the display can have readily identifiable icons for each of the vital organs— brain, lung, heart, kidneys, liver, skin, and the body— and also related medical systems— mechanical ventilators, pacemakers, and the like.
  • these readily identifiable icons can move in real-time with the input of real-time physiologic data and medical system operational conditions.
  • the heart beats in real-time with the patient's heartbeat provided by the physiologic monitor and the lungs expand and retract (ventilate) in real-time with the physiologic data provided from the monitoring system and anesthesia machine (airway pressures).
  • the icons can be color coded to signify the parameters are in various ranges, such as a normal range being depicted in the color green, a marginal range being depicted in the color yellow, and an abnormal range being depicted in the color red.
  • the icons can be color-coded orange (or any other indicia) if that organ system is at risk, given that patient's individual history that is associated with a specific risk for that organ. For example, if the patient has significant risk factors for postoperative myocardial infarction (heart attack) the rim around the heart can be the color orange alerting the caregiver that this patient is at risk.
  • the display system of the present teachings can provide pop-up alerts, or other alerts, when a combination of events occurs which produces a situation where there could be a possible important physiologic or medical system abnormality that could potentially cause risk or harm to the patient.
  • FIG. 1 is a schematic diagram and a screen capture image of a real-time visual alert display illustrating icons for the brain, tracheobronchial tree, lungs, heart, major vessels (aorta, vena cava), and body with temperature, hematocrit, and glucose with kidneys on either side each being indicated in a medium gray color (equivalent to the color green in the present figures) representative of all major organ systems being in their normal range.
  • FIG. 2 is a screen capture image similar to FIG. 1 illustrating a dark gray color (equivalent to the color red) outlining the heart icon and a lower right corner of the heart icon indicating that the alert display system detected ST segment changes consistent with possible ischemia of the myocardium.
  • FIG. 3A is a screen capture image similar to FIG. 1 illustrating a normal cardiac filling volume and also notes that the temperature is below the normal range, signified by the light gray color (equivalent to the color yellow), which is not yet in the seriously low range (which would be indicated by the color red on the temperature bar).
  • FIG. 3B is a screen capture image similar to FIG. 1 illustrating a low cardiac filling volume indicated by the dark gray color (red) in the heart icon.
  • FIG. 3C is a screen capture image similar to FIG. 1 illustrating a high cardiac filling volume indicated by the dark gray color (red) in the heart icon.
  • FIG. 4 is a screen capture image similar to FIG. 1 illustrating a light gray color (yellow) of the brain icon indicative of a light level of anesthesia/sedation with low probability of recall, but recall possible.
  • FIG. 5 is a screen capture image similar to FIG. 1 illustrating a dark gray color (red) of the brain icon indicating that the minimal alveolar concentration (MAC) for the anesthetic is less than the concentration expected to produce amnesia, therefore, the patient could potentially have awareness at this low level of anesthetic.
  • FIG. 6 is a screen capture image similar to FIG. 1 illustrating three abnormalities; specifically, the dark gray colored (red) "blood vessels" coming out of the heart icon demonstrate that the blood pressure is high; the dark gray color (red) Sp02 in the right lung demonstrates that the oxygen level is low; and at the same time the dark gray color (red) of the brain icon illustrates that the anesthetic concentration is low.
  • FIG. 7 is a screen capture image similar to FIG. 1 illustrating the abnormality of high airway pressures, showing the tracheobronchial tree in light gray color (yellow), such that the pressures ventilating the lungs are higher than normal, but not in the dangerous range.
  • FIG. 8 is a schematic of the real-time visual alert display system of the present teachings according to some embodiments.
  • FIG. 9 is a schematic of the real-time visual alert display system of the present teachings according to some embodiments.
  • FIG. 10 is a schematic of the real-time visual alert display system of the present teachings according to some embodiments.
  • FIG. 1 1 is a schematic of the real-time visual alert display system of the present teachings according to some embodiments.
  • FIG. 12 is a schematic of the real-time visual alert display system of the present teachings illustrating an alert setting forth pertinent links to relevant information according to some embodiments.
  • FIG. 13 is a schematic of the real-time visual alert display system of the present teachings according to some embodiments illustrating a body based indicia.
  • FIG. 14 is a schematic of the real-time visual alert display system of the present teachings according to some embodiments illustrating monitoring of skin/body issues.
  • FIG. 15 is a schematic of the real-time visual alert display system of the present teachings according to some embodiments illustrating monitoring of skin/body issues.
  • Example embodiments will now be described more fully with reference to the accompanying drawings. Example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well- known technologies are not described in detail.
  • the term "patient” is used to refer to an individual who is receiving medical care. It should be understood, however, that the term patient does not infer that the individual must be located in a hospital (e.g. intensive care unit, operating room, emergency department), doctor office, or other medical center.
  • the individual can be located in any location, such as any of the aforementioned locations and additionally in pre- hospital location (e.g. ambulance), extended care facility, nursing facility, home, or other care facility (both permanent and temporary). Accordingly, such individuals, for purposes of the present disclosure, are collectively referred to as a "patient” and such locations, for purposes of the present disclosure, are collectively referred to as "care facility”.
  • caregiver is used to refer to any individual who is administering or monitoring medical care of the patient. It should be understood, however, that the term caregiver should not be infer or interpreted to mean only certified medical caregivers, such as doctors, nurses, clinicians, practitioners, or medical specialists.
  • caregiver includes doctors, nurses, clinicians, practitioners, medical specialists, and various laypersons responsible for the treatment, monitoring, or medical response of the patient, including non-certified medical attendees (e.g. nursing home employees), family members, and others responsible for personal medical care of the patient. It should be understood that in some circumstances, the patient may be responsible for their own treatment and, thus, are included as a "caregiver". For purposes of the present disclosure, these individuals are collectively referred to as "caregivers”. GENERAL LAYOUT OF SCREEN.
  • a real-time visual clinical decision support system 10 is provided.
  • the real-time visual clinical decision support system 10 can comprise an alert display device 12 operably coupled to a plurality of sensors, probes, or other data collecting or monitoring devices 14.
  • the plurality of sensors 14 can be operable to be coupled to a patient and collect real-time physiologic data from the patient.
  • Alert display device 12 can comprise a control system or controller separate from or integrated therewith for assembling data from the plurality of sensors 14 for interpretation and/or display on alert display device 12, which will be described herein.
  • alert display device 12 can comprise one or more display layouts; however, generally, in some embodiments the clinical decision support system 10 comprises one or more icons, text, graphs, or other display indicia representative of the vital organs and/or major portions of a human body, such as brain, lung, heart, kidneys, liver, and the skin. In some embodiments, the clinical decision support system 10 can further comprise one or more icons, text, graphs, or other display indicia representative of other devices or implantables, such as pacemakers, implantable cardioverter-defibrillator (ICD), neural probes, intercranial pressure monitoring device, tracheal tubes, mechanical ventilator, kidney dialysis machines, cardiac bypass machine, or other device.
  • ICD implantable cardioverter-defibrillator
  • these devices or implantables can be either passive (e.g. merely monitoring a condition of the patient) or active (e.g. interacting with a system of the patient to effect a physiological or other response).
  • active e.g. interacting with a system of the patient to effect a physiological or other response.
  • additional parameters, organs, drugs, therapies, devices, implantable, or the like could be displayed.
  • these icons can be animated such that they move in real-time with the input of real-time physiologic data from the plurality of sensors 14 or otherwise display or confirm operation of a system, device, or implantable.
  • the icon used to depict the heart can beat in real-time with the patient's heartbeat provided by the physiologic monitor and the icon used to depict the lungs can expand and retract (ventilate) in real-time with the physiologic data provided from the monitoring system and ventilator (airway pressures).
  • the icon used to depict the implantable cardioverter-defibrillator can be animated in real-time, such as through the use of changing size, color, and/or shape, to illustrate operation of the implantable cardioverter-defibrillator.
  • the icons can be color coded to signify the parameters are in various ranges, such as a normal range being depicted in the color green, a marginal range being depicted in the color yellow, and an abnormal range being depicted in the color red.
  • additional color depictions can be used to indicate alert ranges or parameters. For example, in some embodiments, an alert color, such as orange, can be used to highlight an organ that has risk factors for or a history of organ dysfunction/damage.
  • the outline of the heart will be orange if the patient has a history of heart disease or a history of risk factors for heart disease.
  • the same is applied to other organ systems, i.e., the brain has a history of a stroke or risk factors for a stroke, the kidneys have a history of renal disease or risk factors for renal disease such as illustrated in FIG. 9.
  • additional color depictions or other indicators could show the current estimated interaction of that drug with a specific organ or organ system, or in another embodiment, the potential interaction of a drug and an organ could be depicted to help the caregiver predict the impact of the medical system.
  • FIG. 1 is a screen capture of the display, with all systems in the normal range.
  • the screen can comprise two or more sections 16 and 18.
  • the first section 16 can comprise pertinent patient history, such as the patient's name 20, registration number 22 , and location, followed by hours NPO 24 (that is, hours since the patient has taken fluids), estimated blood loss 26, and patient's weight 28.
  • the first section 16 can further comprise fluid assessments 30 (which will be covered in detail in the Heart Section under Cardiac Fluid) and an alert section 32, which in this case informs the provider that there are no glucose measurements for this patient or that the glucose needs to be rechecked.
  • first section 16 can comprise an alert reset button 34.
  • alert section 32 and reset button 34 can be set forth in a dedicated section 16'.
  • the second section 18 can comprise a series of icons as discussed herein.
  • the icons can be arranged such that at the top is the brain icon 40 having a tracheobronchial tree icon 42 extending there below connected to right and left lung icons 44, 46.
  • Centrally disposed is a heart icon 48 being fed from the left by the vena cava 50 and the output aortic arch 52 on the right going to the body 54 below.
  • the body icon or box 54 can comprise scales indicating temperature 56, hemoglobin 58, glucose 60, potassium, and INR (International Normalization Ratio).
  • INR International Normalization Ratio
  • alert display device 12 These icons and/or the overall layout of alert display device 12 are designed to be readily identifiable by a layman and/or healthcare professional.
  • real-time physiologic values can be provided to complement the associated icon.
  • the brain icon 40 can comprise a MAC level at 66 on the right which is the minimum alveolar concentration for anesthesia (will be discussed in the brain section), a BIS (Bispectral index) value at 68 on the left for measuring anesthetic depth.
  • BIS Breast index
  • peak airway pressures can be presented along with respiratory rate.
  • the outline of the lungs can illustrate the positive end expiratory pressure (PEEP).
  • each lung on the right is oxygenation with SpO2 (pulse oximeter arterial oxygen saturation) and on the left is carbon dioxide from the end tidal CO2.
  • the level can be green colored to indicate normal operation. That level in the heart icon 48 can go up and down with estimated intravascular volume, which is filling the heart, i.e. fluid resuscitation status.
  • the input of information being used to determine that fluid status level can be designated 70. This will be discussed in the cardiac section.
  • the systolic and diastolic blood pressure can be presented at 72. Those values relate to the color of the aortic arch 52 on the right of the heart icon 48.
  • a urine output measurement can be depicted below the right kidney at 74 and, in some embodiments, the patient's serum creatinine 76 (FIG. 8) can be depicted below the left kidney.
  • Each of the values within the body 54 are the temperature from the physiologic monitor; the hemoglobin/hematocrit either from the lab or an estimated value derived from the patient's last hemoglobin value, and blood loss and blood transfusion; and glucose, potassium, and INR, which are derived from the value from the lab.
  • each of the icons can be illustrated in one or more alert colors, such as green, yellow, red, orange, and the like. It should be recognized that in some embodiments the icons can be illustrated with one or more alert colors simultaneously, such as an orange alert color at the rear base portion of the brain icon (see FIG. 9). Still further, in some embodiments, a graphic or scale, such as scales 56, 58, 60, 68, and the like, can include a highlighted region surrounding the scale to bring such scale to the appropriate attention of a layman and/or healthcare provider (see FIG. 9). It should be appreciated, however, that variations can exist in terms of both color, shape, and/or pattern of these highlighted alerts without departing from the present teachings.
  • the brain icon 40 can be colored coded for assessing the level of anesthesia/consciousness.
  • the level of the anesthetic drug is constantly calculated by measuring the expired concentration of the inhaled anesthetics (vapor anesthetics: isoflurane, sevoflurane, desflurane, nitrous oxide) and intravenous anesthetics (propofol, dexmedetomidine, midazolam).
  • vapor anesthetics vapor anesthetics: isoflurane, sevoflurane, desflurane, nitrous oxide
  • intravenous anesthetics propofol, dexmedetomidine, midazolam
  • MAC minimum alveolar concentration for anesthesia
  • the estimation of a patient's level or depth of anesthesia is associated with its MAC level.
  • the brain icon 40 will turn colors when the MAC level reaches awake (red), borderline of awake and asleep (yellow), and when the brain is under anesthesia, that is, > .6 MAC or the MAC equivalent (green) (see FIGS. 2, 4, and 5).
  • a column labeled Bispectral Index (BIS) (or other similar brain function monitor, e.g. Entropy monitor) can be disposed adjacent brain icon 40.
  • the manufacturer of the device and the literature suggest that a BIS level between 60 and 40 is general anesthesia, above 60 may be light anesthesia, and between 80 and 100 the patient is most likely awake or lightly sedated. When this is less than 40, it is considered “too deep" of an anesthetic level and the brain icon will turn blue to designate too deep a level.
  • the BIS device is just an example of this type of EEG based brain activity monitor which provides input data to the brain icon.
  • a real-time calculated MAC value displayed at reference 66.
  • This MAC value which also provides a method to quantify a level of sedation, can be coupled with the BIS column to assess the level of anesthesia. Although these levels frequently agree, it is often up to the caregiver to determine which method, or the combination of methods, will be used in adjusting their anesthetic level. During anesthesia, if the MAC level drops to a range where the patient may be aware, the brain icon 40 will change color and a pop-up alert will say "awareness alert.”
  • risk factors for patients developing stroke in the perioperative period are also risk factors. These risk factors are derived from large studies of patients undergoing surgical procedures. If the patient has this constellation of risk factors, as mentioned herein, a small portion at the top of the brain icon will be colored orange, indicating this patient is at risk of perioperative stroke or if the patient has had a stroke.
  • an endotracheal tube is placed through the vocal cords into the trachea. That tube is then connected to a mechanical ventilator. This is required for most general anesthetics and whenever a patient requires ventilator support in the ICU. Placing this tube in the trachea is called endotracheal intubation. Generally, this is done when a patient has been given a sedative hypnotic, such as Propofol, and most frequently followed by a neuromuscular blocking agent, which paralyzes the muscles and enables the anesthesiologist or anesthesia provider or intensivist to intubate the patient with a device called a laryngoscope.
  • a sedative hypnotic such as Propofol
  • an icon 80 (FIG. 1 1 ) of an endotracheal tube placed in the airway will be colored orange if the risk factors are present for a potential difficult airway, and it will be red if the patient has a history of a known difficult airway.
  • the trachea splits into two, the right and left main stem bronchi which enter the right and left lung.
  • the right and left main stem bronchi will be green when the airway pressures during mechanical ventilation are in the normal range, turn yellow when they are slightly elevated, and turn red when they are abnormally elevated (see FIG. 7). All these ranges are configurable. This information is provided continuously from the ventilator. If the patient has a history of reactive airway disease (asthma or chronic obstructive pulmonary disease) which may result in bronchospasm, the outline of the trachea 82 (FIG. 1 1 ) will be the color orange (signifying potential for bronchospasm).
  • the right and left lungs are depicted on either side of the heart.
  • the lungs have an outline which expands and contracts with ventilation, that is, they expand during inspiration when the pressure goes up ventilating the lungs and they retract when the pressure goes down.
  • These data are provided continuously from the ventilator data and move in real-time with the patient's breathing.
  • the outline of each lung changes color with the level of PEEP. Acute increases in PEEP may represent a ventilator malfunction or tension pneumothorax.
  • a column 84 (FIG. 10) that shows arterial hemoglobin saturation from the pulse oximeter, which is the oxygenation of the arterial blood
  • in the left lung is a column 86 (FIG.
  • the icon or other indicia can indicate such condition through a filling level. This can help to identify organ-specific diseases that may not be obvious to a caregiver.
  • the heart icon 48 which has several functions, including depicting the heartbeat.
  • the heart icon 48 beats (contracts) with the heartbeat of the patient so there is a real-time assessment of the heart rate.
  • a filling level in the middle of the heart icon 48 is normal (green), a low level (red), and a high level (red) (see FIGS. 3A, 3B, and 3C). That is, there are ranges where the heart does not have enough fluid (dehydrated) and ranges where the heart is overfull (cardiac failure).
  • the information to calculate this level is provided from several aspects depending on the available data.
  • the estimate of fluid resuscitation uses standard rules of fluid replacement provided from the literature (generally known is the 4:2:1 rule for obligate fluid loss), also the time that the patient has been without fluid intake (the NPO time) times the obligate fluid loss of a standard patient based on their weight.
  • the data from the anesthesia information system are retrieved which provides the amount of fluid the patient has been given and the type of fluid. That is, whether they have received a crystalloid solution like normal saline or lactated ringers, or a colloid solution such as albumin, or a blood or a blood product.
  • the calculation also takes into account the estimated blood loss which is entered into the anesthesia information system.
  • the system automatically calculates in a balance of fluid inputs and outputs to estimate the adequacy of fluid resuscitation during the procedure.
  • this clinical process of calculating fluid needs is also dependent on the degree of surgical trauma (sometimes referred to as third- space losses)
  • the present teachings provide several options for selecting these third-space losses in the first section 16. The three selections on the third-space losses are to be selected by the anesthesia provider depending on the type of surgical procedure (minor procedures with little surgical trauma are light, moderate procedures are moderate, and procedures with large incisions and more tissue manipulation are severe). Each one of these will automatically use a different calculation to determine the needs of fluid during the surgical procedure (these specific losses for three types of surgical trauma are configurable).
  • the normalize button 90 allows the provider to "renormalize" the volume icon. That is, if the provider feels that the intravascular volume of the patient at any point in time is where they want them to be they can hit the "normalize volume” icon and it will move the icon fluid level up to the green level in the middle of the heart and then restart a new calculation from that point in time. If this normalization button has been used a star will be placed beside it to alert other providers and to remind the provider that they have renormalized the volume in that patient.
  • SPV systolic pressure variation
  • PPI pulse pressure index
  • CVP central venous pressure
  • the physiologic monitors of the EKG can continuously measure changes in the EKG associated with ischemia of the heart (ST segment changes). If these ischemic ST segment changes are noted during the case then the icon will also turn red and a pop-up of "possible ischemia" will be presented, Figure 2.
  • ST segment changes changes in the EKG associated with ischemia of the heart
  • the icon will also turn red and a pop-up of "possible ischemia" will be presented, Figure 2.
  • the intraoperative hemodynamic changes, blood pressure and heart rate which are associated with postoperative myocardial infarctions would be impractical if not impossible to do in real-time for they are calculated as a median blood pressure decreases more than 40% from their baseline blood pressure (in the preop area). This type of calculation could not be done by a caregiver in real-time; therefore this computer allows such complex calculations to happen in real-time on a rolling average to alert for situations that put the patient at risk.
  • an aortic arch rises and falls down to the body.
  • This aortic arch represents the aorta and the real-time blood pressure.
  • SBP which is the systolic blood pressure
  • the aorta will change color from green to yellow to red as the blood pressure drops or elevates into abnormal levels, Figure 6.
  • MAP mean arterial pressure
  • the alert may display (color of the aorta change) when an individual patient's SBP drops below 60% of their preoperative SBP.
  • the control system of the present teachings includes an algorithm that predicts future low blood pressure.
  • the present device takes the blood pressure over time and uses that along with the inspired anesthetic level to predict potential low blood pressure in the immediate future (in the next 3-5 minutes).
  • potential abnormal blood pressure is predicted a pop-up alert will be displayed to the provider. More specifically, the system monitors changes in SBP. If the predicted SBP in the next time interval (e.g., 4-5 minutes) is predicted (using a linear prediction) to be less than 50 mmHg (configurable), the system then looks to see if the inspired anesthetic agent concentration has decreased (this decrease in agent concentration shows that the anesthesia provider has noted the decrease in SBP and has taken the appropriate action of decreasing the anesthetic dose).
  • the system alerts to the potential of hypertension. It should be understood that this same principle of predicting future physiological status, based on the presence or lack of some type of medical intervention or event, can apply to additional monitoring signals, test results, or other measured data.
  • the rectangle below the heart has several variables being presented. On the left is body temperature 56 which comes from the physiologic monitor, in the center is hematocrit/hemoglobin 88 (FIG. 1 1 ) which comes from the lab (or an estimate described herein) and on the right is the glucose value 60 which comes from the laboratory. Below the glucose it will present the numerical value and the time since this measure was last determined. The same will be done for hematocrit, the time since the last measurement will be presented, that is, in minutes, hours and days. Another column for estimated hematocrit 90 (FIG.
  • INR Potassium
  • INR International Normalization Ratio
  • alert display 12 of clinical decision support system 10 can specifically depict the skin and/or body 130 of the patient. In this way, the skin and/or body condition can be assessed and monitored by a caregiver. In some embodiments, the front and back of the body can be illustrated to provide a complete log of skin/body condition.
  • clinical decision support system 10 enables improved treatment of skin issues in several significant ways. First, by asking a series of basic questions, it allows someone not skilled in the art of wound management to stage or evaluate the skin condition correctly. Second, users can employ clinical decision support system 10 to track and record the skin issue and associated location on the body.
  • clinical decision support system 10 can aid in providing a system to provide complete monitoring and analysis of many factors that influence patient care. Therefore, when integrated into the clinical decision support system, reminders, alerts, or other prompts can help facilitate specific types of care to target specific skin issues, and can also be evaluated alongside any contraindications by leveraging the other available data.
  • kidneys On either side of the body are icons 62 representing the kidneys. Under the right kidney will be the urine output 100 (FIG. 1 1 ), if available, provided in mis, mis/minute and mls/kg of body weight/minute. These different measurements of urine flow are of use to the provider.
  • urine output 100 FIG. 1 1
  • the laboratory value of creatinine 76 On the left side below the kidney is the laboratory value of creatinine 76, which is a measure of renal function. These values of creatinine along with glucose and hemoglobin are retrieved automatically from the hospital's laboratory system. If the patient's history suggests that the patient is at risk of postoperative renal failure, then the outer edge of the kidney icon will be the color orange.
  • various medical systems can be monitored, illustrated, animated, and/or considered in connection with operation of clinical decision support system 10.
  • these medical systems include any device or introduced influence that interacts with a biological system of the patient to monitor a condition of the patient or affect a physiological response in the patient.
  • the medical systems can comprise various medical devices and implantables such as, but not limited to, pacemakers, implantable cardioverter-defibrillators (ICD), neural probes, intercranial pressure monitoring devices, tracheal tubes, mechanical ventilators, kidney dialysis machines, cardiac bypass machines, or other devices that are passive (e.g. merely monitoring a condition of the patient) or active (e.g.
  • the medical systems can comprise various medications, therapies, or influencing technologies such as, but not limited to, drugs, medicines, medications, therapies, protocols, or techniques. These devices or introduced influences will collectively and interchangeably be referred to as "medical systems”.
  • these medical systems can be monitored, such as via a medical system detector, to obtain a monitoring signal or other status representative of the operation of the medical system.
  • the medical system detector can comprise a reader or transmitter for communicating the status of the medical system.
  • the medical system detector can be incorporated into the medical system to be an integral part thereof or can be a separate device.
  • the medical system detector may be unnecessary if a status signal or operational signal is unnecessary in order to ascertain the status of the medical system.
  • This monitoring signal or other status can be considered by the controller to produce or generate a corresponding display signal based on the monitoring system. Consequently, the display signal can be used to illustrate and/or animate medical system icons 108 (FIGS.
  • These medical system icons 108 can be shaped to be readily-identifiable medical systems by a caregiver, such as, for example, an endotracheal tube icon 80 (FIG. 1 1 ) being schematically-shaped as an endotracheal tube.
  • an implantable cardioverter-defibrillator (ICD) can be illustrated as an implantable cardioverter- defibrillator (ICD) icon 1 10 (FIG. 1 1 ).
  • ICD implantable cardioverter-defibrillator
  • ICD implantable cardioverter- defibrillator
  • These medical system icons 108 can be placed or displayed near the organ system with which the medical system is associated. For example, an intercranial pressure monitoring device icon can be displayed alongside the readily identifiable representation of the brain 40.
  • a cardiac bypass icon can be place adjacent heart icon 48 and a kidney dialysis machine icon can be placed adjacent kidney icon 62.
  • the relevant associated data, graphs, or other indicia associated with the medical system can be positioned adjacent medical system icons 108.
  • the operational status of the medical system can be illustrated in association with medical system icons 108.
  • operational status of the pacemaker device can be illustrated, such as on, off, error, or other state.
  • These status determinations can be illustrated using an associated color (e.g. green, yellow, red, orange) or other graphic and/or message.
  • alert or other messages to a caregiver can be provided based on the detected, calculated, or otherwise known status of the medical system. That is, a secondary parameter can be used to alert a caregiver when the state of the medical system can be varied to promote patient treatment.
  • a secondary parameter can be used to alert a caregiver when the state of the medical system can be varied to promote patient treatment.
  • an alert can be given to remind or urge a caregiver to restart a pacemaker after the pacemaker was turned off during a cardiovascular procedure.
  • an alert can be given to remind or urge a caregiver to stop a pacemaker prior to initiating a cardiovascular procedure. This alert can ensure that the medical system is placed in an appropriate condition during subsequent treatment.
  • clinical documentation can include a wide variety of resources, such as journal articles, presentations, dictionaries, textbooks, clinical references, protocols, guidelines, testing procedures, training materials, technical manuals, medical system manuals, trends, clinical analyses, database queries and the like.
  • clinical decision support system 10 of the present teachings enables automated access to clinical documentation during treatment through on-screen alerts, reminders, and links directly to the relevant clinical documentation.
  • the display of such relevant clinical documentation can be prioritized or otherwise sorted according to a predetermined metric, such as, but not limited to, the overall relevancy to the treatment being given, the source from which the relevant clinical documentation was obtained, the time-criticality of the necessary caregiving response, or other suitable weighting system.
  • clinical decision support system 10 can comprise alert window or other display indicia 1 16.
  • Alert window 1 16 can display a plurality of clinical documentation associated with a detected, determined, or calculated risk factor or other condition related to patient treatment.
  • the risk factor can be detected by any one of the plurality of sensors 14.
  • sensor 14 can output a signal indicative of a detected physiological condition of the patient, such as high blood pressure.
  • the risk factor can be determined by the controller in response to one or more detected or known conditions of the patient, medical system or other measured or calculated parameter.
  • the risk factor can be calculated based on one or more detected or known conditions of the patient, medical system, or other measured parameters.
  • a risk factor alert can be displayed using alert window 1 16.
  • Alert window 1 16 can display one or more clinical documentation(s) 1 18 related to the risk factor.
  • clinical documentation 1 18 can include any relevant clinical reference, protocol and/or guideline relating to the now-known risk factor or condition.
  • the alert display system 10 can automatically query a database or other repository of references (e.g. Internet) to link to the clinical documentation.
  • a database or other repository of references e.g. Internet
  • an alert such as alert window 1 16, or other indicia, such as a warning, icon, or animation
  • clinical documentation can be provided that relate to kidney or renal management when monitoring a patient having renal failure and/or whom is currently being treated by a kidney dialysis medical system.
  • a listing of clinical documentations can be produced upon request by the caregiver in addition to automatic depiction of references.
  • the request for a listing of clinical documentation relating to a particular organ and/or condition can be produced by clicking on the related icon on alert display system 10 or other input button. To this end, clicking on the related icon can generate alert window 1 16 containing the relevant clinical documentation.
  • alert window 1 16 need not be readily identifiable as an organ. That is, a graph or value indicating a specific lab value or monitor value could tie to an associated reference.
  • the pain button could include clinical documentation for managing pain as well as trending information on the patient's pain score. In some embodiments, the clinical documentation could change depending on the current status of the patient.
  • alert window 1 16 can be generated in response to a particular organ or medical system being monitored during the course of patient treatment.
  • the listing of clinical documentation could relate to the specific model of pacemaker that is implanted in the patient. Therefore, clinical documentation 1 18 can be automatically related to specific manufacturers, models, statuses of a medical system, or patient procedures.
  • alert window 1 16, and corresponding clinical documentation can be generated in response to the location of the patient in the hospital, the specific patient care protocol being employed, and/or the specific type of caregiver providing patient treatment. That is, for example, if a patient is located in an operating room, the caregiver may be provided with relevant anesthetic management documents for awareness. If the patient is located in an emergency room, the caregiver may be provided with relevant ischemic stroke documents. Moreover, use of contextual information regarding the patient, the diagnosis, and monitoring data could drive ongoing and dynamic production of references.
  • the present teachings can include various rules requiring input data from various parts of the patient's electronic medical record; history and physical, home medications, live physiologic data, and anesthesia information system data.
  • the basic system can provide information based on clinical rules of management that are part of the current training in Anesthesiology.
  • An example of such a rule is the rule that determines the filling level of the heart. This fluid level in the heart which either shows a low level in red, a normal level in green, and a high level in red is based on a calculation of fluid inputs and outputs of the patient.
  • the inputs are intravenous fluids of various types, including blood.
  • the outputs are obligate fluid loss due to metabolism and ventilation of vapor, as well as, blood loss, urine output, and surgical trauma. These rules are based on published literature from anesthesia textbooks. This type of basic rule as an alert for "Out of Normal Range," which is based on general training in Anesthesiology, can be configured by the caregiver if desired.
  • This second, more complex, rule is based on published literature regarding risk factors for certain adverse outcomes for the surgical procedure, e.g. having a postoperative myocardial infarction (heart attack).
  • the patients come to the operating room with a series of co-morbidities (other medical diseases) which put them at higher risk for having a myocardial infarction in the perioperative period, e.g. a history of diabetes, history of a previous heart attack, cerebral vascular or renal disease. If a patient has several of these risk factors they are in a higher risk group and based on published literature this rule in the display system will alert the caregiver of the organ at risk.
  • the present teachings can be used for the detection of the disease Malignant Hyperthermia and Malignant Neuroleptic Syndrome during anesthesia.
  • Malignant Hyperthermia is a rare, but life-threatening disease that occurs under general anesthesia when a patient is exposed to the muscle relaxant succinylcholine and/or a potent halogenated vapor anesthetic, e.g. isoflurane, sevoflurane, desflurane.
  • a potent halogenated vapor anesthetic e.g. isoflurane, sevoflurane, desflurane.
  • This is a genetic disorder which is autosomal dominant with a mixed penetrance that involves an abnormality of the ryanodine receptor in the muscle. It causes uncontrolled release of calcium and results in a severe metabolic crisis.
  • Malignant Neuroleptic Syndrome has the same clinical signs, symptoms, and treatment. It also occurs under anesthesia.
  • the present teachings use the simultaneous collection of data from anesthesia machine and an anesthesia information system and monitors to identify the onset of malignant hyperthermia to allow early detection and treatment. If treated early with the drug Dantrolene the disease has a very good outcome.
  • the present teachings in some embodiments, requires electronic data from an anesthesia machine, more specifically, end expired carbon dioxide measurements, inspired carbon dioxide measurements, minute ventilation (respiratory volume times respiratory rate), and with or without the patient's weight.
  • Malignant Hyperthermia alert will be activated:
  • End expired carbon dioxide increases at a rate greater than 1 .5 mmHg/min. (which is configurable) while, simultaneously the minute ventilation (expired tidal volume X respiratory rate) remains at 80% of the normal level (80 cc/kg/min. (which is configurable)) or greater and, the inspired carbon dioxide level remains less than 2 mmHg * and is not increasing.
  • a diagnosis of Malignant Hyperthermia can be diagnosed when the end expired C02 is rising steadily in the presence of no increase in inspired C0 2 and a normal minute ventilation. If all of these three events occur during anesthesia, it is diagnostic of Malignant Hyperthermia.
  • the present teachings can be used for the detection of Tension Pneumothorax.
  • a tension pneumothorax is an acute hemodynamic emergency where the air is trapped in a thoracic cavity producing high pressure which prevents blood from returning to the chest and right heart causing a life-threatening reduction in cardiac blood flow and blood pressure. This only occurs in patients receiving positive pressure ventilation either during anesthesia in the operating room or being ventilated in intensive care or other ventilator unit. For this alarm to be utilized it requires electronic capture of blood pressure data and inspired and end expired pressure ventilator data. These data are available when there are anesthesia information systems or critical care information systems in place. [0095] In some embodiments, the present teachings use the simultaneous collection of data to detect the occurrence of three events diagnostic of a Tension Pneumothorax:
  • Elevated end expired ventilator pressures greater than 15 mmHg (which is configurable) and increasing.
  • numeric thresholds and/or conditions can be configurable and/or eliminated in some embodiments. It should be noted that variations in display parameters, indicia, and threshold values are configurable. The present teachings can be used beyond the enumerated embodiment.

Abstract

L'invention concerne un système d'aide à la décision clinique pour le traitement de patients qui incorpore des données sur un patient pour afficher une information dans des icônes facilement identifiables pour des organes vitaux et des systèmes médicaux, et dans un mode utilisable, en temps réel et actualisé, qui extrait des données de l'histoire médicale, de la prise en charge médicale actuelle, des moniteurs physiologiques actuels et des systèmes médicaux associés pour produire des avertissements et des alertes afin de permettre aux soignants d'être avertis des systèmes physiologiques présentant un risque. Ces données sont non seulement présentées, mais elles utilisent également des requêtes et des calculs en temps réel pour permettre aux soignants de disposer des types de données qui les aident habituellement dans le soin des patients mais qui sont seulement disponibles par l'étude de la littérature médicale et/ou en effectuant des calculs individuels rétrospectifs pendant que le soin est administré au patient.
PCT/US2014/036934 2013-05-06 2014-05-06 Système d'aide à la décision clinique en temps réel ayant des systèmes médicaux comme éléments d'affichage WO2014182677A1 (fr)

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