EP3899971A1 - Verfahren und vorrichtung zur erstellung eines kontinuierlichen verlaufs und zur vorhersage der fluidbilanz eines patienten - Google Patents
Verfahren und vorrichtung zur erstellung eines kontinuierlichen verlaufs und zur vorhersage der fluidbilanz eines patientenInfo
- Publication number
- EP3899971A1 EP3899971A1 EP19832639.9A EP19832639A EP3899971A1 EP 3899971 A1 EP3899971 A1 EP 3899971A1 EP 19832639 A EP19832639 A EP 19832639A EP 3899971 A1 EP3899971 A1 EP 3899971A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- patient
- cumulative fluid
- cumulative
- cfb
- fluid balance
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- 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
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
-
- 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
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
-
- 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
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
-
- 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
- G16H40/63—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 local operation
Definitions
- the present invention relates to a method and an apparatus for
- a balance In order to stabilize the patient hemodynamically in the long term, a balance must be found between the total amount of liquids supplied to the patient and the total amount of liquids lost by the patient. This is usually achieved in the context of a fluid balance of the patient by subtracting the total amount of liquids lost by the patient from the total amount of liquids supplied to the patient at a certain point in time to determine a fluid balance of the patient at this point in time and to adapt the liquid supply accordingly. In clinical practice, such a fluid balance is usually collected every 24 hours during the patient's stay in the intensive care unit.
- the treating doctor is therefore only able to use discrete values or individual data points for the fluid balance, on the basis of which the further one is available
- Course of treatment e.g. drug administration, fluid administration etc.
- the attending doctor usually only receives a relative fluid balance, which reflects the change in the fluid balance of the patient since the last fluid balance assessment (i.e. e.g. 24 hours beforehand).
- the present invention is based on the object, a method and a
- the above object is achieved by a method according to claim 1, an apparatus according to claim 8 and a program product according to claim 11.
- the program product can be used to retrofit existing devices, such as blood treatment or fluid balancing systems, in the sense of the invention.
- a transfer function also referred to as a transfer function, system function or controlled system
- a transfer function is created for a patient by means of the a (measured or calculated from measured values) preferably continuous course of the fluid balance of the patient can be simulated for the past (afterwards) and a predicted preferably continuous course of the fluid balance (or a predicted one)
- a transfer function used in the context of the invention can be, for example, a discrete-time transfer function P [z] with the general formula shown below:
- Y [z] and U [z] are the Z transforms of output and
- Input variables bo to b m and ao to a n are the coefficients of the transfer function.
- n denotes the degree of the transfer function.
- CFI cumulative fluid supply
- CFB cumulative fluid balance
- the course of the CFI for the past is preferably only determined using the approximation method.
- the course of the CFB for the past is determined by using the CFI, which is preferably approximated by means of an approximation method, as the input for the transfer function.
- the output sequence then contains the approximated CFB.
- the CFI is predicted by extrapolating the CFI, which is preferably approximated with the aid of the approximation method, or the prediction of a target CFI can also be carried out by integrating the transfer function into a control loop and setting a target CFB.
- the CFB is predicted by using the CFI, which is preferably approximated and extrapolated via the approximation method, as the input for the transfer function.
- the output sequence then contains the approximated, predicted CFB. , or the CFB can also be predicted by integrating the transfer function into a control loop and defining a target CFB.
- the control loop then contains the actually expected target CFB, which, if the control loop manages to find a suitable target CFI curve, corresponds to the target CFB.
- the transfer function is used in combination with the
- Approximation method as a mathematical model, by means of the data acquired, for example with regard to the fluid supply to the patient and that of the patient
- Fluid supply to the patient can be predicted for the future.
- a cumulative fluid balance is preferably represented by means of the transfer function, which, in contrast to the relative fluid balance known from the prior art, which only shows the difference to the last data point of the fluid balance, shows the overall course of the fluid balance for the patient since the start of the recording (e.g. since the patient was admitted to the intensive care unit).
- the preferably cumulative fluid balance is determined by subtracting the
- Fluid delivery to the patient is calculated.
- the total amount of liquids lost by the patient is preferably subtracted from the total amount of fluid / liquid supply to the patient.
- Liquids are all liquids lost by the patient, e.g. the amount of urine excreted by the patient, insensitive losses, but also the
- an approximation method can also be used to map a cumulative fluid supply which reproduces the overall course of the fluid supply to the patient since the start of the recording (for example since the patient was admitted to the intensive care unit).
- a method according to the invention comprises the steps:
- CFI cumulative fluid delivery
- CFB patient's cumulative fluid balance
- Approximation method of a predicted continuous course or trend of the cumulative fluid supply and / or the cumulative fluid balance of the patient for the future is a predicted continuous course or trend of the cumulative fluid supply and / or the cumulative fluid balance of the patient for the future.
- Fluid delivery to a patient is to be mapped using an approximation method, the method comprising the following steps:
- Approximation method from the recorded data relating to the cumulative fluid supply, the cumulative fluid supply of the patient can be determined
- the method can include the following steps:
- Transfer function in combination with an approximation method of the course of the cumulative fluid balance can be determined.
- the method according to the invention comprises the steps:
- the determined continuous courses of the cumulative fluid supply and / or the cumulative fluid balance for each patient for the past and future can be displayed together or separately on a display device.
- the continuous courses of the cumulative fluid supply and / or the cumulative fluid balance for each patient for the past and future displayed in this way can thus be made available to a treating doctor when deciding on the further course of treatment.
- the patient therefore not only receives individual data points, but also a continuous course of the cumulative fluid supply and / or the cumulative fluid balance for each patient during their entire stay in the intensive care unit, as well as a prediction of the further development of the course of the cumulative fluid supply and / or the cumulative fluid balance for this patient. This improves the
- a method according to the invention further comprises the steps:
- the patient is then informed on the basis of the calculated course of the cumulative fluid supply to the patient, by means of which the actual value or actual course of the cumulative fluid balance for the patient is adjusted to the setpoint value or setpoint.
- the course of the cumulative fluid balance can be brought, supplied with fluid until the actual value or actual course of the cumulative fluid balance for the patient corresponds to the set value or target course of the cumulative fluid balance.
- the setpoint value or setpoint curve can correspond to a desired positive or negative gradient of the curve in a specific time interval.
- the cumulative fluid supply to the patient can also be regulated using the transfer function for this patient.
- the procedure includes the steps:
- the patient is then brought on the basis of the calculated course of the cumulative fluid supply to the patient, by means of which the actual value or actual course of the cumulative fluid supply for the patient is brought to the set value or set course of the cumulative fluid supply can, fluid supplied until the actual value or actual course of the cumulative fluid supply for the patient corresponds to the set value or set course of the cumulative fluid supply.
- the target value or The desired course can correspond to a desired (positive) gradient of the course in a specific time interval.
- an invention comprises
- the turning point can be determined either from the raw data for CFI or CFB for the past (this is done here for the CFI to get the CFI approximation) or from the predicted data for the CFI (data are generated either by approximation and extrapolation or when setting of a target CFB course in the control loop) or the predicted data for the CFB (data are generated either by using the transfer function on the CFI smoothed and extrapolated using the approximation method or via the control loop output).
- the inflection point indicates the point in the course of the cumulative fluid balance and / or the cumulative fluid supply at which the patient is off the ebb phase
- a method according to the invention can include a step of
- a method according to the invention can include a step of determining an inflection point in the course of the cumulative fluid balance on the basis of the course of the cumulative fluid balance or on the basis of the continuous course of the cumulative fluid balance for the past and the one calculated using the transfer function in combination with the approximation method predicted continuous progression of the cumulative fluid balance for the future.
- the turning point of the cumulative fluid balance and / or the cumulative fluid supply can be determined by means of an approximation method, in which a number of potential turning points in the course of the cumulative fluid balance and / or the cumulative fluid supply of the patient corresponds to the actual one
- Inflection point closest potential inflection point is selected.
- each point in time can be examined as a potential turning point.
- the determined values can also be examined as potential turning points at defined subordinate time intervals. For example, an hour may occur during the patient's stay in the intensive care unit
- Time interval for example from tO to t1, becomes the potential turning point
- Time t1 determined in the second section of the time interval from tO to t1.
- the two straight lines intersect at the potential turning point, which in the first section and in the second section of the time interval from tO to t1 reflect the course of the cumulative fluid balance and / or the cumulative fluid supply.
- any other function e.g. a non-linear function, can be used for interpolation or regression.
- the approximate determination of the turning point can be carried out for any number of passes or with any number of iterations.
- the statistical deviation between the course approximated by means of preferably linear regression through the two straight lines and the actual course is determined.
- the root mean squared error (RSME) is preferably used for this.
- the calculated RSME is compared to the lowest RSME of another
- the currently calculated RSME value is lower, i.e. if the currently examined potential inflection point is closer to the actual inflection point, the currently investigated potential inflection point is currently the best (i.e. the
- the next turning point determined can also be displayed to a treating doctor, for example by means of a display device, as to what the
- the slope of the straight line through the potential inflection point which simulates the course of the cumulative fluid supply to the patient in the second section of the time interval from tO to t1, is used, for example, in a linear extrapolation for the prediction of the cumulative fluid supply to the patient in a second Time interval from t1 to t2 (prediction interval) used.
- the course of the cumulative fluid balance for the patient in the second time interval from t1 to t2 can be predicted.
- the transfer function for the patient is performed periodically at predetermined time intervals, for example every hour
- the preferably cumulative fluid balance and fluid supply updated or adjusted.
- the adjustment can be made, for example, during the patient's entire stay in the intensive care unit. This can ensure that the transfer function reflects the cumulative fluid balance of the patient or the cumulative fluid supply to the patient as precisely as possible for the duration of the patient's total stay in the intensive care unit.
- Transfer function for the patient based on patient cohort specific information in which a particular patient cohort is linked to a specific transfer function to be used for this patient cohort.
- the patient cohort-specific information is preferably generated by common features of the transfer functions created in the past for a specific patient cohort, such as e.g. Poles, zeros, stability, impulse response, step response etc., especially by means of statistical
- Patients belonging to the patient cohort are used as a basis.
- a certain patient cohort refers to a group of patients who share certain characteristics. These features can be, for example, age, gender, treatment or surgery to be carried out, any previous illnesses, length of stay in the intensive care unit, laboratory parameters, etc. Patient cohorts can be formed based on any common characteristics.
- Empirical values can be used.
- a transfer function for the patient on the basis of patient cohort-specific information can also serve to check the plausibility of an individually created transfer function for this patient by comparing the individually created transfer function with one based on
- Patient cohort-specific information created transfer function is compared. Such a comparison increases the accuracy of the transfer function and thus further increases patient safety.
- a method according to the invention can be used for only a single patient, but it can also be used for a plurality of patients. If the method is used for a plurality of patients, a transfer function can be created individually for each of the patients in the plurality of patients. Alternatively or additionally, patient cohorts can also be formed from the plurality of patients and on the basis of
- the data streams of the data collected for the patients of the plurality of patients can thus be for everyone
- Patients are processed separately or can also be merged so that data pools are formed.
- Another aspect of the invention relates to a device which is designed to carry out a method according to the invention in accordance with one of the above aspects.
- the device is preferably a device for extracorporeal blood treatment, a drug administration system
- Fluid management system or an infusion pump or another device which is directly or indirectly related to the fluid balance or the fluid balance and thus the fluid balance of the patient.
- a device preferably has an element or means for collecting the data relating to the preferably cumulative fluid supply to the patient and / or to the preferably cumulative fluid balance of the patient.
- such a device preferably has one
- Display device for example a monitor / display, by means of which the information ascertained (courses, prediction values, turning points) is transmitted to one
- treating doctor can be made available.
- Another aspect of the invention relates to a program product which causes an apparatus to carry out a method according to the invention in accordance with one of the above aspects.
- Drug delivery system a fluid management system, a
- Infusion pump or another device which is directly or indirectly related to the fluid balance or the fluid balance and thus the fluid balance of the patient, to be retrofitted.
- a program product can, for example, be stored on a storage medium.
- the figures 1 a to 1 e show an example of the different steps of a
- Approximation method to determine the trajectory of the cumulative Hydration while determining a turning point in the course of cumulative fluid delivery to a patient.
- the figures 1 a to 1 e show an example of the different steps of a
- the inventive method is applied to a patient.
- the time interval from tO to t1 can be defined as desired and for example a few minutes, 1 hour or even several hours, e.g. 6 hours or 12 hours.
- the time interval can also include the entire duration of the patient's stay in the intensive care unit, for example several days.
- a preferably time-discrete transfer function P [z] is created on the basis of the collected data, which represents a relationship between the data relating to the cumulative fluid supply CFI to the patient and the cumulative fluid balance CFB of the patient.
- the course of the cumulative fluid supply CFI to the patient in this example since
- the transfer function P [z] describes a relation or a
- Fluid supply CFI or the approximate data of the cumulative fluid supply CFI as input sequence and the transfer function P [z] the associated values of the cumulative fluid balance CFB can thus be calculated.
- a prediction for the further course of CFI and CFB in is then based on the course of CFI and CFB determined in the time interval from tO to t1 on the basis of the collected data relating to the patient's CFI and CFB a future time interval from t1 to t2.
- the inflection point in the course of CFI is determined using the approximation method described above (in order to obtain the approximated CFI so far) by examining stepwise points along the course as potential inflection points and the closest one to the actual inflection point
- potential inflection point e.g. the inflection point with the lowest RSME value with respect to the actual inflection point
- a first straight line is drawn through the origin and the potential turning point, which represents the course of CFB or CFI for the section between tO (origin) and the potential turning point.
- a further linear regression is then used to lay a second straight line through the turning point, which represents the course of CFB or CFI for the section between the potential turning point and t1.
- This second straight line in particular the slope of the second straight line, can, as shown in FIG. 1 c, be used for the future course of CFB or CFI for the future, in this example for a course going beyond time t1
- FIG. 1 c The diagrams shown in FIG. 1 c correspond to one example
- treating doctor on a display device displayed data or courses of the cumulative fluid supply or fluid balance of the patient.
- the treating physician can set a target value or a target course of CFI or CFB for the patient.
- a target curve of the cumulative fluid balance CFB was determined for the time interval from t1 to t2.
- a value kMaint is set, which represents a desired gradient in the course of CFB for the time interval from t1 to t2.
- a value of (-A) was set in FIG. 1 d, which represents a desired, in this example negative, slope of the course of CFB for the time interval from t1 to t2.
- a cumulative target fluid balance or a target profile of the cumulative fluid balance cfbgoai is then created on the basis of the target profile of the cumulative fluid balance CFB. According to this target course of
- the proposal for the course of the cumulative fluid supply to the patient cfisugg is adapted by means of a control loop R [z], so that the proposal for the course of the cumulative fluid supply to the patient cfisugg corresponds exactly to the course of the cumulative fluid supply, which according to the transfer function P [ z] leads to the predicted course of the fluid balance cfbpred, which corresponds to the target course of the cumulative fluid balance cfbgoai.
- the trajectory including the turning point can also be determined in the course of the patient's cumulative fluid balance CFB.
- the course of the cumulative fluid supply CFI (B) to a patient is simulated in a time interval from tO (origin) to t1 by means of a linear regression or interpolation (A). Different points along the course are examined as potential turning points (C).
- FIGS. 2a to 2e the potential turning points tp1, tp2, tp3, tp4 and tp (n-m) are shown by way of example, in which the two straight lines of the linear regression / interpolation of the course in the first and second section of the
- the deviation of the approximated cumulative fluid supply from the actual cumulative fluid supply is determined. Specifically, in this embodiment, the deviation is determined by determining a root mean squared error value (RSME), which indicates the deviation of the approximated curve from the actual curve.
- RSME root mean squared error value
- the potential inflection point tp3 shown in FIG. 2c corresponds to the actual inflection point and therefore has the lowest RMSE value (RMSE min).
- the potential turning point with the lowest RSME value is selected step by step.
- the potential turning point tp1 shown in FIG. 2a is first examined. As shown in FIG. 2a, however, tp1 does not come very close to the actual turning point and the associated RMSE value is correspondingly large (RSME TT ).
- the potential inflection point tp1 and the associated RMSE value and the associated straight lines of the linear regression / interpolation are then stored.
- the potential turning point tp2 shown in FIG. 2b is examined. As shown in Fig. 2b, tp2 comes to that actual turning point closer than the potential turning point tp1 and the RMSE value associated with the potential turning point tp2 is correspondingly smaller (RSME ⁇ ) than the RMSE value associated with the potential turning point tp1 (RSME ⁇ ).
- the potential inflection point tp2 and the associated RMSE value and the associated straight lines of the linear regression / interpolation are then stored and the potential inflection point tp1 is rejected.
- the approximate determination of the potential turning point tp3 can alternatively or additionally also be carried out by gradually shifting the potential turning point to be examined in the
- each point in the course is tested as a potential inflection point in a certain interval starting from tO until the end of the course (t1) has been reached. If you find the best turning point somewhere in the middle (which you don't know at the time), the RMSE will get bigger in the next few steps, but you still have to go through the entire time series until the end (t1) to get one Lower RMSE value cannot be overlooked.
- the examination takes place from the first step to the last step, starting from the origin to the right.
- the method could also be started at t1 and ended at tO. Then the method would not change the direction in the middle, but would move along the X axis to the origin in each step.
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- Epidemiology (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract
Description
Claims
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102018009902.5A DE102018009902A1 (de) | 2018-12-20 | 2018-12-20 | Verfahren und Vorrichtung zur Erstellung eines kontinuierlichen Verlaufs und zur Vorhersage der Fluidbilanz eines Patienten |
| PCT/EP2019/085960 WO2020127490A1 (de) | 2018-12-20 | 2019-12-18 | Verfahren und vorrichtung zur erstellung eines kontinuierlichen verlaufs und zur vorhersage der fluidbilanz eines patienten |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP3899971A1 true EP3899971A1 (de) | 2021-10-27 |
Family
ID=69143541
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP19832639.9A Withdrawn EP3899971A1 (de) | 2018-12-20 | 2019-12-18 | Verfahren und vorrichtung zur erstellung eines kontinuierlichen verlaufs und zur vorhersage der fluidbilanz eines patienten |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US20220076833A1 (de) |
| EP (1) | EP3899971A1 (de) |
| CN (1) | CN113383394A (de) |
| DE (1) | DE102018009902A1 (de) |
| WO (1) | WO2020127490A1 (de) |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10011395A1 (de) * | 2000-03-09 | 2001-09-20 | Braun Melsungen Ag | Fluid-Bilanzierungssystem |
| US7818184B2 (en) * | 2002-09-24 | 2010-10-19 | Draeger Medical Systems, Inc. | Patient medical fluid parameter data processing system |
| EP1881786B1 (de) * | 2005-05-13 | 2017-11-15 | Trustees of Boston University | Vollautomatisches kontrollsystem für diabetes typ 1 |
| US7857803B1 (en) * | 2007-03-19 | 2010-12-28 | The United States Of America As Represented By The Secretary Of The Army | Burn patient resuscitation system and method |
| JP5750123B2 (ja) * | 2010-02-11 | 2015-07-15 | ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニア | 生物学的因子又は薬物を被検者に送達するためのシステム、装置及び方法 |
-
2018
- 2018-12-20 DE DE102018009902.5A patent/DE102018009902A1/de not_active Withdrawn
-
2019
- 2019-12-18 EP EP19832639.9A patent/EP3899971A1/de not_active Withdrawn
- 2019-12-18 CN CN201980090614.4A patent/CN113383394A/zh active Pending
- 2019-12-18 WO PCT/EP2019/085960 patent/WO2020127490A1/de not_active Ceased
- 2019-12-18 US US17/415,330 patent/US20220076833A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| DE102018009902A1 (de) | 2020-06-25 |
| WO2020127490A1 (de) | 2020-06-25 |
| US20220076833A1 (en) | 2022-03-10 |
| CN113383394A (zh) | 2021-09-10 |
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