EP3234831A1

EP3234831A1 - Method, data-processing device, computer program product, and data carrier for indexing at least one hemodynamic and/or biochemical parameter of a patient

Info

Publication number: EP3234831A1
Application number: EP15817231.2A
Authority: EP
Inventors: Wolfgang Huber
Original assignee: Technische Universitaet Muenchen
Current assignee: Technische Universitaet Muenchen
Priority date: 2014-12-19
Filing date: 2015-12-17
Publication date: 2017-10-25
Also published as: WO2016097177A1; DE102014226674A1

Abstract

The invention relates to a method for indexing at least one hemodynamic and/or biochemical parameter of a patient, comprising the steps of sensing the at least one hemodynamic and/or biochemical parameter and calculating at least one indexed hemodynamic and/or biochemical parameter on the basis of the sensed hemodynamic and/or biochemical parameter, at least one biometric parameter, and/or at least one correction parameter. The invention further relates to a data-processing device, comprising means for performing the method according to the invention. A further aspect of the invention relates to a computer program product, comprising program parts that are designed to perform a method according to the invention when loaded in a computer, and to a data carrier that comprises the computer program product according to the invention.

Description

Method, data processing device,

Computer program product and data carrier for indexing at least one hemodynamic and / or biochemical parameter of a patient

description

The invention relates to a method for indexing at least one hemodynamic and / or biochemical parameter of a patient, and to a data processing device having means for carrying out such a method. Furthermore, the present invention relates to a computer program product with program parts which, when loaded in a computer, are designed to carry out such a method. Another aspect of the present invention relates to a data carrier comprising such a computer program product.

For example, hemodynamic parameters are characteristic volumes, such as cardiac output (CO), global end-diastolic volume (GEDV), and extravascular lung water volume (EVLW). Biochemical parameters include, for example, blood gas levels, leukocyte count, hematocrit and serum creatinine concentration.

Such hemodynamic and / or biochemical parameters, which quantitatively represent the blood flow in the blood vessels as a function of the responsible forces and their biochemistry, are used in particular in the monitoring of patients in the intensive care unit. From these parameters or from their change, changes in the state of health of the patients can be directly derived. Thereafter, appropriate countermeasures such as e.g. the administration of liquid or cardiovascular drugs.

Most of the parameters used to monitor patients are initially measured as absolute values. Same absolute values can at However, different individuals have significantly different causes and effects. Therefore, these absolute values must be related to the individual, ie indexed.

Currently, when indexing hemodynamic parameters, it is primarily simple, nonspecific biometric parameters, e.g. Body measurements (height, body weight, body surface) are used, sometimes in simple combinations such. body mass index (BMI) and body surface area (BSA). In addition, many hemodynamic parameters, e.g. central venous pressure (ZVD), pulmonary artery wedge pressure (PAWP) and stroke volume variation (SW) are not indicated. Conversely, these parameters would have to be applicable to all patients in all situations with the same standard values.

The previous indexing are easy to calculate, but involve a variety of disadvantages. The present method of indexing hemodynamic parameters unsatisfactorily indicates haemodynamic parameters. This significantly reduces their information value. In particular, the current indexing leads to a non-specific and poorly differentiated indexing.

Furthermore, the current indexing of hemodynamic parameters is partly manufacturer dependent. That is, individual hemodynamic parameters are indexed by different monitor manufacturers using different parameters. For example, one manufacturer also uses the predicted bodyweight to calculate the body surface area for indexing the global end-diastolic volume (GEDV), whereas another manufacturer uses the actual body weight to calculate the body surface area.

Furthermore, the indexing of haemodynamic parameters and the resulting normal ranges have been evaluated and validated primarily in healthy volunteers. However, due to the invasiveness of the measurement technique used, many of the haemodynamic parameters are predominantly used in the seriously ill, in which the measured absolute values need not only be related to biometric parameters, but also in the context of the particular disease and therapeutic measures must be seen. For example, in patients with atrial fibrillation, a significantly higher indexed global end-diastolic volume (GEDVI) can be expected than in normal heart rhythm patients, whereas lowering the indexed global end-diastolic volume (GEDVI) in patients could be fatal in the normal range validated in healthy volunteers.

It is therefore an object of the present invention to propose a method for the indexing of hemodynamic and / or biochemical parameters, which allows an accurate and meaningful indexing of the hemodynamic and / or biochemical parameters.

According to the invention, this object is achieved by a method for indexing at least one hemodynamic and / or biochemical parameter of a patient, comprising the steps:

Detecting at least one hemodynamic and / or biochemical parameter, and

Calculating at least one indexed hemodynamic and / or biochemical parameter based on the detected hemodynamic and / or biochemical parameter, at least one biometric parameter and / or at least one correction parameter.

By this method results in a variety of advantages. In particular, by the use of one or more correction parameters, an adequate, specific indexing of the hemodynamic and / or biochemical parameter can be made possible. The indexing method not only takes biometric parameters (such as body size, age, body surface area, body weight) into account, but also other influencing factors, thereby avoiding potential mistakes. Thus, the significance of the indexed hemodynamic and / or biochemical parameter can be significantly increased. This, in turn, can lead to better and more appropriate treatments, which can also help to avoid false, life-threatening decisions. The term "indexing" means that a recorded value (raw value) is related to the individual.The patient is understood as meaning both a healthy and a diseased creature, in particular a healthy person as well as a sick person.The proposed method for indexing at least one Hemodynamic and / or biochemical parameters are most preferably used in the seriously ill.

In particular, the correction parameter may not be biometric or biometric. Biometric parameters or parameters of a biometric nature are the parameters that relate to personal characteristics or physical / physical measurements of a patient. These include estimated parameters that do not describe an actual biometric characteristic of the patient, but rather indicate an estimated value for the corresponding biometric characteristic, such as the predicted bodyweight. Among other things, the size, weight, body surface of a patient are biometric parameters. Biometric parameters also include age and gender.

Furthermore, the method according to the invention offers the advantage of an objective indexing. Thus, the inventive method can find use in monitoring devices from different manufacturers, whereby the problem of manufacturer-dependent indexing can be eliminated. Thus, e.g. the hemodynamic parameters of a patient detected by a manufacturer's monitor are directly and reliably compared with the hemodynamic parameters of another patient detected by a third-party monitor. Also, the hemodynamic parameters of the same patient can be compared with each other, e.g. the patient is transported from one intensive care unit to another using another monitor.

The object is further achieved by a data processing device comprising means for carrying out the method according to the invention, and a computer program product comprising program parts which, when loaded in a computer, are designed to carry out the method according to the invention.

Furthermore, the present invention relates to a data carrier which comprises the computer program product according to the invention.

The dependent claims contain advantageous developments and refinements of the invention. The correction parameter may preferably include at least one data acquisition parameter that describes the boundary conditions of the data acquisition. Thus, information regarding the conditions under which data collection, that is, detection of the hemodynamic and / or biochemical parameter, may be taken into account in the calculation of the indicated hemodynamic and / or biochemical parameter. This has the consequence that the dependency of the parameter to be indexed from the data acquisition into the indexing flows, whereby a more accurate indexing is possible.

More preferably, the data acquisition parameter can be derived from the type of a measurement technique used and / or an individual pathology of the patient and / or an applied therapeutic measure.

As a type of measurement technique used, for example, a situation in which a catheter is inserted into the patient to understand. For example, the indicator dilution method for measuring cardiac output and other volumetric parameters is based on injection of the indicator via a central venous catheter catheter tip catheter at the entrance to the right atrium (in the jugular vein or subclavian vein). However, in clinical practice and especially in intensive care units, about 1/3 of the central venous catheters in the femoral vein with the catheter tip are located clearly proximal to the right atrium. This significantly increases the volume of distribution of the indicator. This measures the indicated global end-diastolic volume (GEDVI) by an average of approximately 100 to 250 ml / m ² higher than the standard catheter position in the jugular vein. For a standard range of 680-800 ml / m ² , the adulteration is therefore greater than the difference between the upper and lower normal values (800 ml / m ² -680 ml / m ² = 120 ml / m ² ). Without appropriate correction, not only useless, but dangerously wrong values are created.

Furthermore, the length of the catheter can be taken into account. So z. B. caused by the femoral catheter layer adulteration in very long catheters and / or small people significantly lower.

Many parameters are measured by injecting eg 15ml of ice-cold saline solution. The use of saline at room temperature instead of ice-cold solution (temperature of 4 ° C) leads to slightly different results, which can also be corrected. Accordingly belongs also to the type of used the temperature of the saline used for the measurement. Furthermore, the type and size of the catheter used can have an influence, since in the case of large-lumen catheters (eg dialysis catheters) with a self-volume of up to 2 ml, a relevant part of the indicator "sticks" at least during the first measurement in the catheter, resulting in a reduced indicator volume thus leading to an overestimation of volumetric quantities.

The individual pathology of the patient takes into account the influence of the pathology on the hemodynamic and / or biochemical parameters. For example, it is considered whether a patient has a normal heart rhythm or an arrhythmia, or whether his intra-abdominal pressure is increased. Thus, the detected absolute value of the hemodynamic and / or biochemical parameter may be considered in the context of the particular disease, e.g. other values are to be expected in sick patients with different pathologies. Thus, for example, by considering individual pathology in patients with atrial fibrillation, a significantly higher indexed global end-diastolic volume (GEDVI) is calculated than in healthy normal heart rhythm patients, with a decrease in the indicated global end-diastolic volume (GEDVI) in those in healthy subjects validated standard range could be fatal.

The therapeutic measures concern the measures which have already been taken in a sick patient, e.g. Whether the patient is connected to artificial respiration or dialysis, or whether a parallel applied extracorporeal procedure such. A renal replacement procedure (including, but not limited to, dialysis, CWH (D) F), a liver replacement procedure, extracorporeal lung assist, or a passive leg raising (prone storage).

More preferably, the correction parameter may comprise at least one further hemodynamic and / or biochemical parameter. Thus, the dependencies of the hemodynamic and / or biochemical parameters on other hemodynamic and / or biochemical parameters may be taken into account in the indexing. For example, heart rate and blood pressure can be used as a correction parameter. Preferably, the correction parameter may comprise at least one selection decision parameter via which additional expert knowledge is introduced into the calculation of the indicated hemodynamic and / or biochemical parameter. As additional expert knowledge, the decisions of the doctors or caregivers of the ill patients are to be understood as meaningful correction strategies in the indexing of a hemodynamic and / or biochemical parameter. Namely, the selection decision parameter concerns the evaluation as to whether the indexing of a hemodynamic and / or biochemical parameter needs to be corrected by a certain information. This applies above all to correction parameters which are influenced by the same pathology as the hemodynamic and / or biochemical parameter to be indicated. Thus, the influence of medical sense and practicality on the indexing can be taken into account. For example, stroke volume variation (SW) and heart rate (HR) increase with volume depletion. Due to the derivation of stroke volume variation (SW) ((maximum stroke volume minus minimum stroke volume) / mean stroke volume) over a fixed time interval, more individual stroke volumes are measured in a higher heart rate patient, increasing the chance of extreme values. This can affect the maximum and minimum stroke volume over time. Therefore, at high heart rate (HR), one should not necessarily correct for heart rate (HR), but shorten the interval for determining stroke volume.

Furthermore, the correction parameter may preferably include at least one patient group parameter, via which a patient group is defined. This may increase the quality of the indexing, since the indexing of the same hemodynamic and / or biochemical parameter may differ for individual patient groups. The patient groups can advantageously be defined in part by information from biometric parameters such as gender, from data acquisition parameters such as the ventilation mode, and from selection decision parameters such as the assessment of the heart rhythm. These may preferably be nominal variables, which need not be continuous. For example, atrial fibrillation can become sinus rhythm and vice versa. In addition, ordinal variables can preferably be used as patient groups. The patient group parameter is high. Such patient groups may be, for example, infants, children and adults. Even if a patient changes his or her affiliation with the patient groups, the indexing of the hemodynamic and / or biochemical parameters can be carried out dynamically and adapted to the new patient group. The patient group parameter represents a possible dependency of the indexing of a hemodynamic and / or biochemical parameter on the detectability of the aforementioned correction parameters (data acquisition parameters, selection decision parameters) and / or biometric parameters. In other words, the patient group parameter indicates whether another indexing of the same hemodynamic and / or biochemical parameter should be selected for a particular patient group than that for another patient group or a general indexing not differentiated with respect to a patient group. Thus, there may be patient group indexing in individual cases. Preferably, the patient group parameter does not flow arithmetically into the calculation of an indicated hemodynamic and / or biochemical parameter. That is, the patient group parameter is used to distinguish what is relevant for indexing for a particular group of patients.

For example, in indexing the global end-diastolic volume (GEDV), there may be three groups of patients with respect to cardiac rhythm, namely patients having a sinus rhythm, atrial fibrillation, or a pacemaker rhythm. Three additional groups of patients may be formed with respect to the catheter location when a catheter is inserted into the jugular vein, subclavian vein, or femoral vein. Furthermore, indexing can be different between men and women. Furthermore, a separate indexing for children, which is dependent on their age groups, are made possible.

When indexing the central venous pressure (ZVD), e.g. distinguish between patients with or without increased intra-abdominal pressure. Another possibility is to define patient groups based on the ventilation mode (spontaneous, assisted or controlled) of the patients.

Furthermore, it is advantageous if a plurality of hemodynamic and / or biochemical parameters is indexed and at least one biometric parameter and / or at least one correction parameter for indexing each of the Variety of hemodynamic and / or biometric parameters is chosen such that a mathematical decoupling between the indicated hemodynamic and / or biochemical parameters is achieved. Thus, artificially created correlations between hemodynamic and / or biochemical parameters that might appear when indexing the hemodynamic and / or biochemical parameters with respect to the same biometric parameter and / or the same correction parameter can be reduced. In this case, the at least one biometric parameter and / or the at least one correction parameter for the indexing of a hemodynamic or biochemical parameter are selected or combined with one another, and the at least one biometric parameter and / or the at least one correction parameter for the indexing of a further hemodynamic or biochemical parameter so selected or combined with each other, so that the effects of a mathematical coupling are eliminated or reduced. As a result, the meaningfulness of the indexed parameters can be increased. For example, it is possible to avoid an incorrect correlation between, for example, the global end-diastolic volume (GEDV) and the cardiac output volume (CO).

Particularly preferably, an estimated value can be calculated based on the detected hemodynamic and / or biochemical parameter, at least one biometric parameter and / or at least one correction parameter.

The correction parameter is preferably not biometric or non-biometric.

Advantageously, an indexed hemodynamic and / or biochemical parameter is calculated based on the detected hemodynamic and / or biochemical parameter and the calculated estimate.

When indexing a hemodynamic parameter, the estimated value advantageously corresponds to an expected, estimated value of the hemodynamic and / or biochemical parameter to be indexed taking into account the various influencing factors which are represented by the correction parameters and of which the hemodynamic and / or biochemical parameter is dependent , In particular, the captured hemodynamic and / or biochemical parameters in the context of the particular disease of a patient.

The estimated value reflects a hemodynamic or biochemical target parameter, ie a value of the hemodynamic or biochemical parameter to be expected for a patient, if all relevant contexts, that is, all dependencies of the hemodynamic or biochemical parameter are taken into account , In particular, the estimate takes into account the context of the particular pathology of the patient.

The hemodynamic or biochemical target parameter (estimated value) is of the same nature as the hemodynamic or biochemical parameter to be indicated. Thus, the calculated estimated value for a hemodynamic parameter or biochemical parameter is expressed in the same unit as the detected hemodynamic or biochemical parameter.

The indicated hemodynamic and / or biochemical parameter is preferably calculated by dividing the detected hemodynamic and / or biochemical parameter with the calculated estimate.

For this purpose, the indicated hemodynamic and / or biometric parameter can preferably be normalized to 100% in a simple and accurate manner. This means that the estimated value is calculated in such a way that, for a result of the division of the detected hemodynamic or biochemical parameter with the corresponding calculated estimated value of 100%, the detected hemodynamic or biochemical parameter is equal to the expected value of the hemodynamic or biochemical parameter , Thus, from the result of the above-described division, it can be quickly recognized whether the patient is in a normal (expected) situation taking into account the circumstances / contexts relevant to the patient. By deviating the parameter from 100% in the course of monitoring the patient, it can easily be seen for the hospital staff if and when therapeutic measures are to be taken. These measures can then be suitably selected by the attending physician in a specific case, taking into account the hemodynamic and / or biochemical parameters. For a healthy human, the estimated value of the hemodynamic and / or biochemical parameter is given by the estimated value of a hemodynamic and / or biochemical parameter of the expected value of the conditions relevant to the healthy human. The estimated value of the hemodynamic and / or biochemical parameter in this case is equal to the detected hemodynamic and / or biochemical parameter since the human is healthy.

Accordingly, in the case of a sick person, the estimated value of a hemodynamic and / or biochemical parameter indicates the value of the hemodynamic and / or biochemical parameter to be expected under the circumstances that are relevant for the patient, ie, including his pathology. If the estimated value of the hemodynamic and / or biochemical parameter deviates or a deviation of 100% is found, it can be concluded that measures must be taken.

The calculated estimated value for a hemodynamic and / or biochemical parameter of a healthy human is different from the estimated value for the same hemodynamic and / or biochemical parameter of the diseased human if the other influencing factors are identical.

This means that a percent of 100% in a healthy person and a percent of 100% in a sick person correspond to different estimates.

Particularly preferably, the estimated value can be calculated by a formula, wherein the at least one biometric parameter and / or the at least one correction parameter are weighted. Thus, the importance of the different biometric parameters and / or correction parameters flows into the formula of the estimated value. Further preferred in the formula are the biometric parameters and / or the correction parameters of different types, e.g. linear, quadratic, cubic or exponential.

The estimate may preferably be calculated by a formula of the form _> .K ^a (i) ^* biometric parameter + b (j) ^* correction parameter + constant), where "a (i)" is a weight for the i-biometric parameter, "b (j)" is a weight for the j-correction parameter, "i" is an index for the biometric parameters, "j" is an index for the correction parameters, and "constant" is a constant. The constant can also be zero. For example, an estimated value of a hemodynamic parameter based on two biometric parameters and two correction parameters is given by a formula of the form ,, a (1) ^* 1. biometric parameter + a (2) ^* 2. biometric parameter + b (1) ^* 1st correction parameter + 2nd correction parameter + constant "calculated.

For different patient groups, there may preferably be different formulas for indexing the same hemodynamic and / or biochemical parameters. This can be done particularly preferably by adapting the different weights for the biometric parameters and / or the correction parameters to the respective patient group.

According to a preferred embodiment of the present invention, the hemodynamic parameter to be indexed may be the bounce wave variation (SSV) and the indexed buffing variation on the ventilatory mode and / or the cardiac rhythm, and at least one of the selection of the hemodynamic parameter of the heart rate and the biometric parameters of the heart rate Age and weight of the patient. Thus, an accurate indexing of Schlagvoiumenvariation (SW) is possible, which is not yet indexed.

According to a particularly preferred embodiment of the present invention, the indexed stroke volume variation may be calculated based on the patient's heart rate, cardiac rhythm, age, weight and ventilation mode. Specifically, preferably, the estimated value for calculating the indexed bounce variation (SW) may be calculated by the following formula:

SWcease = -10.192 + 0.133 ^* heart rate + 6.118 ^* heart rhythm + 0.076 ^* age + 0.039 * weight - 2.553 ^* ventilation mode, where

SWcease is the estimate in% and heart rate in rpm, the heart rhythm takes the value 0 when the patient is in sinus rhythm and takes the value 1 when the patient is in atrial fibrillation, age in years, and weight in kg and the ventilation mode takes the value 0 when the patient is breathing without mechanical support and assumes the value 1 when mechanical ventilation is present. The explanatory content of the biometric parameters is low and the estimate increases slightly with age and weight. On the other hand, heart rate, heart rhythm and ventilation mode play an important role in calculating the estimate. Furthermore, the estimated value can be optimized by including the dependence on tidal volumes.

According to a preferred embodiment of the present invention, the hemodynamic parameter to be indexed may be the central venous pressure (ZVD), and the indicated central venous pressure based on the ventilatory mode and / or the cardiac rhythm, and at least one biometric parameter from the selection of the size, the age and the weight of the patient. As a result, the hitherto unindexed parameter of the central venous pressure (ZVD) can be indexed in a precise manner.

In accordance with a particularly preferred embodiment of the present invention, the indicated central venous pressure may be calculated based on the size, age, weight, heart rhythm, and ventilation mode of the patient.

In particular, the estimated value for calculating the indicated central venous pressure (ZVD) may preferably be calculated by the following formula:

ZVDcease = 25,798 - 0,105 * Size - 0.047 ^* Age + 0.058 ^* Weight + 1, 551 ^* Cardiac Rhythm + 2.104 * Ventilation Mode, where

ZVDcease is the estimated value in mmHg, the height in cm, the age in years and the weight in kg, the heart rhythm takes the value 0 when the patient is in sinus rhythm and the value 1 when the patient is in atrial fibrillation , is, and the ventilation mode is 1 for spontaneous breathing, 2 for pressure-assisted ventilation, and 3 for pressure-controlled ventilation.

The influence of the ventilation mode on the estimated value and accordingly the indicated central venous pressure is high. However, the biometric parameters have a low explanatory content. Furthermore, in a group of patients with an increased intra-abdominal pressure, the high influence of the intra-abdominal pressure on the indexing of the central venous pressure can also be taken into account as an optimization possibility. According to a still further preferred embodiment of the present invention, the hemodynamic parameter to be indexed may be the stroke volume (SV) and the indicated heartbeat volume based on the heart rhythm and at least one biometric parameter from the selection of the size, Age and weight of the patient can be calculated. Thus, the previous inaccurate indexing of the stroke volume (SV) based on the body surface can be corrected.

More preferably, the indicated heartbeat volume may be calculated based on the size, age, weight, and heart rhythm of the patient. In particular, the estimated value for calculating the indicated stroke volume (SV) may preferably be calculated by the following formula:

SVcease = -21, 202 + 0.721 ^* Size - 0.639 * Age + 0.464 ^* Weight - 15,389 ^* Heart rhythm, where

SVcease is the estimated value in milliliters, the height in centimeters, the age in years and the weight in kilograms, and the heart rhythm takes the value 0 when the patient is in sinus rhythm and the value 1 when the patient is in atrial fibrillation located.

In this case, the biometric parameters have a high explanatory content, the estimated value increasing with the size and weight of the patient and decreasing with age. Gender does not matter. Furthermore, the estimated value decreases with the heart rhythm.

In yet another preferred embodiment of the present invention, the hemodynamic parameter to be indexed may be the global end-diastolic volume, and the indexed global end-diastolic volume based on the patient's cardiac rhythm and / or catheter location, and at least one size-selected biometric parameter , age, weight and gender. Thus, manufacturer-independent indexing of the global end-diastolic volume (GEDV) can be made possible in comparison to the two previous, manufacturer-dependent indexes based on the predicted body surface area or the actual body surface. More preferably, the indicated global end-diastolic volume (GEDV) may be calculated based on patient size, age, weight, and cardiac rhythm, and catheter location.

In particular, the estimated value for calculating the indexed global end-diastolic volume may preferably be calculated by the following formula:

GEDVcease = -1314,767 + 13,235 * Size + 8,808 * Age + 3,775 ^* Weight - 151, 178 ^* Sex + 70,716 ^* Heart rhythm -134,502 ^* Catheter location, where

GEDVcease the estimated value in ml, the height in cm, the age in years and the weight in kg, the sex assumes the value 1 for men and 2 for women, the heart rhythm takes the value 0, if the patient is in the sinus rhythm, and is 1 when the patient is in atrial fibrillation, and the catheter location is 1 when the catheter is inserted into the femoral vein and becomes 2 when the catheter is inserted into the jugular vein or subclavian vein ,

In this case, the biometric parameters have a high explanatory content, the estimated value increasing with the size, weight and age of the patient. For female gender (patient group: women) the estimated value decreases. Furthermore, the estimate increases with a femoral rather than jugular or subclavicular catheter location. The estimate also increases significantly with atrial fibrillation. Thus it can be avoided that in patients with atrial fibrillation not physiologically low values are sought.

According to another another preferred embodiment of the present invention, the biochemical parameter to be indicated may be the central venous oxygen saturation (S _cv 0 ₂ ) and the indicated central venous oxygen saturation based on catheter location and / or arterial hematocrit and / or arterial oxygen saturation, and Age of the patient can be calculated. Central venous oxygen saturation is used as a surrogate for cardiac output (CO), but it also depends on other parameters.

More preferably, the indicated central venous oxygen saturation may be calculated based on the patient's age, arterial hematocrit, and arterial oxygen saturation, and catheter location. In particular, the estimated value for calculating the indicated central venous oxygen saturation may preferably be calculated by the following formula:

S _cv 0 ₂ cease = -60.85 - 0.151 ^* age- 2.493 ^* catheter location + 0.272 ^* arterial hematocrit + 1.445 ^* S _a 0 _2> where

S _cv 0 ₂ cease is the estimated value in% and the age in years, the catheter position assumes the value 1 when the catheter is inserted into the jugular vein or the subclavian vein, and assumes the value 2 when the catheter enters the femoral vein is used, the arterial hematocrit in% and the arterial oxygen saturation in%.

The object of the present invention is further characterized by a method for indexing at least one hemodynamic and / or a biochemical parameter of a patient, comprising the steps:

Capture at least one hemodynamic and / or biochemical parameter, and

Calculating at least one indexed hemodynamic and / or biochemical parameter based on the detected hemodynamic and / or biochemical parameter, and at least the age and the size of the patient.

Thus, a more accurate indexing of the indicated hemodynamic and / or biochemical parameter is achieved.

Particularly preferably, an estimated value can be calculated based on the detected hemodynamic and / or biochemical parameter, and at least the age and the size of the patient.

When indexing a hemodynamic or biochemical parameter, the estimated value advantageously corresponds to an estimated value of the hemodynamic or biochemical parameter to be indexed, taking into account the dependencies of the hemodynamic or biochemical parameter. biochemical parameter at least to the age and size of the patient,

In this case, the estimated value corresponds to a hemodynamic or biochemical target parameter which is to be expected in a patient if all relevant contexts, that is, all dependencies of the hemodynamic or biochemical parameter, are also taken into account. The hemodynamic or biochemical target parameter is of the same nature as the hemodynamic or biochemical parameter to be indicated. Thus, the calculated estimated value for a hemodynamic parameter or biochemical parameter is expressed in the same unit as the detected hemodynamic or biochemical parameter.

For this purpose, the indicated hemodynamic and / or biometric parameter can preferably be normalized to 100% in a simple and accurate manner.

The estimate may preferably be calculated by a formula of the form "c * age + d * magnitude + constant", where "c" is a weight for the parameter of age, "d" is a weight for the parameter of magnitude, and "constant" is one Constant are. The constant can also be zero.

According to a preferred embodiment of the invention, the hemodynamic parameter to be indexed may be the cardiac output volume (CO) and the indicated cardiac output volume further calculated based on the weight. Thus, the previous indexing based on the body surface can be corrected. The estimated value is additionally calculated based on the weight of the patient. Specifically, the estimate is calculated by a formula of the form "c * age + d ^* magnitude + e ^* weight + constant", where "e" is a weight for the parameter of weight (body weight).

In particular, the estimated value for calculating the indicated cardiac output volume may preferably be calculated by the following formula:

HZVcease = 0.899 + 0.052 ^* size - 0.085 ^* age + 0.033 ^* weight, where HZVcease is the estimated value in L / min, the size in cm, the age in years and the weight in kg.

In this case, the biometric parameters have a high explanatory content, whereby the estimated value increases with the size and the weight, and decreases with age. The gender (patient group) has no influence on the indexing. Furthermore, the estimated value decreases with the heart rhythm. However, the cardiac output volume is a marker of global perfusion, in which the heart rhythm has an explanatory content, but should not affect the target value. In case of doubt, the clinician will first evaluate the indicated cardiac output and, in the case of pathological values, use the indicated stroke volume, which is also corrected based on the heart rhythm, as a decision-making aid.

According to another preferred embodiment of the present invention, the hemodynamic parameter to be indexed may be the extravascular lung water (EVLW), and the estimated value for calculating the indicated extravascular lung water may be calculated by the following formula:

EVLWcease = -649,361 + 7,217 * size + 1, 635 ^* age, where

EVLWcease is the estimate in ml, which is in cm and the age in years.

Thus, the extravascular lung water previously indicated based on the actual or predetermined body weight, which is a marker with a very high signal-to-noise ratio, can be corrected. Thereby, e.g. It should be avoided that in obese patients to false low levels of the indicated extravascular lung water result. The size is the only biometric parameter with independent association. Furthermore, there is a borderline association with age, with no independent association with weight and gender.

Further preferably, the at least one detected hemodynamic parameter and / or biochemical parameters and / or the at least one biometric parameter and / or the at least one correction parameter and / or the at least one indicated hemodynamic and / or biochemical parameter can be stored in a database. Thus, the detected and indexed parameters of monitors of Different manufacturers with little effort and elimination of operating errors and transmission errors for a comprehensive evaluation are available.

Particularly preferably, the at least one hemodynamic parameter and / or biochemical parameter can be indexed dynamically. Thereby, the indexing to changes e.g. the disease state of the patient, the therapeutic measures, etc. are adjusted. The indexing of each individual parameter can be changed within a very short time "context-related. For example, the indexing of a hemodynamic parameter can be adjusted when the heart rhythm changes. Preferably, furthermore, the database may be optimized by any new hemodynamic parameter and / or biochemical parameter detected, as well as the new correction parameters, e.g. the formulas for calculating the respective estimates are adjusted accordingly. In particular, the weights and constants in the formulas of the estimates can be dynamically adjusted.

The above-described correction parameters can preferably be detected, at least partially, automatically. Alternatively, the correction parameters or the values of the correction parameters can be entered manually.

To facilitate its applicability, as much of the data as possible should be collected automatically. Therefore, in addition to the manual input possibility of each relevant context via a keyboard, the invention additionally offers the possibility of an automated context capture (eg rhythm analysis, catheter recognition, correction for the injectate temperature) as well as the ability to detect data detected by compatible measuring devices "(eg ventilation parameters via interfaces of ventilators, information from the PDMS).

The indexed parameters are represented numerically and graphically on a screen in the invention. Corresponding data can be passed on via an interface to the hemodynamic monitors.

Further details, features and advantages of the invention will become apparent from the following description of embodiments of the present invention. In a first embodiment, the method is performed for indexing a plurality of hemodynamic parameters of a patient via means of a data processing device. In particular, stroke volume variation (SW), central venous pressure (ZVD), stroke volume (SV) and global end-diastolic volume of a patient are indicated.

First, the hemodynamic parameters are detected by means of a detection device. For each hemodynamic parameter, an estimate is calculated by a specific formula.

Specifically, in this embodiment, the estimate for stroke volume variation (SW) is calculated by the formula: SWcease = -10.192 + 0.133 ^* heart rate + 6.118 * heart rhythm + 0.076 ^* age + 0.039 ^* weight - 2.553 ^* ventilation mode.

For Central Venous Pressure (CVD), the corresponding estimate is calculated by the formula ZVDcease = 25,798 - 0,105 ^* Size - 0,047 * Age + 0.058 ^* Weight + 1, 551 ^* Heart Rhythm + 2.104 ^* Ventilation Mode.

For the stroke volume (SV), the corresponding estimate is calculated by the formula SVcease = -21, 202 + 0.721 ^* size - 0.639 ^* age + 0.464 ^* weight - 15.389 * heart rhythm.

For global end-diastolic volume (GEDV), the corresponding estimate is calculated by the formula GEDVcease = -1314.767 + 13.235 ^* size + 8.808 ^* age + 3.775 ^* weight - 151, 178 ^* sex + 70.716 ^* heart rhythm - 134.502 ^* catheter location.

The values for the size, age, weight and gender of the patient for calculating the estimated value can be entered into the data processing device by a user interface or already stored in a database. Also conceivable is an automatic detection of the size and weight of the patient.

The values for the heart rhythm and the ventilation mode, which serve as correction parameters, can be detected automatically. In this case, the same detection device for detecting the hemodynamic parameters or another detection device can be used. Once the corresponding estimate has been calculated for each hemodynamic parameter, the indexing of hemodynamic parameters can be performed. This is achieved by dividing the respective detected hemodynamic parameter by the corresponding calculated estimated value.

The results from the division correspond to the indicated hemodynamic parameters SWcesar, ZVDcesar, SVcesar and GEDVcesar, which can be used to monitor the patient's circulation. Furthermore, the indicated hemodynamic parameters may preferably be normalized to 100% so that a deviation of their values of 100% is an indication that treatment measures must be taken.

In order to promote the understanding of the embodiment according to the invention, an arithmetic example will be described below. The global end-diastolic volume is measured in a human and is 2,000 ml. The expected estimate is calculated by the above formula taking into account the relevant correction parameters, resulting in a global end-diastolic volume of 1,600 ml. The reading is then divided by the estimate and then multiplied by 100%. This results in an indexed parameter GEDVcesar of 125%. This means that therapeutic measures must be taken. The greater the deviation of the indexed parameter of 100%, the more important and faster measures must be taken. In other words, an indexed parameter is 100% when a human has no pathology that is not explained by the detected context.

By means of the method according to the invention, a reliable, accurate, parameter-specific and meaningful indexing of hemodynamic and / or biochemical parameters is possible, the indicated hemodynamic and / or biochemical parameters being corrected for specific information.

Advantage of the indexing according to the invention is the emergence of a dimensionless size CESAR, which is ideally 1 or 100%. Mean normal value of all CESAR indexed parameters is 100%. This simplifies the handling considerably and is an aid for therapy control by algorithms. The "context-specific indexing according to the invention can also provide uniform norm values for all individuals having a different biometry and provide different non-biometric contexts. In other words, "context" -sensitive indexing simplifies the application of multiple hemodynamic and / or biochemical parameters through a single normative system.

In a second embodiment, in addition to the hemodynamic parameters of the first embodiment, a biochemical parameter is additionally indicated. In particular, in this embodiment, the estimate for central venous oxygen saturation is calculated by the formula S _cv 0 ₂ cease = -60.85 - 0.151 ^* age - 2.493 ^* catheter location + 0.272 ^* arterial hematocrit + 1.445 ^* S _a 0 ₂ .

It should be noted that the foregoing embodiments are for illustrative purposes only and not for the purpose of limiting the invention. Various changes and modifications are possible within the scope of the invention without departing from the scope of the invention and its equivalents.

Thus, for example, the method according to the invention for indexing further hemodynamic and / or biochemical parameters than those mentioned above can be used. Hemodynamic parameters include Cardiac Function Index (CFI), Cardiac Power Index (CPI), Pulmonary Vascular Resistance Index (PVR (I)), Left Ventricular Stroke Work (Index) (LVSW (I)), Right Ventricular Stroke Work (Index) (RVSW (I)), Coronary Artery Perfusion Pressure (CPP), Oxygen Delivery (Index) (D0 ₂ (l)), Oxygen Consumption (Index) (V0 ₂ (l)), Oxygen Extraction Ratio ( 0 ₂ ER), Oxygen Extraction Index (0 ₂ EI), Pulmonary Arterial Wedge Pressure (PAWP), Right Ventricular End-Diastolic Volume (Index) (Right Ventricular End-Diastolic Volume (index), RVEDV (Right Ventricular End-systolic Volume (index), RVESV (I)), Right Ventricular Ejection Fraction (RVEF), Arterial Oxygen Content (Right Ventricular End-systolic Volume (index), RVESV (I)), Right Ventricular End-systolic Volume (index) Arterial Oxygen Content, (Ca0 ₂ )) and Venous Oxygen Content (Cv02). Further biochemical parameters that can be indexed by the method according to the invention are the following: leukocytes, hemoglobin, hematocrit, creatinine, creatinine, urea nitrogen in serum (Blood Urea Nitrogen, BUN), creatinine kinase (CK), albumin, lactate dehydrogenase (LDH ), Potassium, calcium, phosphate, cholesterol, triglycerides and alkaline phosphatase. Furthermore, in the aforementioned For example, the following groups of patients should be considered in biochemical parameters: infants, infants, children, adults (older than 80 years old), pregnancy, trimesters, women, men.

Further aspects of the present invention are as follows:

A method is proposed for calculating an estimated value for at least one hemodynamic and / or biochemical parameter of a patient, which can be used in particular for indexing the hemodynamic and / or biochemical parameter, wherein the estimated value is based on at least one biometric parameter and / or or at least one correction parameter is calculated, wherein the estimated value indicates a value for the hemodynamic and / or biochemical parameter to be expected by the patient under given contexts.

According to a preferred embodiment, the correction parameter is not biometric or biometric. Biometric parameters or parameters of a biometric nature are the parameters that relate to personal characteristics or physical / physical measurements of a patient. It also includes estimated parameters, such as the predicted bodyweight, which do not describe an actual characteristic of the patient but indicate an estimated value for that characteristic. Among other things, the size, the weight, the body surface are biometric parameters. Biometric parameters can also be understood as age and sex.

The correction parameter preferably comprises at least one data acquisition parameter which describes the boundary conditions of the data acquisition, in particular the data acquisition parameter results from the type of a used measurement technique and / or an individual pathology of the patient and / or an applied therapeutic measure.

The correction parameter preferably comprises at least one further hemodynamic and / or biochemical parameter. The correction parameter preferably comprises at least one selection decision parameter via which additional expert knowledge is introduced into the calculation of the indicated hemodynamic and / or biochemical parameter.

The correction parameter comprises at least one patient group parameter via which a patient group is defined.

Preferably, the estimated value for the stroke volume variation (SSV) hemodynamic parameter may be calculated, wherein the estimated value is the ventilatory mode and / or the heart rhythm, and at least one of the selection of the hemodynamic parameter of the heart rate and the biometric parameters of age and weight of the patient is calculated.

More preferably, the estimate of stroke volume variation may be calculated based on the patient's heart rate, heart rhythm, age, weight, and ventilation mode. In particular, the estimate of the stroke volume variation may preferably be calculated by the following formula:

SWcease is the estimate in% and heart rate in rpm, the heart rhythm takes the value 0 when the patient is in sinus rhythm and takes the value 1 when the patient is in atrial fibrillation, age in years, and weight in kg and the ventilation mode takes the value 0 when the patient is breathing without mechanical support and assumes the value 1 when mechanical ventilation is present.

Preferably, the central venous pressure (CVED) hemodynamic parameter estimate may be calculated, wherein the estimated value is calculated based on the ventilatory mode and / or heart rhythm, and at least one biometric parameter from the selection of the size, age, and weight of the patient becomes.

Most preferably, the estimate for central venous pressure may be based on size, age, weight, heart rhythm, and heart rate Ventilation mode of the patient can be calculated. In particular, the estimate for central venous pressure may preferably be calculated by the following formula:

ZVDcease = 25,798 - 0,105 ^* Size - 0.047 ^* Age + 0.058 ^* Weight + 1, 551 ^* Cardiac Rhythm + 2.104 ^* Ventilation Mode, where

Preferably, the estimate of the hemodynamic parameter of the stroke volume (SV) may be calculated, wherein the estimate is calculated based on the heart rhythm and at least one biometric parameter from the selection of the size, age, and weight of the patient.

More preferably, the estimated heartbeat volume is calculated based on the size, age, weight, and heart rhythm of the patient. In particular, the estimated heartbeat volume estimate may be calculated by the following formula:

SVcease = -21, 202 + 0.721 ^* Size - 0.639 ^* Age + 0.464 ^* Weight - 15,389 ^* Heart rhythm, where

Preferably, the global end diastolic volume hemodynamic parameter estimate may be calculated, the estimated value based on the patient's cardiac rhythm and / or catheter location, and at least one biometric parameter selected from size, age, weight, and sex is calculated. More preferably, the Global End-Diastolic Volume (GEDV) estimate is calculated based on patient size, age, weight, and heart rhythm, and catheter location.

In particular, preferably, the estimated value for calculating the indicated global end-diastolic volume may be calculated by the following formula:

GEDVcease = -1314,767 + 13,235 ^* Size + 8,808 * Age + 3,775 ^* Weight - 151, 178 ^* Sex + 70,716 ^* Heart rhythm -134,502 ^* Catheter location, where

Preferably, the estimate of the central venous oxygen saturation biochemical parameter (S _cv 0 ₂ ) may be calculated, the estimate being calculated based on a catheter location and / or arterial hematocrit and / or arterial oxygen saturation, and the patient's age.

Most preferably, the estimate of central venous oxygen saturation is calculated based on the patient's age, arterial hematocrit, and arterial oxygen saturation, and catheter location.

In particular, the estimate of central venous oxygen saturation may preferably be calculated by the following formula:

S _cv 0 ₂ cease = -60.85 - 0.151 * age- 2.493 ^* catheter location + 0.272 ^* arterial hematocrit + 1.445 ^* S _a 0 ₂ , where

S _cv 0 ₂ cease is the estimated value in% and the age in years, the catheter position assumes the value 1 when the catheter is inserted into the jugular vein or the subclavian vein, and assumes the value 2 when the catheter enters the femoral vein is used, the arterial hematocrit in% and the arterial oxygen saturation in%. The correction parameter may be biometric according to an alternative embodiment.

A method is also proposed for calculating an estimated value for at least one hemodynamic and / or biochemical parameter of a patient, which can be used in particular for indexing the hemodynamic and / or biochemical parameter, wherein the estimated value is based on at least one biometric parameter and and / or and at least the age and the magnitude, wherein the estimate indicates a value of the hemodynamic and / or biochemical parameter to be expected by the patient under given contexts.

Preferably, the estimated value for the hemodynamic parameter of cardiac output (CO) may be calculated, the estimate being calculated based on age, height, and weight. In particular, the cardiac output estimate is calculated by the following formula:

HZVcease = 0.899 + 0.052 * size - 0.085 ^* age + 0.033 * weight, where

HZVcease is the estimated value in L / min, the size in cm, the age in years and the weight in kg.

Preferably, the estimated value for the extravascular lung water hemodynamic parameter (EVLW) may be calculated, the estimated value being calculated by the following formula:

EVLWcease = -649,361 + 7,217 ^* size + 1, 635 ^* age, where

EVLWcease is the estimate in ml, which is in cm and the age in years.

The formula by which an estimated value for a hemodynamic parameter and / or biochemical parameter is calculated and / or a calculated estimated value and / or the at least one correction parameter and / or the at least one biometric parameter may preferably be stored in a database. The formula that computes an estimate of a hemodynamic parameter and / or biochemical parameter can be dynamically adjusted.

Based on the calculated estimated value for a hemodynamic parameter and / or biochemical parameter and a detected hemodynamic parameter and / or biochemical parameter of a patient, an indicated hemodynamic and / or biochemical parameter is preferably calculated.

In computing a plurality of estimates for indexing a plurality of hemodynamic and / or biochemical parameters, the at least one biometric parameter and / or the at least one correction parameter for calculating each of the plurality of estimates are selected such that a mathematical decoupling between the indicated hemodynamic and / or biometric parameters.

The advantages and side-effects described in relation to the method for indexing a hemodynamic and / or biochemical parameter are also given here. In particular, the explanations of the estimated value and the correction parameter in the description of the method for indicating a hemodynamic and / or biochemical parameter also apply to the estimated value and the correction parameter in the method for calculating an estimated value.

Claims

claims:

A method of indexing at least one hemodynamic and / or biochemical parameter of a patient comprising the steps of:

Detecting the at least one hemodynamic and / or biochemical parameter, and

2. The method according to claim 1, wherein the correction parameter comprises at least one data acquisition parameter which describes the boundary conditions of the data acquisition, in particular the data acquisition parameter results from the type of a used measurement technique and / or an individual pathology of the patient and / or an applied therapeutic measure.

3. The method according to any one of the preceding claims, wherein the correction parameter comprises at least one further hemodynamic and / or biochemical parameters.

4. The method of claim 1, wherein the correction parameter comprises at least one selection decision parameter via which additional expert knowledge is introduced into the calculation of the indicated hemodynamic and / or biochemical parameter.

5. The method according to claim 1, wherein the correction parameter comprises at least one patient group parameter via which a patient group is defined.

6. The method of claim 1, wherein a plurality of hemodynamic and / or biometric parameters are indexed and wherein at least one biometric parameter and / or at least one correction parameter are selected for indexing each of the plurality of hemodynamic and / or biometric parameters be achieved that a mathematical decoupling between the indicated hemodynamic and / or biometric parameters.

Method according to one of the preceding claims, wherein an estimated value is calculated on the basis of the detected hemodynamic and / or biochemical parameter, at least one biometric parameter and / or at least one correction parameter, the indicated hemodynamic and / or biochemical parameter being determined by dividing the detected hemodynamic and / or biochemical parameters. or biochemical parameter is calculated with the calculated estimated value, in particular the estimated value is calculated by a formula, wherein the at least one biometric parameter and / or the at least one correction parameter are weighted.

The method according to claim 1, wherein the hemodynamic parameter to be indexed is the stroke volume variation (SSV) and the indicated stroke volume variation based on the ventilation mode and / or the heart rhythm, and at least one of the selection of the hemodynamic parameter of the heart rate and the biometric parameters of the heart rate Age and weight of the patient.

The method of any one of claims 1 to 8, wherein the hemodynamic parameter to be indexed is central venous pressure (ZVD), and the indexed central venous pressure is based on the ventilatory mode and / or the heart rhythm, and at least one biometric parameter from the selection of the size, the age and weight of the patient.

The method of any one of claims 1 to 8, wherein the hemodynamic parameter to be indexed is stroke volume (SV), and the indicated heartbeat volume based on the heart rhythm and at least one biometric parameter from the selection of the size, Age and weight of the patient is calculated.

The method of any one of claims 1 to 8, wherein the hemodynamic parameter to be indexed is global end-diastolic volume (GEDV) and the indexed global end-diastolic volume is based on the cardiac rhythm of the patient and / or a catheter ply, and at least one biometric parameter from the selection of size, age, weight and sex is calculated.

12. The method of claim 1, wherein the biochemical parameter to be indexed is central venous oxygen saturation (S _cv 0 ₂ ) and the indicated central venous oxygen saturation based on a catheter location and / or arterial hematocrit and / or arterial oxygen saturation, and the age of the patient.

13. A method of indexing at least one hemodynamic and / or biochemical parameter of a patient comprising the steps of:

Detecting at least one hemodynamic and / or biochemical parameter, and

14. The method of claim 13, wherein the hemodynamic parameter to be indexed is cardiac output volume (HZV), and the indicated cardiac output is further calculated based on the weight, in particular the estimate for calculating the indicated cardiac output volume by the following formula is calculated:

HZVcease = 0.899 + 0.052 ^* size - 0.085 ^* age + 0.033 * weight, where

15. The method of claim 13, wherein the hemodynamic parameter to be indexed is extravascular lung water (EVLW) and the estimated value for calculating the indicated extravascular lung water is calculated by the following formula:

EVLWcease = -649,361 + 7,217 ^* size + 1, 635 * age, where EVLWcease is the estimate in ml, which is in cm and the age in years.

16. The method according to claim 1, wherein the at least one detected hemodynamic parameter and / or biochemical parameters and / or the at least one correction parameter and / or the at least one hemodynamic and / or biochemical parameter are stored in a database.

17. The method according to any one of the preceding claims, wherein the indexing of the at least one hemodynamic parameter and / or biochemical parameter takes place dynamically.

18. Data processing device comprising means for carrying out the method according to one of claims 1 to 17.

19. Computer program product comprising program parts which, when loaded in a computer, are designed to carry out a method according to one of claims 1 to 17.

20. A data carrier comprising the computer program product according to claim 19.