WO2007085110A1

WO2007085110A1 - O2-controller

Info

Publication number: WO2007085110A1
Application number: PCT/CH2007/000042
Authority: WO
Inventors: Josef Brunner; Marc Wysocki; Thomas Laubscher
Original assignee: Hamilton Medical Ag
Priority date: 2006-01-30
Filing date: 2007-01-30
Publication date: 2007-08-02
Also published as: JP2009524456A; US20080314385A1; EP1984051B1; US10561810B2; EP1984051A1; JP5290770B2; ATE479460T1; DE602007008838D1

Abstract

The invention relates to a device for the regulation of PEEP and FiO2 of a ventilator for achieving an arterial oxygen partial pressure in the blood of a mechanically ventilated patient. At reading which is representative of the success of the oxygen supply, i.e. the oxygen saturation of the blood is measured with the device, and assigned to one of three regions, which are defined by two characteristic lines. A first control loop is designed to optimise PEEP and FiO2 on assigning a reading to a region which demands a change of the settings, or to retaining the settings with an assignment to the normal region between the characteristic lines. This first control loop carries out such an optimisation at predefined temporal intervals on account of the representative reading (SaO2REP) and a predefined necessary supply intensity. The ventilator is subsequently activated accordingly. Therebetween, if necessary only FiO2 is increased or reduced with a second control loop, if between optimisations by way of the first control loop, the current representative value (SaO2REP) falls below a limit value (characteristic line) which is dependent on the supply intensity, which demands an immediate increase of the oxygen supply.

Description

O₂-CONTROLLER

Description:

The invention relates to a device and to a method for the regulation of a ventilator in accordance with the requirements of the patient, in particular of the end-expiratory pressure (PEEP) and the inspiratory oxygen concentration (FiO₂) in the ventilation gas, with the mechanical ventilation of a patient, as well as to a ventilator with such a regulation.

State of the art

The mechanical ventilation of a patient has the aim of keeping the CO₂-partial-pressure and the O₂-partial-pressure in the arterial blood of the patient to a level which is as normal as possible according to the circumstances. With the mechanical ventilation, one may influence the following factors: a) the ventilation volume by way of the ventilation frequency and the ventilation pressure, b) the lung volume taking part in the gas exchange, by way of the end-expiratory pressure (PEEP), c) the supply of oxygen by way of the oxygen concentration in the ventilation gas (FiO₂).

The enrichment of the blood with oxygen is influenced on the one hand in a negative manner by way of the so-called shunt, which is the blood which does not take part in the gas exchange, and on the other hand in a positive manner by the oxygen content of the ventilation gas. One may increase the lung volume participating in the gas exchange by way of increasing the PEEP. By way of this, the shunt may be reduced and the arterial oxygen partial pressure may be increased. The lung with each breath may be supplied with more oxygen by way of increasing the FiO₂. The arterial oxygen partial pressure in the blood may likewise be increased by way of this.

A method for providing sufficient alveolar ventilation is known from EP-A- 0 753 320 there is known. Since is not sufficient to supply oxygen and remove carbon dioxide, the document teaches the use of preferably only air with a low inspired oxygen concentration and the minimisation of any damage to the cardio-pulmonary system. To achieve this object, a minimal ratio between inspiration time and expiration time is sought and determined. An optimal respiration rate is then sought and determined. Furthermore, the opening and the closing pressure of the lung is then sought and determined by increasing and decreasing the applied pressure and analysing the partial oxygen

BESTATIGUNGSKOPIE pressure of the blood and comparing it with threshold values. The document teaches the ventilation above the closing pressure.

A distressed lung may be kept open by way of the suitable choice of the airway pressure above the alveolar closing pressure. US-6,612,995 B2 discloses a method for determining the alveolar opening or closing of a lung ventilated by an artificial ventilator, comprising the steps of:

- measuring one of the following values: Haemoglobin oxygen saturation, end-tidal CO₂-concentration in the expired gas and CO₂-output and

- changing the airway pressure, wherein the airway pressure level at which the alveolar opening or closing occurs is determined from the observation of the resulting course of the measured value, An apparatus for determining the alveolar opening or closing of a lung comprises

- an artificial ventilator,

- a sensor to measure the above-mentioned value, and

- a data processor which, during the change of the airway pressure, determines the airway pressure level at which the alveolar opening and closing occurs, from the resulting course of the measured value.

With a general setting of a PEEP, with which an as large as possible lung volume participates in the gas exchange, one however does not react to the particularities specific to the patient in an optimal manner. For an optimal setting of the parameters influencing the oxygen supply, an increase of the PEEP on the one hand, and an increase of the FiO₂ on the other hand are to be weighed up against one another. Both parameters are to be regulated in a patient-specific manner for optimising PEEP and FiO₂. Thereby, one should particularly take into account the fact that not so high PEEPs are possible with haemodynamically instable patients than with haemodynamically stable patients.

Object of the invention

It is the object of the invention to provide a device and a method, with which the settings of a ventilator are capable of being automatically set in a patient-specific manner.

This object is achieved according to the invention, in that the device for the regulation of settings of a ventilator for achieving an adapted, mechanical ventilation of the patient comprises at least the following: at least one sensor, preferably at least two sensors, specifically at least one sensor for the continuous measurement or for the measurement in temporal intervals at least of a reading representative of the success of the supply of the O₂ supply and/or at least one sensor for the continuous measurement or measurement in temporal intervals of at least one reading representative of the success of the ventilation, a programmed computer,

- which is provided with at least one first electronic control loop functioning in a long- term manner, specifically a control loop in order to optimise PEEP and FiO₂, and/or a control loop in order to optimise P_msp and RRM_V, on account of the representative reading and a predefined necessary ventilation intensity, and said computer being programmed in a manner such that the ventilator in each case is activated according to the current optimisation, and

- which is equipped with at least one second electronic control loop functioning in a short-term manner, specifically, a control loop, in order between the optimisations by way of the first control loop, if necessary, to increase the FiO₂ on account of the current representative value, and/or a control loop in order between the optimisations by way of the first control loop, if necessary, to increase the ventilation on account of the current representative value.

This provision with a control loop functioning in a long-term manner, and a control loop functioning in a short-term manner, for the regulation of the ventilation and/or the O₂ supply, on the one hand permits an optimisation which is adapted over the long term to the requirements of the patient. This reduces the risk of a damage to the lungs. However, one ensures that short-term requirements of the patient are taken into account.

In a preferred embodiment, an oxygen sensor for checking the oxygen supply of the patient, in particular the oxygen saturation in the blood of the patient, as well as a CO₂ sensor for checking the ventilation, in particular the arterial CO₂-partial-pressure of the patient, and all four control loops are present.

It is particularly the object of the invention to suggest a device and a method, with which the PEEP- and FiO₂-settings of a ventilator are capable of being regulated in accordance with the patient.

According to the invention, this object is achieved by the independent claims. The dependent claims define advantageous embodiments of the invention.

A device according to the invention for the control of the PEEP- and FiO₂-settings of a ventilator, in order to achieve an adapted arterial oxygen-partial pressure in the blood of a patient mechanically ventilated with the ventilator, comprises at least one oxygen sensor, e.g. a pulsoximeter, and a programmed computer. The oxygen sensor serves for the measurement of at least one reading (SaO₂ ¹^) which is representative for the success of the oxygen supply. This measurement is effected in a continuous manner in temporal intervals.

The programmed computer is equipped with a first electronic control loop, in order to optimise PEEP and FiO₂ on account of the representative reading (SaO₂ ¹^) and a predefined necessary supply intensity. It is furthermore programmed in a manner such that it repeats such an optimisation in predefined temporal intervals, and that the ventilator in each case is activated accordingly. It is furthermore equipped with a second electronic control loop, in order between the mentioned optimisations which are carried out with the first control loop, if necessary, to change FiO₂ on account of the currents representative value

Such a device permits a short-term adaptation of the oxygen supply on the one hand to the requirements of the patient, and a long-term optimisation of FiO₂ and PEEP on the other hand. The optimisation OfFiO₂ and PEEP requires longer intervals, in order to be carried out efficiently, and reduces the risk of a damage to the lung. The adaptation of FiO₂ by the second control loop ensures that such a relatively long interval may not lead to an undersupply of the patient with oxygen.

With the optimisations, either only PEEP or only FiO₂ may be adapted. Usefully then, the length of the interval is dependent on which of these parameters was adapted with a preceding optimisation. Advantageously however, in each case an optimised PEEP as well as an optimised FiO₂ is computed and simultaneously set.

In order to fulfil its task of the optimisation of PEEP and FiO₂, the first control loop usefully contains two algorithms. The first of these two algorithms serves for the computation of a necessary supply intensity. It computes such a value on account of the current representative reading (SaO₂ ¹^) and the current supply intensity. The second algorithm serves for determining the individual values for PEEP and FiO₂. These are then computed on account of the necessary supply intensity. A function (including the value) of PEEP, a function (including the value) OfFiO₂, or a function of PEEP and FiO₂ may be taken as the supply intensity.

A computation of the individual values for PEEP and FiO₂ on account of the supply intensity advantageously results in different results depending on the requirements that a patient brings along. For this reason, a device should have input possibilities for the lung condition, a strategic goal of the ventilation, the haemodynamic stability and possible the age of the patient. The results on computation of the setting values are also influenced by these inputs.

In any case, the setting must ensure an O₂-supply. With the device therefore, the first control loop, in particular the first algorithm assigns, assigns the representative reading in each case to one of three regions. These are the regions: "too high a reading", "normal reading", "too low a reading". These regions are defined by at least two characteristic line pairs stored in a memory. Advantageously, two characteristic line pairs are stored for different strategies. Each characteristic line pair has a first characteristic line which assigns in each case different minimal representative values to different quantified supply intensities. This characteristic line therefore forms the border line between the normal region and the region which is too low. The characteristic line pair of course also has a second characteristic line, which assigns in each case different maximal representative values to different quantified supply intensities. This second characteristic line is therefore the border line between the normal region and the region for readings which are too high. Both characteristic lines are distanced to one another and between them, define the normal region for the representative value. Two characteristic lines are present for the first control loop. Two characteristic lines may likewise be present with the second control loop. The characteristic lines of the first control loop are then arranged at a first, smaller distance to one another, with the second control loop however at a second larger distance to one another. The second control loop may only have one lower characteristic line. This means that with the second control loop, the upper characteristic line lies at 100% FiO₂, and therefore may not be exceeded. The normal region which is applicable to the first control loop, in any case falls completely in the larger normal region which is applicable to the second control loop. If the representative reading falls in this normal region, then the settings of the ventilator which concern the supply with oxygen, are retained. If the reading falls into the normal region of the first control loop, then it compellingly also falls in the normal region of the second control loop. Since the normal region of the second control loop is wider than that of the first control loop, the second control loop may only become effective when, between the adaptations of the settings by way of the first control loop, the reading moves so far out of the normal region of the first control loop, that it also goes out of the normal region of the second control loop. The second control loop therefore reacts in a more tolerant manner, but in a shorter interval than the first control loop.

If thanks to the increase Of FiO₂ by way of the second control loop, the reading lies within the normal region of the second control loop, then it may despite this lie outside the tighter normal region of the first control loop. The first control loop the next time will therefore again have to carry out the optimisation afresh, and, if the condition of the patient permits this, increase PEEP in many cases, in order to achieve an optimisation of PEEP and FiO₂. Thereby, the first control loop may base its computation on the supply intensity resulting after the correction by the second control loop. Advantageously however, such a change by the second control loop is not taken into account, but the computation is based on the intensity which results from the settings set by the first control loop.

The three regions are advantageously defined depending on a strategic goal. Different characteristic line pairs are therefore stored in the memory. Different characteristic line pairs represent a forced withdrawal or a normal ventilation with a tendential withdrawal. Therefore a strategic goal may advantageously be selected with the device. The first algorithm then falls back on a different characteristic line pair corresponding to the strategic goal, depending on the selected strategic goal. Depending on whether the current reading with the applied characteristic line pair, still lies within the normal region or not, accordingly at least one of the two parameters PEEP and Fiθ₂, or both simultaneously, are changed, and thus also the intensity is changed. The characteristic lines lie differently with another characteristic line pair, so that the change of the two parameters does not happen in the same situation. A strategic goal may be followed up by way of this.

The device further usefully has an input possibility for a patient parameter characterising the lung condition of the patient. The patient parameter is then taken into account in the second algorithm of the first control loop. A change of the parameter may therefore influence the individual values for the supply parameters.

Usefully, in a similar manner, an input possibility for a haemodynamic input value is provided, which characterises the haemodynamic stability of the patient. This haemodynamic input value is taken into account in the second algorithm, in order with the optimisation of FiO₂ and PEEP to ensure that the selected end-expiratory pressure does not burden the haemodynamics too much. The haemodynamic input value may be inputted manually, or however may be evaluated automatically on account of a blood pressure monitoring, or a monitoring of another value indicating the haemodynamics. An automatic switch-over to a mode for haemodynamically instable patients is effected on account of this value, for example on account of the average blood pressure (e.g. the patient is classed as being haemodynamically stable at a blood pressure for example of more than 65mmHg).

If this value indicating the haemodynamics is so bad, that one is to assume haemodynamics which may not be burdened any further, e.g. thus with an average blood pressure of 65 mmHg or lower, then a controller is automatically switched on, which ensures that the oxygen concentration FiO₂ is increased instead of a PEEP increase. This controller furthermore checks as to whether a value indicating the haemodynamics is present, which permits this decision. In the case that no value indicating the haemodynamics is present, the controller increases PEEP in only two cases, specifically when the current PEEP does not lie above 5 CmH₂O, and when a good circulation is present, which is ascertained with the pulsoximeter, and PEEP lies maximally at 10 cmH₂0. If these conditions are not fulfilled, and there is no new value indicating the haemodynamics as a basis, the controller gives the apparatus user the decision as to whether PEEP or FiO₂ is to be increased.

With the optimisation of PEEP and FiO₂ with the first control loop, usefully one applies functions, with which the lung condition and the haemodynamics of the patient may be taken into account. Therefore different, diagrammatically representable functions are deposited in a memory at the device. These functions in each case allocate a value for PEEP to a value for FiC>₂. The second algorithm on account of one of these functions, determines the current values for PEEP and FiO₂, or whether FiO₂ and/or PEEP must be increased or reduced.

The second algorithm selects the fitting function according to the inputted input values. One function which is applied with instable haemodynamics, advantageously assigns FiO₂ and PEEP to one another, irrespective of whether the supply intensity is increased or reduced. One function which on the other hand is applied with stable haemodynamics, forms a loop and therefore assigns FiO₂ and PEEP to one another depending on whether the supply intensity is increased or reduced. Tendentially, with a reaction of the necessary intensity, firstly FiO₂ is reduced, but with a necessary increase of the intensity however, tendentially firstly PEEP is increased, or PEEP and FiO₂ are increased alternately or simultaneously.

Advantageously, the computer is programmed such that a so-called recruitment manoeuvre is carried out before increasing the PEEP, in order after the recruitment manoeuvre to artificially respirate with the incresed PEEP. Such a recruitment manoeuvre may be carried out for example by way of ventilating in the CPAP-mode for 30 seconds with 40cmH₂O and without pressure support. Lung parts which are not ventilated are to be opened by way of this, which are then to be kept open with the increased PEEP.

Since such a device regularly controls the ventilations via the ventilation rate and the ventilation pressure, as well as the oxygen supply via FiO₂ and PEEP, the invention may also be described as follows. The device for the regulation of the settings of a ventilator has sensors for monitoring the success of the ventilation and of the oxygen supply. It further comprises a programmed computer for activating the ventilator with the purpose of the regulation of the ventilation and of the oxygen supply on account of the sensor signals. Four control loops are programmed in the computer, specifically:

1. A first ventilation control loop, in order to set the target frequency and the inspiration pressure in accordance with the patient. A target value for the intensity of the ventilation and a target value for the arterial CO₂-partial-pressure of the patient and corresponding to present intensity of the ventilation are kept within limits with these settings. The first ventilation control loop effects a long-term regulation of the ventilation settings.

2. A second ventilation control loop, in order, in a temporally limited manner, to reduce the target value for the arterial CO₂-partial-pressure and to increase the target value for the ventilation intensity. This however is only to be effected when the total respiratory frequency exceeds the computed target frequency (for a certain time duration) by a certain value. This second ventilation control loop effects a short-term correction of the ventilation settings for relieving the patient who demands a lower CO₂-ρartial- pressure by way of his own increased activity.

3. A first O₂-suρply control loop in order to set the oxygen concentration of the ventilation gas, and the end-expiratory pressure, and thus to achieve a target value for the oxygen supply of the patient. This first O₂-supply control loop effects a long-term optimisation of PEEP and FiO₂.

4. A second O₂-supply control loop, in order merely to increase the oxygen concentration in the ventilation gas between two optimisations by way of the supply control loop, as soon as a representative reading for the success of the oxygen supply falls below a limit value. This second O₂-supply control loop effects a short-term securing of an adequate oxygen supply.

Such a device is preferably a constituent of a ventilator. Advantageously, the ventilator has a sensor for checking the success of the oxygen supply, a sensor for the control of the haemodynamic stability of the patient, and a computer with input possibilities for the haemodynamic stability of the patient, for the input of a patient parameter, as well as a strategic goal. Advantageously, the haemodynamics and the oxygen supply is monitored with the same sensor. The computer is programmed in order to automatically compute PEEP and FiO₂ on account of the sensor values and the input values and to regulate the settings of the ventilator accordingly.

The method according to the invention for the regulation of PEEP and FiO₂ of a ventilator serves for achieving an arterial oxygen partial pressure in the blood of a patient being mechanically ventilated. It operates with two control loops: With a first control loop, in the span of a first interval, the values of PEEP and FiO₂ are optimised and the ventilator is activated accordingly. After a change, the interval is e.g. 90 sec to 3 min, until a new operation is computed. The interval is advantageously shorter (90sec) with an increase of the supply, than with a reduction of the supply intensity (180 sec). This first control loop, for this; is based on a value (SaO₂^¹") which is representative of the oxygen content (saturation) of the arterial blood, and a necessary predefined supply intensity. If necessary, FiO₂ is increased in the span of a second, shorter interval (e.g. 15 seconds) with a second control loop. The second control loop thereby is based on the representative value (SaO₂ ^mP). FiO₂ is brought very rapidly, as the case may be, to 100%, by way of the second control loop. Advantageously, straight away, one enriches with 100% oxygen with an increase of the oxygen content in the ventilation air. On reducing the oxygen content, because the saturation has become sufficient after the increase, this increase is again reduced to 90% within a short time (3 minutes).

The representative value is usefully a continuously measured reading which e.g. is representative of the oxygen saturation of the blood. Even if invasive methods were also to be possible, non-invasive measurement methods are preferred, so that the representative value is preferably acquired with a pulsoximeter. The representative value may be deduced from a measurement with a single sensor. It may however also be summarised from different readings of several sensors, which increases the reliability of the reading.

The representative value may also be computed from a CCVbalance of the respiratory gases, if one may apply a blood gas measurement.

The first control loop is advantageously divided up into two algorithms. A necessary supply intensity (function of PEEP) is computed with a first algorithm on account of the representative value and of the current supply intensity. The individual values for PEEP and FiO₂ are evaluated with a second algorithm on account of the necessary supply intensity. Usefully, a patient parameter which characterises the lung condition is characterised in a second algorithm.

The first algorithm of the first control loop assigns the representative value advantageously in each case to one of three regions. A correction of the setting therefore needs only to be effected when the representative value lies outside a normal region. The second control loop assigns the representative reading to one of two regions. It initiates a correction of the FiO₂-setting, in the case that the reading is so low that it no longer falls in the normal region, and therefore displays an insufficient oxygen supply. These regions are defined in the first control loop by two characteristic lines which are distanced to one another, and which in each case assign a supply intensity to a minimal and maximal representative value. Between them, they define a normal region for the representative value. Only a lower characteristic line is fixed in the lower control loop, and this line defines that the second control loop is activated when the reading falls below this characteristic line. The lower characteristic line for the minimal representative value, with the second control loop, lies lower than with the characteristic line pair used in the first control loop. Analogously, the upper characteristic line for the maximal representative value, in the first control loop, lies below the maximal reading of 100% of the second control loop.

Usefully a haemodynamics input value which characterises the haemodynamic stability of the patient is taken into account in the second algorithm of the first control loop. With instable haemodynamics, the maximal end-expiratory pressure PEEP is limited to such a depth, that practically only the oxygen concentration of the ventilation air continues to be adapted.

The second algorithm determines the current values for PEEP and FiO₂ advantageously on account of a diagrammatically representable function. The function in each case allocates a value for PEEP to a value for FiO₂. The second algorithm uses different functions, depending on what current haemodynamic input value, and what current patient parameter is present, in order to fix the values of Fiθ2 and PEEP.

With instable haemodynamics, the function assigns FiO₂ and PEEP to one another, independently of whether the supply intensity is increased or reduced.

With stable haemodynamics on the other hand, the function forms a loop. For this reason, FiO₂ and PEEP are assigned to one another depending on whether the supply intensity is increased or reduced.

These diagrammatically representable functions are advantageously configurable according to wishes. They may therefore be configured and modified according to new information or according to personal convictions of physicians. For this, one may for example determine 10 points, between which the diagrammatically represented function runs in a straight line. These points may be displayed and set in an infinite manner or within limits.

An adaptation of PEEP and FiO₂ is effected after each time interval of Δt, as long as the readings lie below the normal region. Thereby, for example PEEP is increased by 2 cmH₂O (a recruitment manoeuvre is carried out for this) and FiO₂ is fixed by way of the currently applicable function. If the haemodynamics are capable of being monitored during the recruitment manoeuvre, then the recruitment manoeuvre may be terminated as soon as signs for instable haemodynamics are observed.

With a reduction of the intensity, accordingly PEEP is reduced by 2cmH₂O and FiO₂ is adapted according to the valid function. This is repeated until the reading SaO₂ lies within the normal region.

The second algorithm, with a necessary intensification of the supply, usefully on account of an assessment of the blood pressure or of another reading which provides information on the haemodynamics of the patient, decides as to whether PEEP may be increased to the required extent and whether only FiO₂ may be increased.

Advantageously, different characteristic line courses form the basis of the second control loop depending on a patient parameter. This permits the characteristic lines and therefore the normal region to be adapted to the requirements specific to the patient or specific to the disease, but above all to the strategic goals.

Furthermore, the present invention may be defined as a method for the automatic regulation of the settings of a ventilator, with which method the following steps are carried out: with a first ventilation control loop, the target frequency and the inspiration pressure are set, in order to fulfil target values for an arterial CO₂-partial-pressure in the patient blood and for a ventilation intensity, in accordance with the patient.

By way of a second ventilation control loop, for a limited time, the target value for the arterial CO₂- partial-pressure is reduced, and the target value for the ventilation intensity is increased. This however only occurs when the total respiratory frequency exceeds the computed target frequency by a certain value. With a first O₂-supρly control loop, the oxygen concentration of the ventilation gas, and the end- expiratory pressure are set, in order to fulfil target values for the supply intensity and an oxygen concentration in the patient blood, in accordance with the patient.

And finally, the oxygen concentration in the ventilation gas is increased by way of a second supply control loop. This increase only occurs when a representative reading (SaO₂ ¹^) for the oxygen concentration between two settings by way of the supply control loop in the patient blood falls below a certain lower limit value, said limit value lying below the normal region of the first control loop.

The invention also relates to a ventilator with a control which is designed in order to carry out one of the above described methods.

Such a ventilator is provided with a sensor for measuring a reading which is representative of the oxygen partial pressure, a sensor for the monitoring of the haemodynamic stability, a programmable control with input possibilities for haemodynamic stability of the patient, for the input of a patient parameter, and for the automatic computation and activation of a PEEP and a FiO₂ whilst taking these input values into account.

The invention is hereinafter explained in detail by way of examples and the Figures.

Fig. 1 schematically shows the regulation of the oxygen supply of a patient with a ventilator.

Fig. 2 shows a diagrammatically represented function curve for adapting FiO₂ and PEEP with an increase or reduction of the necessary supply intensity for normal patients, x-axis PEEP, y-axis FiO₂

Fig. 3 shows a diagrammatically represented function curve for adapting FiO₂ and PEEP with an increase or reduction of the necessary supply intensity for patients with a stiff lung and/or with a high ventilation resistance in comparison to the function of the normal patients x-axis PEEP, y-axis FiO₂ Fig. 4 shows a diagrammatically represented function curve for adapting FiO₂ and PEEP with an increase or reduction of the necessary supply intensity for haemodynamically instable patients, in comparison to the function for normal patients, x-axis PEEP, y-axis FiO₂

Fig. 5 shows characteristic lines for the assessment of a representative value for the arterial oxygen partial pressure in the blood of the patient, x-axis supply intensity, y-axis representative value SaO₂ ¹^¹"

Fig. 6 shows a schematic representation of a ventilator with control loops for the ventilation and the oxygen supply.

The diagram represented in Figure 5 schematically shows a circuit with which the method according to the invention may be used with the supply of a patient 11 with oxygen.

The oxygen is supplied to the patient 11 by way of a pressure source (ventilator) 13 with the ventilation air 15. The pressure source 13 is controlled by a circuit. The circuit consists of a first control loop 17 and of a second control loop 19, which both ensure an adequate oxygen supply. The first control loop comprises two algorithms, specifically a first algorithm 21 which defines the necessary supply intensity, and a second one 23 which evaluates the suitable setting with regard to FiO₂ and PEEP and activates the ventilator 13 accordingly.

The product of FiO2 (%) and PEEP (CmH₂O) may be defined as the supply intensity. The supply intensity then with a PEEP below 1 is always 1 * FiO₂. With a supply intensity which is defined as a linear function of FiO₂ and PEEP, however a change of PEEP is weighted too little in comparison to a change OfFiO₂. It is therefore useful, in order to better reflect the intensity of the ventilation in this value, to increases the weighting of PEEP, or in a simplifying manner, to even not take FiO₂ into account at all with a definition of the supply intensity. In the latter case, the supply intensity is a function of PEEP alone. This necessary supply intensity, also called "treatment level", is fixed for the patient 11 in the first algorithm 21 of the first control loop 17. The basis for this fixing is an input of a patient parameter 25. The following circumstances are differentiated with the patient parameters:

• normal patients,

• COPD-patients with an increased lung resistance compared to normal patients

• AKDS-patients with an increased lung stiffness compared to normal patients,

• patients with haemodynamic instability,

• patients with brain injury. Furthermore, a strategic differentiation is made between normal operation (with tendential withdrawal) and forced withdrawal. The input of this strategic goal is indicated with the reference numeral 26.

One uses different characteristic lines 27, 29 with an assessment of the arterial oxygen partial pressure, depending on the strategy. These characteristic lines 27, 29 are represented by way of example in Figure 5. The supply intensity increases from the left to the right on the X-axis, and the Y-axis contains the values for the representative value for the oxygen partial pressure in the blood, increasing to the top. Several characteristic line pairs are present, which in each case assign a minimal and a maximal value of the representative value to a supply intensity. The characteristic line pairs are differentiated from one another in the drawing by way of different line qualities. The characteristic lines shown in an unbroken manner apply to the first control loop, the interrupted characteristic lines apply to the second control loop.

The characteristic line pairs run differently, depending on which strategic goal is followed, and whether they apply to the first or second control loop. With a strategy for the forced withdrawal, the applicable normal region has lower values for the arterial oxygen saturation than the normal region, which is applicable with a strategy for normal ventilation.

On this basis, a representative value, in the represented embodiment example, a representative reading for the saturation of the blood SaO₂^¹" measured with a pulsoximeter, is classed into one of the three regions 31, 33, 35 defined by the characteristic lines. The reading is therefore graded either as normal when it falls in the region 33, as too high when it falls in the region 35, or as too low when it falls in the region 31.

If a current representative value falls between the characteristic lines of the currently applicable characteristic line pair, then it is considered as normal and the ventilation is continued in an unchanged manner. If the current value however falls below the lower characteristic line 27 or above the upper characteristic line 29, then the supply intensity is increased or reduced respectively.

The new values for the supply intensity together with an input value 37 for the haemodynamic stability of the patient, forms the basis for the measurement of PEEP and FiO₂. It is decided by way of functions which are schematically represented in the Figures 2 to 4 as to whether PEEP or FiO₂ are to be increased or reduced. With normal patients, the PEEP is firstly increased with an increasing supply intensity. Later either PEEP or FiO₂ or both together are increased. PEEP is never lifted above the limit value defined by the curve. From a certain supply intensity, PEEP as well as FiO₂ are increased, until one ventilates with pure oxygen. Thereafter, it is only the end-expiratory pressure PEEP which is still increased. Tendentially however , firstly the oxygen component in the ventilation air is reduced. The oxygen component is reduced until the returning curve of the function is intersected. This curve runs from the most extreme corner with the highest supply intensity steeply back to a supply with a low oxygen component in the ventilation gas. Up to this, the PEEP is only slightly reduced. From this point, the ventilation pressure and the oxygen content are reduced symmetrically. Finally, one ventilates with an oxygen content of 30%, and for this reason only PEEP can still be reduced.

With the function for COPD- and ARDS-patients (Fig. 3), one increases from the same supply level of PEEP and Fiθ₂ in a proportional manner up to their extreme values. With the reduction of the supply intensity, the curve firstly runs identically to the curve for normal patients. For this reason, it is chiefly the oxygen content which is reduced, and the PEEP is only slightly reduced. The curve retains this direction until an FiO₂ of 30%. After this, solely PEEP is reduced.

If under certain circumstances, an automatic evaluation of PEEP and FiO₂ may not be based on readings and programmed in a secure manner, which may be the case e.g. for PEEP in the case of a COPD patient, the device is programmed in a manner such that the respective value must be inputted in a manual manner.

With patients with instable haemodynamics, PEEP is only changed according to Figure 4 in a region of 0 to 5 mbar. In this region however, the oxygen content of the ventilation gas is greatly increased with an increase in the supply intensity. On taking down the supply intensity, the second algorithm follows the same curve as with the intensification. Since an increased PEEP represents a burden to the heart, one mainly reacts with FiO₂ with haemodynamically instable patients.

A ventilator is represented diagrammatically in Figure 6. This Figure also contains the diagram represented in Figure 1. The first O₂-supply control loop 17 has both algorithms 21 and 23 which in a longer interval weigh up FiO₂ and PEEP against one another and optimise these over the longer term. A second supply control loop 19, if required, in the meanwhile increases the FiO₂, in order in the short term to ensure the oxygen supply of the patient.

Apart from this, a regulation is present in order to ensure the ventilation of the patient. This regulation has a first ventilation control loop 39 with the algorithms 41 and 43. The first algorithm 41 computes a new ventilation intensity on account of a present ventilation intensity and a current representative reading PaCO₂ ¹*^ for the arterial CO₂-partial-pressure of the patient. This newly evaluated value forms the basis of the second algorithm. On this basis, it computes a target frequency RR^sp, machine frequency RRIMV* and an inspiration pressure Pj_nSp. The target frequency is compared to the current, total respiratory frequency in a second ventilation control loop 45. If the patient breathes actively by a certain amount more frequently that corresponds to the target frequency, then the ventilation intensity is increased by way of the second ventilation loop 45, and the target value for PaCO₂ ^REP is reduced. This measure is based on the assumption, that the patient desires a lower CO₂-partial-pressure and thus increases the frequency. As soon as the total respiratory frequency RR_tot and the target frequency RR^sp correspond to one another over a certain time, e.g. 10 minutes, an intensification of the ventilation initiated by the second ventilation control loop 45 is cancelled again.

The ventilation of the patient is carried out by the mechanical ventilation unit 13 according to the values for the inspirational pressure and the ventilation rate which have been deduced with the first and the second ventilation control loop. The oxygen supply is carried out by the mechanical ventilation unit 13 according to the values FiO₂ for the oxygen content of the respiratory gas and PEEP for the remaining end-expiratory pressure. The patient 11 therefore obtains the predefined ventilation. The pressures on breathing in and out are measured at the proximal flow sensor 51. Different parameters which are monitored by the apparatus are computed therefrom.

Furthermore, a block E is represented, which indicates an interface, with which those monitoring values which form the basis of the ventilation and the oxygen supply, are controlled (e.g. plausibility check) and are processed into bases for the control loops 39 and 17.

Block G indicates that the monitoring values SpO₂, pulse, PaCO₂, tcpCO₂, mABP etc. may also come from an external monitoring apparatus G, and does not necessarily need to be fed directly from a sensor into the block E.

Furthermore, the blocks A, B, C, D and a block H connecting these is represented. The blocks A to D indicate the manual input possibility of certain settings.

A: Manual input of blood pressure and blood gas values.

B: Input of ventilation strategies, disease parameters, size and sex of the patient, said values forming a basis on evaluation of the specific values for the oxygen supply and the ventilation. C: Adaptation or manual setting of all setting values. D: Manual setting of alarm limits, pure oxygen ventilation, or carrying out manoeuvres such as suctioning, etc..

Block H indicates the user interface with a screen display, via which interface all these input possibilities are capable of being used, and on which the set values and the measured values are represented. The interface according to block E processes a representative value from a series of readings and indexes these with an index for its reliability. For this reason, the oxygen saturation of the blood may for example be measured simultaneously with two independent sensors, e.g. two pulsoximeters, a pulsoximeter and breathing gas sensors, etc. The readings Spθ2 and PawO₂ and PawCO₂ provided by the sensors are then (e.g. whilst taking a blood gas measurement into account) summarised into the representative value SaO₂ ¹^¹".

The same also applies to PaCO₂. The value of the end-tidal CC>₂-measurement is taken as a representative value PaCO₂ ¹^.

The average arterial blood pressure mABP is either evaluated from invasive measurements or non-invasive measurements of the blood pressure. Other readings which provide information on the haemodynamics (e.g. perfusion index) may be deduced from the measurement results of the pulsoximeter.

The device regulates the settings of the ventilation parameters of respiratory pressure, P^_p, respiratory rate RjRIMV, inspiration time TI, oxygen concentration in the respiratory gas FiO₂, and the end-expiratory pressure PEEP in a manner such that the representative readings PaCO₂ ¹^ and SaO₂^ fall in a normal region. If a reading falls in the normal region, then the setting mostly remains unchanged. A change is only carried out when the spontaneous rate lies above the computed target rate by a certain amount. If the representative reading does not fall in the normal range which is defined depending on the supply intensity or depending on the intensity of the ventilation, the ventilation parameters are changed. With a change, patient parameters such as lung condition (compliance, resistance, COPD, ARDS), haemodynamic stability, brain injury, patient activity, age etc. are taken into account, e.g. by way of corresponding functions or the selection of normal regions. With an oxygen supply which is too low, the PEEP may be increased as the case may be. A recruitment manoeuvre is carried out with an increase of the end-expiratory pressure, in order thereafter to artificial respirate with the increased PEEP. A PEEP- increase however is only carried out to a low extent with haemodynamically instable patients, and thereby, such a recruitment manoeuvre may be done away with.

Concluding, the invention relates to a device for the control of PEEP and FiO₂ of a ventilator for achieving an arterial oxygen partial pressure in the blood of a mechanically artificial respirated patient. At least one reading which is representative of the success of the oxygen supply, i.e. the oxygen saturation of the blood, is measured with the device in a continuous manner or at intervals, and assigned to one of three regions, which are defined by two characteristic lines. Two of the three regions demand a reduction or an increase of the supply by way of an adaptation of the settings, a third, specifically a normal region between the characteristic lines, permits the retention of the given settings. A first control loop is designed to optimise PEEP and FiO₂ on assigning a reading to a region which demands a change of the settings, or retain the settings with an assignment to the normal region. This first control loop carries out such an optimisation at predefined, temporal intervals on account of the representative reading (SaCb^¹") and a predefined necessary supply intensity. The ventilator is subsequently activated accordingly. Within these temporal intervals, i.e. between two optimisations of the first control loop, if necessary, only FiO₂ is increased with a second control loop, if between optimisations by way of the first control loop, the current representative value (SaO₂ ¹^) falls below a limit value (characteristic line) which is dependent on the supply intensity and which demands an immediate increase of the oxygen supply, and reduced with the second control loop, if the current representative value (SaO₂ ¹^) is above said limit value again.

Claims

Patent claims

1. A device for the regulation of PEEP- and FiC>₂-settings of a ventilator for achieving an adapted, arterial oxygen level in the blood of a patient mechanically ventilated with the ventilator, comprising:

- an input means for delivering at least one reading (SaO₂^) representative of the success of the oxygen supply derived from a continuous measurement or from a measurement in temporal intervals,

- a programmed computer in order to determine values for PEEP and FiO₂, characterised in that the programmed computer is designed in order to determine a necessary supply intensity, is designed with a first electronic control loop, in order to weigh up PEEP and FiO₂ against one another and optimise them on account of the representative reading (SaO₂ ¹^) and the necessary supply intensity, and is programmed in a manner such that this first control loop is repeated in temporal intervals and the ventilator in each case is activated accordingly, and is designed with a second, electronic control loop, in order between the optimisations by way of the first control loop, if necessary, to increase FiO₂ in the short-term, on account of the current representative reading (SaO₂ ¹^) alone.

2. A device according to claim 1 , characterised in that the supply intensity is a function of the PEEP.

3. A device according to claim 1 or 2, characterised in that the supply intensity is a function OfFiO₂.

4. A device according to one of the claims 1 to 3, characterised in that the oxygen sensor is a pulsoximeter.

5. A device according to one of the preceding claims, characterised in that the first control loop contains two algorithms, specifically a first algorithm, in order to compute a necessary supply intensity on account of the current representative reading (SaO₂ ¹^) and the current supply intensity, and a second algorithm, in order to evaluate the individual values for PEEP and FiO₂ on account of the necessary supply intensity.

6. A device according to claim 5, characterised by an input possibility for a patient parameter characterising the lung condition of the patient, and by way of the fact that the patient parameter is taken into account in the second algorithm, so that a change of this patient parameter leads to a different optimisation of PEEP and FiO₂.

7. A device according to one of the preceding claims, with which the first control loop in each case assigns the representative reading (Saθ₂ ^REP) to one of three regions which are defined by a characteristic line pair, and only carries out a change of the parameters Fiθ₂ and/or PEEP when the reading lies outside a middle normal region, wherein the characteristic line pair has a first characteristic line which assigns in each case different minimal representative values (SaO₂ ¹^) to different, quantified supply intensities, and a second characteristic line which assigns in each case different maximal representative values (SaO₂^¹") to different quantified supply intensities, said both characteristic lines being distanced to one another and between them defining the normal region for the representative value (SaO₂^¹"), and the second control loop assigns the representative reading (SaO₂ ¹¹^) in each case to one of two regions which are defined by a single characteristic line, and only carries out a change of the parameter FiO₂ when the reading lies below the characteristic line, wherein the characteristic line in each case assigns different minimal representative values (Saθ₂ ^REP) to the different, quantified supply intensities, and wherein the characteristic line used in the second control loop lies below the lower characteristic line of the characteristic line pair used in the first control loop, and the normal region which is used with the first control loop falls completely within the normal region present above the characteristic line with the second control loop.

8. A device according to claim 7, characterised in that different characteristic line pairs for the first control loop and different characteristic single lines for the second control loop are stored in a memory and are selectable.

9. A device according to claim 8, characterised in that a strategic goal is selectable, and the computer, depending on the selected strategic goal, selects different characteristic line pairs and single lines corresponding to the strategic goal.

10. A device according to one of the claims 1 to 9, characterised in that a controller is present, which on account of the current PEEP and at least one value indicating the haemodynamics of the patient, i.e. the blood pressure or a reading which is a measure of the peripheral circulation, decides whether a PEEP- increase demanded by the first control loop is carried out, or FiO₂ is increased instead of the suggested PEEP-increase, or the decision is left to the user of the device.

11. A device according to one of the claims 5 to 10, characterised by an input possibility for a haemodynamic input value which characterises the haemodynamic stability of the patient, and by way of the fact that the haemodynamics input value is taken into account in the second algorithm on optimising FiO₂ and PEEP.

12. A device according to one of the claims 5 to 11, characterised by different functions which may be represented diagrammatically, are stored in a memory and in each case assign a value for PEEP to a value for FiO₂, and by way of the fact that the second algorithm determines the current values for PEEP and FiO₂ on account of one of these functions.

13. A device according to claim 12, characterised in that the second algorithm is programmed such that the function on which the algorithm is based, is selected depending on an input representing the haemodynamic status of the patient, and on the current patient parameter.

14. A device according to claim 11, characterised by a function which is applied with instable haemodynamics, said function assigning FiO₂ and PEEP to one another independently of whether the supply intensity is increased or reduced.

15. A device according to claim 13, characterised by a function which is applied with stable haemodynamics, said function forming a loop and therefore assigning FiO₂ and PEEP to one another, depending on whether the supply intensity is increased or reduced.

16. A device according to one of the preceding claims, characterised in that the computer is programmed such that a so-called recruitment manoeuvre is carried out before an increase of the PEEP.

17. A device according to one of the claims 12 to 16, characterised in that the diagrammatically representable functions are programmed in a manner configurable by a human operator.

18. A device for the regulation of the settings of a ventilator, with sensors for monitoring the success of the ventilation and the oxygen supply, with a programmable computer for activating the ventilator with the purpose of controlling the ventilation and the oxygen supply on account of the sensor signals, in which computer

- a first ventilation control loop (39) is programmed, in order to set the target frequency (RR^sp) and the inspiration pressure (Pi_nsp) in accordance with the patient, and thus to achieve a target value for the intensity of the ventilation, and a target value for the arterial Cθ₂-partial pressure of the patient which corresponds the present intensity of the ventilation,

- a second ventilation control loop (45) is programmed, in order, should the total respiratory frequency exceed the computed target frequency by a certain value, to reduce the target value for the arterial CO₂- partial pressure and to increase the target value for the ventilation intensity, in a temporally limited manner, - a first supply control loop (17) is programmed, in order to set the oxygen concentration of the ventilation gas (FiO₂) and the end-expiratory pressure (PEEP) and thus to achieve a target value for the oxygen supply of the patient, and

- a second supply control loop (19) is programmed, in order to increase merely the oxygen concentration in the ventilation gas (FiO₂) until a renewed setting OfFiO₂ and PEEP by way of the first supply control loop (17), as soon as a representative reading (SaO₂ ¹^) for the success of the oxygen supply falls below a certain limit value.

19. A ventilator with a device for the regulation of the settings of the ventilator, in particular according to one of the claims 1 to 18, with a sensor for checking the success of the oxygen supply, and with a computer with input possibilities for the haemodynamic stability of the patient, for the input of a patient parameter, as well as a strategic goal, said computer being programmed in order to automatically compute PEEP and FiO₂ on account of sensor values and the input values, and to regulate the settings of the ventilator accordingly.

20. A method for the regulation of PEEP- and FiO₂-settings of a ventilator for achieving an arterial oxygen partial pressure in the blood of a patient mechanically ventilated with the ventilator, with which at least one reading which is representative of the success of the oxygen supply is measured continuously or at intervals, the values of PEEP and FiO₂ are optimised with a first control loop in temporal intervals on account of the reading (SaO₂ ¹^) representative of the success of the oxygen supply and a predefined, necessary supply intensity necessary, and the ventilator is activated accordingly, and therebetween, if necessary, only FiO₂ is increased with a second control loop on account of the current representative reading (SaO₂^).

21. A method according to claim 20, characterised in that the representative reading is a continuously measured reading which is representative of the oxygen saturation of the blood.

22. A method according to one of the preceding claims, characterised in that a necessary supply intensity is computed with a first algorithm of the first control loop on account of the current representative reading (SaO₂^¹") and the current supply intensity, and the individual values for PEEP and FiO₂ are evaluated with a second algorithm of the first control loop on account of the necessary supply intensity.

23. A method according to claim 22, characterised in that a patient parameter which characterises the lung condition is taken into account in the first algorithm.

24. A method according to claim 22 or 23, characterised in that the first algorithm assigns the representative reading and the current supply intensity in each case to one of three regions, said regions being defined by two characteristic lines distanced to one another, which in each case determine for a given supply intensity a minimal and maximal representative value, and between them define a normal region for the representative value (SaO₂ ¹^) .

25. A method according to claim 24, characterised in that the first algorithm is formed on the basis of different characteristic line courses, according to the patient parameter and strategic goal.

26. A method according to one of the claims 22 to 25, characterised in that a haemodynamics input value which characterises the haemodynamic stability of the patient is taken into account in the second algorithm.

27. A method according to one of the claims 22 to 26, characterised in that the second algorithm determines the current values for PEEP and FiO₂ on account of a diagrammatically representable function, said function in each case assigning a value for PEEP to a value for FiO₂.

28. A method according to claim 27, characterised in that the second algorithm uses different functions depending on the current haemodynamics input value, on a reading indicating the haemodynamics of the patient, and on the current patient parameter.

29. A method according to claim 28, characterised in that with instable haemodynamics, the applied function assigns FiO₂ and PEEP to one another independently of whether the supply intensity is increased or reduced.

30. A method according to claim 28, characterised in that with stable haemodynamics, the applied function forms a loop and therefore assigns FiO₂ and PEEP to one another depending on whether the supply intensity is increased or reduced.

31. A method according to one of the preceding claims, characterised in that a recruitment manoeuvre is carried out before a PEEP-increase.

32. A method according to one of the claims 27 to 31, characterised in that at least one diagrammatically representable function is modified and this thus newly configured function forms the basis of the second algorithm.

33. A method for the regulation of the settings of a ventilator, with which method the target frequency (RR^sp) and the inspiration pressure (P_msp) are set with a first ventilation control loop (39), in order to fulfil target values for an arterial CO₂-partial-pressure in the patient blood and for a ventilation intensity, in accordance with the patient, and by way of a second ventilation loop (45), in a temporally limited manner, the target value for the arterial CO₂-partial-pressure is reduced, and the target value for the ventilation intensity is increased, in the case that the total respiratory frequency exceeds the computed target frequency by a certain value, and the oxygen concentration of the respiratory gas (FiO₂) and the end-expiratory pressure (PEEP) are set with a first O₂-supply control loop (17), in order to fulfil target values for the supply intensity and an oxygen concentration in the patient blood, in accordance with the patient, and the oxygen concentration in the respiratory gas (FiO₂) is increased by way of a second O₂-supply control loop (19) until a renewed setting OfFiO₂ and PEEP by way of the first O₂ supply control loop, as soon as a representative reading (SaO₂ ¹^) for the oxygen concentration in the patient blood falls below a certain limit value.

34. A device for regulating settings of a ventilator for achieving an adapted mechanical ventilation of a patient, comprising:

- at least one sensor, preferably at least two sensors, specifically at least one sensor for the continuous measurement or for the measurement in temporal intervals at least of one reading representative of the success of the O₂-supply, and/or at least one sensor for the continuous measurement or measurement in temporal intervals of at least one reading representative of the success of the ventilation,

- a programmed computer,

- which is provided with at least one first electronic control loop functioning in a long-term manner, specifically a control loop in order to optimise PEEP and FiO₂, and/or a control loop in order to optimise P^ and RRMV on account of the representative reading and a predefined necessary ventilation intensity, and said computer being programmed in a manner such that the ventilator in each case is activated according to the current optimisation, and

- which is equipped with at least one second electronic control loop functioning in a short-term manner, specifically a control loop, in order between the optimisations by way of the first control loop, if necessary to increase the FiO₂ on account of the current representative value, and/or a control loop, in order between the optimisations by way of the first control loop, if necessary, to increase the ventilation on account of the current representative value.

35. A device according to claim 34, characterised in that an oxygen sensor for checking the oxygen supply of the patient, in particular of the oxygen saturation in the blood of the patient, and a C0₂-sensor for checking the ventilation, in particular the arterial CO₂-partial-pressure of the patient and all four control loops, are present.