PROVIDING A PARAMETER WHICH INDICATES A LOSS OF CONSCIOUSNESS OF A PATIENT UNDER ANESTHESIA

Abstract

The invention relates to a method and a device for providing a parameter which indicates a loss of consciousness of a patient under anesthesia. The method has the steps of: detecting (301) at least one EEG signal on the head of the patient; continuously determining (302) the spectral cut-off frequency in a current timeframe of the EEG signal; determining (303) the curve of the spectral cut-off frequency of the EEG signal in a period of time which begins before an anesthesia-inducing medication is administered and ends after the anesthesia-induced loss of consciousness is initiated; determining (304) the absolute minimum of the spectral cut-off frequency in the period of time, wherein a negative peak of the spectral cut-off frequency lies in the absolute minimum, and providing (305) information regarding at which point in time the absolute minimum was reached as a parameter for an indicative notification of the loss of consciousness of the patient.

Claims

1. A method for providing a parameter, which indicates a loss of consciousness in a patient under anesthetic, wherein the method comprises the steps of: recording at least one EEG signal on the patient's head, continuously determining the spectral cutoff frequency in a current timeframe of the EEG signal, wherein the spectral cutoff frequency indicates the frequency at which 95% of the overall power is included in the power spectrum, determining the response of the spectral cutoff frequency of the EEG signal in a period of time that begins before an anesthesia-inducing medicine is administered and after the occurrence of the anesthesia-induced loss of consciousness ends, determining the absolute minimum of the spectral cutoff frequency in the period of time, wherein a negative peak in the spectral cutoff frequency is present in the absolute minimum, and providing information relating to the point in time at which the absolute minimum has been reached as a parameter for the indicative indication of a loss of consciousness in the patient.

2. The method as per claim 1, characterized in that at least one frontal EEG signal is picked up.

3. The method as per claim 2, characterized in that a plurality of frontal EEG signals are picked up, which are averaged before the spectral cutoff frequency is determined.

4. The method as per claim 3, characterized in that, in the 10-20 system, signals are deducted by electrodes that are positioned in positions F7, F8, Fp1, Fp2 and Fpz.

5. The method as per claim 1, characterized in that the spectral cutoff frequency is continuously determined by being re-determined at least every 30 seconds.

6. The method as per claim 1, characterized in that the information relating to the point in time at which the absolute minimum has been reached is provided as soon as said minimum has been determined.

7. The method as per claim 6, characterized in that the information relating to the point in time at which the minimum has been reached is provided if the spectral cutoff frequency has fallen below a value of 10 hertz and re-increases.

8. The method as per claim 6, characterized in that the information relating to the point in time at which the minimum has been reached is provided if, for a defined number of measured values, the measured value for the spectral cutoff frequency is greater than the previous measured value.

9. The method as per claim 1, characterized in that the spectral cutoff frequency of the EEG signal is determined after this signal has been filtered through a bandpass filter.

10. The method as per claim 1, characterized in that the spectral cutoff frequency is ascertained by means of a spectral analysis, a concurrent timeframe of the EEG signal being evaluated in each case.

11. A computer program comprising a program code for carrying out the method according to claim 1 when the computer program is executed on a computer.

12. A device for providing a parameter, which indicates a loss of consciousness in a patient under anesthetic, in particular for carrying out the method according to claim 1, wherein the device comprises: means, which are designed to record at least one EEG signal on the patient's head, means, which are designed to continuously determine the spectral cutoff frequency in a current timeframe of the EEG signal, wherein the spectral cutoff frequency indicates the frequency at which 95% of the overall power is included in the power spectrum, means, which are designed to determine the response of the spectral cutoff frequency of the EEG signal in a period of time that begins before an anesthesia-inducing medicine is administered and finishes after the occurrence of the anesthesia-inducted loss of consciousness, means, which are designed to determine the absolute minimum of the spectral cutoff frequency in the period of time, wherein a negative peak of the spectral cutoff frequency is present in the absolute minimum, and means, which are designed to provide information relating to the point in time at which the absolute minimum has been reached as a parameter for the indicative indication of a loss of consciousness in the patient.

13. The device as per claim 12, characterized in that the means that are designed to continuously determine the spectral cutoff frequency in a current timeframe of the EEG signal are designed to re-determine the spectral cutoff frequency at least every 30 seconds.

14. The device as per claim 12, characterized in that the means that are designed to provide information relating to the point in time at which the absolute minimum has been reached are designed to provide the information as soon as the absolute minimum has been determined.

15. The device as per claim 14, characterized in that the means that are designed to provide information relating to the point in time at which the absolute minimum has been reached are designed to provide the information if the spectral cutoff frequency has fallen below a value of 10 hertz, and re-increased.

16. The device as per claim 14, characterized in that the means that are designed to provide information relating to the point in time at which the absolute minimum has been reached are designed to provide the information if, for a defined number of measured values, the measured value for the spectral cutoff frequency is greater than the previous measured value.

17. The device as per claim 12, characterized in that the means that are designed to continuously determine the spectral cutoff frequency comprise means that are designed to carry out a spectral analysis, a concurrent timeframe of the EEG signal being evaluated in each case.

18. The device as per claim 12, characterized in that the means that are designed to continuously determine the spectral cutoff frequency are designed to determine the spectral cutoff frequency of the EEG signal after this signal has been filtered through a bandpass filter.

19. The device as per claim 12, characterized in that the means that are designed to record at least one EEG signal on the patient's head are designed to pick up at least one frontal EEG signal.

20. The device as per claim 19, characterized in that the means that are designed to record at least one EEG signal on the patient's head are designed to receive a plurality of frontal EEG signals that are averaged before the spectral cutoff frequency is determined.

21. An EEG anesthesia monitor comprising a device according to claim 12.

Description

[0030] The invention will be explained in more detail in the following with reference to the figures in the drawings and on the basis of several embodiments, in which:

[0031] FIG. 1 shows, by way of example, EEG signals in the awake state and after an anesthesia-induced loss of consciousness both as a time-dependent signal and in the power spectrum;

[0032] FIG. 2 shows, by way of example, the temporal course of the spectral cutoff frequency in a period of time that begins before the occurrence of an anesthesia-induced loss of consciousness in a patient and ends after the occurrence of the anesthesia-induced loss of consciousness;

[0033] FIG. 3 is a flow diagram of the method according to the invention;

[0034] FIG. 4 shows, by way of example, a device for carrying out he method in FIG. 3; and

[0035] FIG. 5 shows positioning points for EEG electrodes according to the 10-20 system.

[0036] The relationship that is identified first according to the present invention between the time course of the spectral cutoff frequency and the occurrence of the loss of consciousness when anesthetic has been administered will firstly be explained on the basis of FIGS. 1 and 2, which relationship has been proven by means of a study.

[0037] In order to explain the background of the invention, FIG. 1 shows in the upper illustration (“output signal”) an EEG signal as occurs in a patient that is awake. The signal is depicted both as a time signal (left) and as a power spectrum (right) following a spectral analysis. In the power spectrum, the power (the square amplitude) is plotted in db against the frequency in Hz. The power spectrum displays the relevant proportion of the overall power proportion of the raw signal that the individual frequency ranges make up. The spectral cutoff frequency SEF is likewise shown. This is defined as the frequency below which a proportion of 95% of the energy of the overall spectrum lies. The median frequency F50 is also depicted, but this does not matter in the present case.

[0038] The bottom representation (“anesthesia”) in FIG. 1 shows an EEG signal under anesthesia. It is evident that the spectral cutoff frequency SEF is shifted to the left with respect to the value in a patient that is awake.

[0039] The spectral cutoff frequency (SEF) therefore provides information regarding how awake a patient is. Since in the awake state the EEG signal contains higher frequencies, high values occur for the spectral cutoff frequency. In the asleep state or under anesthesia, slow frequencies dominate in the EEG such that lower values occur for the spectral cutoff frequency.

[0040] The processes during the introduction of an anesthetic are now observed. When introducing an anesthetic, the patient is initially awake. High SEF values of approximately 17-20 Hz occur. The patient passes into a deep loss of consciousness under anesthesia. Purdon P L, Pierce E T, Mukamel E A, Prerau M J, Walsh J L, Wong K F K, Salazar-Gomez A F, Harrell P G, Sampson A L, Cinemser A, Ching S, Kopell N J, Tavares-SToeckel C, Habeeb K, Merhar R, Brown E,: “Electroencephalogram signatures of loss and recovery of consciousness from propofol,” PNAS 2013; 110 (12): E1142-1151 have shown that a deep loss of consciousness induced by GABA-activating anesthetics leads to a frontal alpha-band activation. As a result, relatively higher SEF values of 12-17 Hz are also shown during surgery amid a deep loss of consciousness.

[0041] In the present case, a prospective observational study was able to show that there is a very brief drop in the SEF value at precisely the point of the anesthetic-induced loss of consciousness, which is associated with a subsequent re-increase. The minimum of the resultant negative peak here indicates the point in time of the anesthesia-induced loss of consciousness.

[0042] The study was carried out on a group of a total of 37 older patients, in which the anesthetic was introduced with one of the most frequently used anesthetics, specifically Propofol. It may be assumed that, in younger adults, there is an even more significant drop in the spectral cutoff frequency at the point of the anesthetic-induced loss of consciousness.

[0043] The measurements were carried out as follows. [0044] a) EEG deduction;

[0045] In the perioperative EEG determination, the EEG electrodes were affixed to the patient while they were still awake before the first medication was administered by the anesthetist. For this purpose, the forehead and the temples were thoroughly disinfected and freed of skin oils. This measure improved the conductivity of the skin and therefore guaranteed an interference-free deduction of the EEG signals. The ready-made EEG self-adhesive electrodes by Masimo (4248RD SEDLine Sensor, Single Patient Use, Non-Sterile) were then affixed to the forehead on the prepared skin areas, in which the EEG electrodes each rest on the positions F7, F8, FP1 and FP2 according to the 10/20 system, with Pfz as the reference electrode. The corresponding positions are shown in FIG. 5. The impedance of the individual electrodes was below 5 kΩ and the sampling rate was 250 Hz during the deduction. A bandpass filter was preset to 0.5-40 Hz.

[0046] After connecting the self-adhesive electrodes to an EEG-based brain function monitor (the “SEDLine Monitor” by Masimo Corporation, Irvine, Calif.), the deduction and recording of a continuous 4-channel EEG was begun. The patients were still awake at this point, and therefore the first values of the deduction corresponded to a baseline activity. In order to determine specific points in time during the EEG deduction, “Event Markers” were manually entered in the EEG during the EEG recording. The administration of the medicine was initiated by the anesthetist in the process. This point in time was noted as the event marker “Start Anesthesia.” All patients were given the medication Propofol intravenously in order to initiate the anesthesia. The state of consciousness of the patient was continuously checked by means of the eyelid reflex, in the event of no eyelid reflex a loss of consciousness was assumed and the event marker “loss of consciousness” was set. This procedure allows for the data to be evaluated exactly to the second. [0047] b) EEG evaluation

[0048] The following data were recorded by the SEDLine monitor; the spectral cutoff frequency (SEF), the anesthesia index (PSI), the artifact level and the electromyographic activity. These EEG data were manually exported from the SEDLine monitor and displayed in numerical format on the computer in Excel tables.

[0049] By means of the recording rate of the SEDLine of 30 values per minute, all measured values were provided every two seconds. For each patient, a check was first made to see whether the “baseline,” “start anesthesia” and “loss of consciousness” points in time tested had been fully drawn and were free from artifacts. For this purpose, both the artifact level calculated by the instrument and the EMG artifacts likewise drawn were inspected. Usable data records were divided into timeframes of 20 seconds each for “loss of consciousness.” During each timeframe that stretched from 200 seconds before “loss of consciousness” to 200 seconds after “loss of consciousness,” the artifact-free spectral cutoff frequency of each patient was averaged for the right and left cerebral hemisphere.

[0050] The power spectrum for determining the spectral cutoff frequency was therefore determined in EEG signal timeframes of 20 seconds, in which an update was made every 2 seconds. The calculation was carried out by means of digital computer-assisted EEG signal processing. The basis for this is the spectral analysis of the raw EEG by means of Fast Fourier Transformation, by means of which the power proportions for each timeframe currently to be analyzed can be calculated.

[0051] In order to firstly ascertain whether there is a difference between the examination of the right and left hemisphere, the values before the medication was administered (−200 seconds), at the point in time of the loss of consciousness (0 seconds) and after the introduction (+200 seconds) in all patients having a dominant right hand (n=36) were used to carry out a 2-sided t-test for dependent samples. Since at none of the points in time was there a significant difference (before the medication was administered p=0.26, during a loss of consciousness p=0.940, after introduction p=0.44), the relevant average value was worked with for the right and left cerebral hemisphere in the further course.

[0052] All variables were tested for their normal distribution. For this purpose, the histogram and the Q-Q plot were each visually inspected and the data were analyzed by means of the Lilliefors Tests, the Shapiro-Wilk test and the values were analyzed for skewness and kurtosis,

[0053] In order to depict the introduction, operation and removal, the times indicated for the event markers of the EEG deduction were evaluated and tested for average values and standard deviations by means of descriptive statistics.

[0054] The response of the spectral cutoff frequency was examined in order to determine the occurrence of the anesthesia-induced loss of consciousness in the context of a single-factor one-way ANOVA (“analysis of variance”) and the associated post-hoc test.

[0055] In order to examine the spectral cutoff frequency in the period of time from 200 seconds before the occurrence of the anesthesia-induced loss of consciousness up to 200 seconds after the occurrence of the anesthesia-induced loss of consciousness for a possible influence of the point in time of the intubation, the start of the intubation was correlated with the points in time from 20 seconds after “loss of consciousness” up to 200 seconds after “loss of consciousness” using the correlation according to Pearson. In order to demonstrate the response without the possible influence of the intubation, the study population was divided into two groups. Patients in which intubation was begun within 200 seconds after “loss of consciousness” represented one group, patients in which intubation was begun after more than 200 seconds represented the other group. These were then examined for equality of variances using the Levene test and then tested for significant differences between groups using a t-test for independent samples. By only presenting those cases in which the intubation was only carried out after the period of time under consideration, the intubation could therefore be eliminated as a possible interference factor.

[0056] FIG. 2 shows the average values determined during the study for the spectral cutoff frequency (SEK) as a function of time. In this case, the average value for the spectral cutoff frequency is given in Hz over the point in time of the loss of consciousness during the period of time from 200 seconds before the loss of consciousness up to 280 seconds after the loss of consciousness. The loss of consciousness (LOC) is denoted as “00” on the time axis here.

[0057] The following table indicates the numerical values for the diagram in FIG. 2 including the particular standard deviation:

TABLE-US-00001 Point in time in Average seconds value in Standard before/after LOC Hz deviation −200 16.1522 6.63732 −180 13.4322 5.82472 −160 14.2643 6.29292 −140 13.4243 6.27143 −120 14.3168 6.59561 −100 12.5081 6.12921 −80 13.0448 5.61589 −60 13.8354 5.55857 −40 12.6829 5.85254 −20 10.1051 4.09247 00 7.9307 3.96740 20 9.0013 3.71247 40 9.6232 3.08994 60 10.9800 2.94291 80 10.6930 3.24560 100 12.0464 2.41244 120 12.4408 2.80897 140 12.5120 3.03307 160 12.0910 2.51989 180 12.1213 3.70452 200 11.8718 3.60563 220 12.0961 3.69842 240 12.8673 3.18760 260 12.8035 3.35782 280 12.4916 3.15537 Overall 11.8354 4.38536

[0058] A clear negative peak can be seen, which has its minimum at the point in time of the loss of consciousness (point in time “00”). The spectral frequency average drops from values of approximately 12-14 Hz to approximately 8 Hz in this case and then increases to approximately 12-13 Hz. The width of the negative peak is approximately 2 minutes. By determining the minimum of the negative peak, the occurrence of the loss of consciousness can be determined with an accuracy of 20 seconds or even less.

[0059] According to the invention, the correlations determined are evaluated electronically or using a computer and are used to determine the response of the spectral cutoff frequency of the EEG signal and to determine the absolute minimum of the spectral cutoff frequency in said response as a parameter for the occurrence of the anesthesia-induced loss of consciousness. The associated program can be integrated in an EEG-based brain function monitor or electroencephalograph as a software tool in this case.

[0060] FIG. 3 shows the method for determining a parameter, which indicates a loss of consciousness in a patient under anesthesia. According to step 301, at least one frontal EEG signal is recorded on a patient. For example, four EEG signals are picked up by means of electrodes in the positions F7, F8, FP1 and FP2 according to the 10/20 system, with Fpz as the reference electrode and an average of these signals is given.

[0061] According to step 302, the spectral cutoff frequency is continuously determined within a current timeframe of the EEG signal. The determination is carried out continuously, for example in that an up-to-date determination of the spectral frequency is made every 2 seconds or every 5 seconds. The current timeframe has a length of 20 seconds, for example, in which said values are only to be understood by way of example.

[0062] In step 303, the response of the spectral cutoff frequency of the EEG signal is evaluated. This is carried out in a period of time that begins before an anesthesia-inducing medication (for example Propofol) is administered and after the occurrence of the anesthesia-induced loss of consciousness ends. In this case, the period of time can or cannot be established with regard to its duration. In the second instance, the period of time ends as soon as the minimum could be determined for the spectral cutoff frequency, for example.

[0063] In step 304, the absolute minimum is determined for the spectral cutoff frequency in the period of time under consideration. For example, this can be carried out by evaluating whether or not the spectral cutoff frequency has fallen below a value of 10 hertz, in particular below a value of 9 Hertz, and re-increases. Alternatively or in addition, it is also possible to evaluate whether, for a defined number of measured values, the measured value for the spectral cutoff frequency is greater than the previous measured value. A negative peak in the spectral cutoff frequency is therefore evaluated, in which the absolute minimum of the spectral cutoff frequency lies in the negative tip of the negative peak. Additional data analysis and curve sketching methods can be used to determine the absolute minimum of the spectral cutoff frequency with the greatest possible degree of accuracy.

[0064] As soon as the absolute minimum has been determined for the spectral frequency, this information is provided, for example acoustically and/or on the display of an EEG monitor, as a parameter in order to indicatively indicate a loss of consciousness in the patient.

[0065] According to step 306, a doctor or an anesthetist can use this information to accurately adapt an intubation to be carried out to the patient's individual state of conscious so as not to carry out the intubation too early or too late. This leads to a greater degree of safety for patients when introducing the anesthetic.

[0066] In order to carry out the method, an EEG-based brain function monitor or a computer in general can be used. The method steps for determining and evaluating the spectral cutoff frequency and for determining the absolute minimum of the spectral cutoff frequency are carried out by a program code here, which is executed in a processor. The program code is stored in a memory of the processor or is loaded therein before being executed. The processor that executes the program code can be the main processor of the EEG monitor or a separate processor.

[0067] FIG. 4 shows, by way of example, a possible way of implementing such an EEG-based brain function monitor 1. The EEG monitor 1 comprises a microprocessor 2, a memory 3, a control apparatus 4, an output unit 5 and an interface 7 for connecting EEG cables.

[0068] By means of the interface 7, EEG cables comprising EEG electrodes 61, 62 can be connected to the EEG monitor 1. Two EEG cables that pick up an EEG signal are depicted by way of example, whereby additional EEG cables can be provided in order to pick up a multichannel EEG signal.

[0069] The EEG signal is supplied to the microprocessor 2. The program code is stored in the memory 3 or a program code can be loaded in the memory 3, which, when executed in the microprocessor 2, carries out the method explained with reference to FIG. 3. The process can be controlled by means of the control apparatus 4, and this can be designed to obtain corresponding input commands. The control apparatus 4 can be a main processor of the EEG monitor 1 or can contain such a processor in this case. Alternatively, the functionality of the microprocessor 2 can be taken over by the control unit 4. By means of the control unit 4 and/or additional modules (not shown), additional functionalities of the EEG monitor 1 can be implemented.

[0070] When carrying out the loaded program code, the microprocessor 2 therefore determines the absolute minimum of the spectral cutoff frequency and the point in time at which this absolute minimum is present. The corresponding information is transmitted to the output unit 5 and output thereto. This can be done by means of a monitor 51 and/or an acoustic unit 52, for example.

[0071] Of course, the invention is not restricted to the above-described embodiments and various modifications and improvements can be made without deviating from the concepts described here. Any of the features can be used separately or in combination with any other features provided that they are not mutually exclusive, and the disclosure extends to, and comprises, all combinations and sub-combinations of one or more features described here. Wherever ranges are defined, these therefore include all the values within these ranges and all sub-ranges that fall within a range.