This application claims the benefit of United Kingdoms Patent Application No. 0703259.2, filed on Feb. 20, 2007, under 35 U.S.C. 119. The entire disclosure of the prior application is considered to be part of the disclosure of the instant application and is hereby incorporated by reference therein.
Embodiments of the invention relate to cardiopulmonary resuscitation (CPR) and, more particularly, to method and system aiding decision making during a CPR process.
Presently, the Guidelines for CPR in principle advocate a single-treatment recommendation for all patients, although deviation from the recommended treatment is allowed. For example, a medical director might advocate that some CPR should be carried out before defibrillation for ventricular fibrillation (VF) arrests. As another example, some rescuers might be unwilling to perform mouth to mouth ventilation. While recent studies have demonstrated that one alternative treatment benefits patients of VF arrest, the alternative treatment does not necessarily benefit patients showing non-VF rhythms. For instance, some groups of patients (e.g., asystole patients) might benefit from certain drugs or drug combinations. On the other hand, gasping has been shown to be associated with improved hemodynamics at least for some other patients.
All in all, there is evidence that some patients might benefit from a custom-tailored therapy rather than a one-size-fits-all treatment currently advocated. More specifically, it would be beneficial that the sequence, timing, duration, and/or dose of the available therapy elements, including compressions, ventilations, defibrillation and medication, could be adjusted for each patient and determined on a case-by-case basis.
United States Patent Publication No. 2005/0197672 A1 describes a resuscitation system, which comprises devices for delivering defibrillation shocks, and devices for detecting an electrocardiogram (ECG) signal to determine whether the cardiac rhythm is shockable or not. This determination is based on detected ECG signal during periods where CPR chest compression is not delivered. This is due to the fact that CPR produces artifacts in the ECG signal, which cannot be used to assess the heart's state. A typical detection time sequence for this device comprises a fixed compression time followed by a pause during which the heart state is assessed and defibrillation (if necessary) is performed.
In other devices, a process that alternately delivers defibrillation and CPR according to a fixed pattern is carried out. With such devices, an analysis of the patient's condition is performed after a predetermined time has elapsed, and outcome of the analysis is used to decide how to proceed further. Still, because the analysis is performed after the predetermined time has elapsed, it is not performed continuously throughout the resuscitation of the patient.
There is, therefore, a need for a method and system for decision-making support during cardiac arrest resuscitation to continuously provide recommendation regarding actions to be taken in order to minimize required pauses in the treatment.
Certain details are set forth below to provide a sufficient understanding of embodiments of the invention. However, it will be clear to one skilled in the art that embodiments of the invention may be practiced without these particular details. Moreover, the particular embodiments of the present invention described herein are provided by way of example and should not be used to limit the scope of the invention to these particular embodiments.
Sensors (not shown) for receiving the input signals 1 may include sensors for compression, ventilation, impedance, electrocardiogram (ECG), end-tidal carbon dioxide (ETCO2) and pressure, as well as indicators/detectors for a secure airway. Decision support, in terms of recommendations, is provided in the form of output signals 3. These output signals 3 include recommendations on, for example, compressions, ventilations, defibrillation, drugs, and characteristics of the process, etc. Possible receivers of the output signals 3 include, for example, AEDs (automatic external defibrillators), ALS-monitors/defibrillators, mechanical chest compression machines, ventilation/respiration monitors, or various combinations of such devices. A rescuer will in general receive decision support from one of the aforementioned devices in some embodiments, but it is also possible for the system to provide decision support directly to the rescuer in other embodiments of the invention. The output signals 3 may also be used to automatically control actions in a receiving device or to provide information allowing the user to make the decision with respect to next-step actions. In one embodiment, the processor 2 may be a processor of a device that utilizes the output signals 3. In another embodiment, the processor 2 may be part of a stand-alone device that provides the output signals 3 to other devices that utilize the output signals.
A method according to the system just described may comprise the step of receiving by a input unit the input signals 1 related to the resuscitation process, such as, for example, compressions (e.g., parameterized information or signals correlated with compressions, such as depth, force, and acceleration), ventilations, ECG, impedance, ETCO2, SpO2, pressure, and secure airway indication. Some of the aforementioned signals may be related to the patient's bodily functions (e.g., ECG, impedance, ETCO2, SpO2, pressure) while others may be related to the resuscitation process (e.g., compressions, ventilations, secure airway indication). The input unit may be connected to a resuscitation machine and it can also receive inputs directly from sensors on the patient.
The method also includes the step of processing the input signals 1 by the processor 2 to provide a representation of the resuscitation process based on the input signals 1 and predetermined criteria. The representation is used to generate output signals 3 representative of actions to be taken during resuscitation and/or characteristics of the process (e.g., VF vitality). The predetermined criteria may be, for example, those criteria established in the International Guidelines for CPR. Of course, the predetermined criteria need not be limited to the context of the International Guidelines for CPR and may comprise other predetermined criteria, as will be appreciated by those ordinarily skilled in the art. Processing of the input signals 1 by the processor 2 may comprise filtering of ECG signals and analysis of parameters of the filtered signals to check for onset of a shockable rhythm. The method further includes the step of delivering the output signals 3. As mentioned above, output signals 3 may be delivered to resuscitation machines, defibrillator or other type of client devices, or to one or more rescue personnel.
In one embodiment of the invention, the process performed by the processor 2 includes filtering of ECG signals to remove CPR noise. This step allows the possibility of monitoring ECG during most of the resuscitation process. It is thus no longer necessary to interrupt the CPR in order to obtain ECG signals to decide whether defibrillation is necessary or not. Accordingly, ECG signals can be monitored continuously and CPR will only be interrupted when defibrillation is actually taking place. If the filtered ECG signal does not denote that defibrillation is necessary, the CPR process may continue uninterrupted. In an embodiment, a system may also include an evaluation algorithm to detect when filtering is sufficient (that is, when the results of the filtering can be trusted), including periods of time when compressions are being performed.
According to an embodiment of the invention, ECG signals are processed to detect the onset of a shockable rhythm indicative of ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT). In the rest of the specification, VF, VT and the term shockable rhythm are used interchangeably. Ventricular fibrillation typically deteriorates over time and the CPR provided may not be sufficient to stop or reverse it. In general, the probability of ROSC (Restoration of Spontaneous Circulation) shock seems to be highest near onset of ventricular fibrillation (e.g., within <30 seconds). Therefore, it is important to have the ability to detect a strong ventricular fibrillation at its onset. AEDs typically have an algorithm for distinguishing a shockable rhythm from a non-shockable rhythm. However, the algorithm might be computationally heavy, seldom run continuously, and not giving reliable results in the presence of compressions. The aim of this embodiment of the invention is to provide a method for detecting ventricular fibrillation onset continuously, and during chest compressions, by using artifact filtering.
Detection of a shockable rhythm will, in one embodiment, trigger monitoring of VF vitality (reflecting the state of the myocardium) and trending of VF vitality to assess whether defibrillation shock or CPR should be recommended. VF vitality in the context of the present application refers to a value or values derived from the ECG signals. These values may be, for example, the mean or median slope of the ECG signals. Other values may be median frequency, amplitude, etc. Slope deviation can be used to assess vitality/quality of a non-shockable rhythm. Accordingly, one method for detection of ventricular fibrillation onset according to the invention comprises calculation of mean slope, median slope, slope deviation and rate for CPR-filtered ECG signals. It is also possible to calculate such parameters for non-filtered signals, especially in the case where CPR is not being performed.
As mentioned before, prior art devices are able to detect the presence of ventricular fibrillation at a determined point in time. They are, however, not made to detect onset of ventricular fibrillation and will work poorly during ongoing chest compressions. In contrast, continuous detection combined with appropriate processing of determined characteristics of the ECG signals and their variation, according to an embodiment of the invention, will provide an indication of VF onset.
As shown in
In the embodiment illustrated in
1) Very high amplitude in the ECG signal prior to the artifact filtering (e.g., >1.5 mV). The algorithm used by the processor 2 may have a threshold on the number of high amplitude peaks present and/or on portion of high amplitude samples in a segment—correlated and/or non-correlated to the chest compressions. The amplitude threshold might differ depending on whether the high amplitude peaks are correlated with the chest compressions or not.
2) Very high compression rates (e.g., >150 per minute). High compression rates might cause artifacts resembling a shockable rhythm and might be problematic if artifact filtering only removes part of the artefacts.
3) Chest compression rate similar to the intrinsic rate of an organized rhythm (e.g., Pulseless Electrical Activity, or PEA). Artifact filtering may in this case remove too much of the underlying heart rhythm and thus should not be used, or alternatively it should be adjusted to accommodate this situation.
4) Shape (e.g., sharpness/spikiness of compression peak) of the probable ECG compression artifacts differs substantially from the shape of the compressions as presented in the reference channels 11. That is, there might be situations where it is likely that the reference channels 11 do not contain enough information about the artifacts in the ECG signals (e.g., due to nonlinearities).
If the artifact filtering is not considered satisfactory by filter result evaluation in step 13 (e.g., insufficient filtering), the process proceeds to output a signal 14 indicating that decision support cannot be given at the present moment. If, however, the artifact filtering is considered satisfactory (e.g., sufficient filtering), the process continues in steps 15 and 16 where VF/VT onset detection and standard rhythm classification (e.g., shockable versus non-shockable rhythms), respectively, are performed. It should be noted that step 16 may be optional and not necessary to practice embodiments of the invention. In other words, certain embodiments of the invention may detect only VF/VT onset but not perform standard rhythm classification. For each iteration/sample, the input provided for processing in step 15 may be a segment of artefact-filtered ECG waveform (e.g., in segments of 10-second length). In step 15, changes in features of the ECG waveform are calculated and monitored for sub-segments of each of the segments.
The ECG features used in this embodiment of the invention for detecting VF onset include: mean slope (first derivative) of the ECG waveform, median slope (first derivative) of the ECG waveform, slope deviation (relative difference between mean and median slope, as expressed by the equation [mean slope−median slope]/median slope), rate (as expressed by the equation waveform frequency/rate, and may be QRS complex rate where QRS is an electrocardiographic complex consisting of the Q, R, and S waves that represent propagation of a wave of depolarization over the ventricles and commonly measured in beats per minute, or bpm). These features will be defined below:
Mean slope is the mean of the absolute values of the first derivative of the ECG waveform in a segment, e.g. calculated as
where x(n) is an ECG sample in a segment of length L, and fs is the sampling rate.
Median slope is the median of the absolute values of the first derivative of the ECG waveform in a segment, e.g. calculated as
where x(n) is an ECG sample in a segment of length L, and fs is the sampling rate.
Slope deviation is the relative difference between mean and median slope, defined as
The ECG waveform rate is the most “dominant” frequency of the ECG rhythm, such as rate of QRS complexes or beats in an organized rhythm or frequency of dominant VF waveform. The rate can be calculated in many ways For example, it may be calculated using autocorrelation, counting zero crossings or local maxima/minima (spikes), etc.
VF onset detection in step 15 is based on the fact that the ECG feature slope deviation typically has a high value during a non-shockable rhythm while it is typically low for shockable rhythms. To report the onset of a strong VF, the algorithm checks and requires at least one of the following conditions to be true (using typical threshold values):
1) Clear transition to VF: Median slope is larger than 4 mV/s in last two sub-segments (4 & 5) (only strong VFs are to be detected), slope deviation in last two sub-segments (4 & 5) are below a threshold value of 0.5, slope deviation in at least two of the first three sub-segments (1-3) is above a threshold value 0.5, maximum slope deviation value in sub-segments 1-3 is above (or equal to) a higher threshold, e.g., 0.75, and rate of sub-segments 4 and 5 are all above 190 bpm with one of them also above 200 bpm.
2) More subtle transition to VF: Median slope is larger than 4 mV/s in last two sub-segments (4 & 5) (only strong VFs are to be detected), slope deviation in last two sub-segments (4 & 5) are below a threshold value of 0.5, slope deviation in at least two of the first three sub-segments (1-3) are above a threshold value 0.5, maximum slope deviation value in sub-segments 1-3 is below a higher threshold, e.g. 0.75, rate of sub-segments 4 and 5 are all above 190 bpm with one of them also above 200 bpm, rate of sub-segments 1-3 are all below 190 bpm, and the average rate of sub-segments 1-3 is 30 bpm below the average rate of sub-segments 4-5.
Transition to VF from asystole: Median slope is larger than 4 mV/s in last two sub-segments (4 & 5) (only strong VFs are to be detected), slope deviation in last two sub-segments (4 & 5) are below a threshold value of 0.5, maximum median slope value in sub-segments 1-2 is below 0.5 mV/s (indicating asystole), median slope value in sub-segment 3 is below 1 mV/s, and rate of sub-segments 4 and 5 are all above 190 bpm with one of them also above 200 bpm.
Other criteria for VF onset which differ from the aforementioned rules can be used in other embodiments of the invention. Upon detection of a strong VF onset in any of the above-mentioned alternatives in step 15, the process proceeds to step 17. In step 16, a rhythm classifier detects whether or not there is VF, for example, in a standard fashion as known in the art. If VF is detected the process proceeds to step 17.
If VF is present at the start of treatment (initial VF) or after later detection of VF when the patient was not immediately shocked, the process will proceed to step 17, where the vitality of the VF is analyzed and trended by a VF/VT decision support algorithm. In one embodiment of the invention, median or mean slope is used as a measure of VF vitality, where the VF vitality is sampled at fixed time intervals. The trend of VF vitality samples may be estimated using linear regression estimation in a least-squares sense, for example. The trending process may use several samples (e.g., samples from 30 or 60 seconds of time) to report significant positive or negative trends. Vitality and trend values are compared to thresholds and evaluated further to provide recommendations. An example of the tests that are used to control this process may be as follows: 1) If non-shockable rhythm or a time less than 15 seconds has past since start of the trend analysis, recommend CPR; 2) recommend shock after 5 seconds with flat and/or negative trend after a previous positive trend for a period of at least 5 seconds; 3) recommend shock after 180 seconds with flat trend where there is no previous positive trend of a period of at least 5 seconds; 4) recommend shock after 5 seconds with negative trend; or 5) otherwise, recommend CPR. These tests may include those predetermined criteria established by CPR guidelines, as known in the art, and may also include customized rules.
After the VF/VT decision support algorithm applies the aforementioned tests, the process proceeds to provide output signals via output channel 18 for recommendation. These output signals may be provided to one or more output units, such as the output unit 3 of
In case that the process of
In step 21 of the process, the necessity of ventilation is evaluated by an initial ventilation advice algorithm. Before a secured airway is provided (e.g., by means of an endotracheal tube), chest compressions must be interrupted for each ventilation. However, this typically interrupts the blood flow generated by the chest compressions and is thus detrimental to the patient. Studies have shown that, at least for certain group of patients, it may be beneficial to omit ventilations and perform compressions only. One situation where this procedure may be applicable is during witnessed VF arrest. Based on this criterion, the decision support system will in step 21 decide if ventilations are necessary using the following rules (criteria): If it is an initial VF, then postpone start of ventilations until VF is terminated or after a given time (e.g., 5 minutes); but for other initial rhythms, perform ventilations according to current guidelines. Based on the available sensor information, other rules may also be applied. For example, other rules may include the following: 1) If present rhythm is VF, withhold ventilations until VF is terminated or after a given time (e.g., 5 minutes); 2) if present rhythm is PEA, deliver ventilations as per current guidelines; 3) if present rhythm is asystole, deliver ventilations as per current guidelines and also give a drug suitable for asystole patients; or 4) if spontaneous gasping (step 23) is present, withhold ventilations—otherwise deliver ventilations as per current guidelines. The algorithm in step 21 will output a signal 22 recommending compressions only or standard (i.e. compressions and ventilations) CPR. This part of the process may be omitted in alternative embodiments of the invention.
As those ordinarily skilled in the art will appreciate, embodiments of the invention provide the possibility of monitoring and analyzing a resuscitation process while it is being performed. From the foregoing it will be appreciated that, although specific embodiments of the invention have been described herein for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention. Accordingly, the invention is not limited except as by the appended claims.
Number | Date | Country | Kind |
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0703259.2 | Feb 2007 | GB | national |