The following relates generally to the capnography arts, medical monitoring arts, and related arts.
A capnography device monitors the concentration or partial pressure of carbon dioxide (CO2) in respiratory gases. Capnography is commonly used in conjunction with mechanically ventilated patients in order to assess respiratory system status. A skilled anesthesiologist can evaluate the capnogram (that is, the CO2 trend line as measured by a capnograph device) to assess respiratory health.
Capnography is increasingly used as a more generic vital sign for assessing patient health. For example, capnography may be used to monitor a patient who is breathing spontaneously and not undergoing mechanical ventilation, using a side stream capnograph device configuration in which respired air is sampled via a nasal cannula in conjunction with a dedicated sampling pump. In these broader contexts, medical personnel with limited expertise in anesthesiology are required to assess respiratory health on the basis of capnograph data. To facilitate this, it is common for the capnograph device to be programmed to output standard derived parameters, particularly respiration rate (RR) and end-tidal CO2 (etCO2). The RR is the breathing rate, quantified as the (quasi-)periodicity of the capnogram waveform. The etCO2 is the partial pressure at the end of the exhalation phase. However, since the expired CO2 is usually highest at the end of the exhalation phase, etCO2 is commonly defined as the maximum observed CO2 partial pressure over the breathing cycle.
While RR and etCO2 are useful parameters, they do not capture the rich informational content of the capnogram waveform. To this end, it is also known to perform automated capnogram waveform analyses, designed to mimic clinical analyses that might be performed by a skilled anesthesiologist. For example, Colman et al., U.S. Pat. No. 8,412,655 and Colman et al., U.S. Pat. No. 8,414,488 disclose capnogram waveform analyses such as correlating pauses with apnea events, correlating a long downward slope of the capnogram waveform with possible partial airway obstruction, correlating a low capnogram waveform with possible low blood pressure, correlating a rounded capnogram waveform with a possible problem with the nasal cannula, or so forth. Based on such waveform analyses, the capnograph device may provide informational messages such as “open airway”, “check airway”, “check blood pressure”, “check cannula interface”, or so forth.
Capnogram waveform analyses provide richer information from the capnogram, but entail complex processing such as detecting the breath cycling, amplitude and period normalization, and segmenting regions of the capnogram waveform within each breath cycle. These complex analyses introduce numerous possible error mechanisms such as incorrect waveform segmentation or information loss during the normalization operations.
The following discloses a new and improved systems and methods that address the above referenced issues, and others.
In one disclosed aspect, a capnograph device comprises a carbon dioxide measurement component configured to measure respiratory carbon dioxide level, and an electronic processor programmed to: generate a capnogram signal comprising carbon dioxide level sample values measured by the carbon dioxide measurement component as a function of time; determine an end-tidal carbon dioxide (etCO2) value from the capnogram signal; and compute an end-tidal carbon dioxide parameter quality index (etCO2 PQI) value based on a waveform of the capnogram signal. A display component may be provided to display the etCO2 value and the etCO2 PQI value. In some embodiments the electronic processor computes the etCO2 PQI by operations including generating a capnogram histogram by binning counts of carbon dioxide level sample values of the capnogram signal into carbon dioxide level bins.
In another disclosed aspect, a capnograph device comprises a carbon dioxide measurement component configured to measure respiratory carbon dioxide level, and an electronic processor programmed to: generate a capnogram signal comprising carbon dioxide level sample values measured by the carbon dioxide measurement component as a function of time; compute a quantitative capnogram waveform metric from the capnogram signal; determine an end-tidal carbon dioxide (etCO2) value and a respiration rate (RR) value from the capnogram signal; compute an end-tidal carbon dioxide parameter quality index (etCO2 PQI) value using the quantitative capnogram waveform metric; and compute a respiration rate parameter quality index (RR PQI) value using the RR value and the etCO2 PQI.
One advantage resides in providing a capnograph device whose output more effectively assesses patient respiratory health.
Another advantage resides in providing a capnograph device outputting derived parameters characterizing the detailed capnogram waveform without requiring breath detection or segmentation of the capnogram waveform.
Another advantage resides in more accurate respiratory system status information from capnogram data.
A given embodiment may provide none, one, two, more, or all of the foregoing advantages, and/or may provide other advantages as will become apparent to one of ordinary skill in the art upon reading and understanding the present disclosure.
The invention may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention.
In some embodiments disclosed herein, parameter quality indices are computed to quantitatively assess the reliability of the respiratory rate (RR) and end-tidal CO2 (etCO2) evaluated from the capnogram. A respiratory well-being index (RWI) may also be computed, based in part on the etCO2 parameter quality index (etCO2 PQI) and the RR parameter quality index (RR PQI). These parameter quality indices enable medical personnel to interpret the capnogram using conventional tools, especially the RR and etCO2, but provide metrics (the quality control indices) to assist medical personnel in assessing whether the RR and etCO2 are reliable data for making clinical decisions.
Further, in some embodiments the parameter quality indices are computed at least in part using a histogram of CO2 value counts versus (binned) CO2 level. This histogram is computed over a time interval encompassing several breaths. For example, the histogram is acquired over a 30 second time interval in one illustrative embodiment, which corresponds to about 6-10 breaths for a normal adult patient respiration interval of 3-5 seconds/breath (12-20 breaths per minute), up to 30 breaths for a rapidly respiring infant (respiration rate of 60 breaths per minute).
Advantageously, the capnogram histogram is computed without segmenting the waveform into different regions (e.g. inspiration, expiration) and without segmenting individual breath cycles (that is, without a breath detector). The capnogram histogram advantageously has a “standard” shape for a normally respiring patient, due to the typical capnogram pattern in which the CO2 level is close to zero during the inspiration phase and close to its maximum (i.e. close to etCO2 for the patient) during the expiration phase. These two phases define respective low and high regions of the disclosed capnogram histogram, with a third transitional histogram region in-between. Rich information about the capnogram waveform can be extracted from the capnogram histogram, without reliance upon the difficult and often imprecise task of segmenting the capnogram waveform into breath cycles which are then further segmented into inspiration and expiration time intervals. In particular, the etCO2 PQI is computed primarily or entirely using the histogram. In some embodiments the etCO2 PQI is computed further based on capnogram characteristics that can be quantified without segmenting the capnogram into inspiration and expiration regions. Illustrative embodiments of the RR PQI do rely upon breath detection and capnogram waveform segmentation, as the RR is intimately associated with (indeed defined by) the breath cycle. However, the RR PQI is optionally further based on the etCO2 PQI thereby incorporating waveform information from the capnogram histogram.
The RWI is computed based on the etCO2 and RR values, and further based on the etCO2 PQI and RR PQI. Incorporating the PQI values into the RWI captures the recognition herein that a poor capnogram waveform is often an indication of poor respiratory health, rather than being an indicator of a capnograph measurement problem.
With reference to
The illustrative capnograph device 10 has a sidestream configuration in which respired air is drawn into the capnograph device 10 using the pump 22, and the CO2 measurement cell 20 is located inside the capnograph device 10. That is, the sidestream capnograph device 10 includes, as a unit, the carbon dioxide measurement component 20, the electronic processor 30, and the pump 22 connected to draw respired air though the carbon dioxide measurement component 20. The sidestream configuration is suitably used for a spontaneously breathing patient, i.e. a patient who is breathing on his or her own without assistance of a mechanical ventilator. In an alternative configuration, known as a mainstream configuration (not illustrated), the CO2 measurement cell is located externally from the capnograph device housing, typically as a CO2 measurement cell patient accessory that is inserted into the “mainstream” airway flow of the patient. Such a mainstream configuration may, for example, be employed in conjunction with a mechanically ventilated patient in which the CO2 measurement cell patient accessory is designed to mate into an accessory receptacle of the ventilator unit, or is installed on an airway hose feeding into the ventilator. The disclosed approaches for quantitatively assessing parameter quality and patient respiratory well-being are readily applied either in conjunction with a sidestream capnograph device (as in the illustrative example of
With continuing reference to
The capnograph electronics 30 may be variously implemented, such as by a suitably programmed electronic processor, e.g. a microprocessor or microcontroller of the capnograph 10. While a single electronics unit 30 is illustrated, it is alternatively contemplated to employ various combinations of electronics, for example different electronic components may be operatively interconnected to implement a pump, power supply, infrared light source and detector, power supply (for the CO2 measurement cell 20), analog-to-digital conversion circuitry (to sample the infrared light detector of the CO2 measurement cell 20), and so forth. Still further, it is contemplated for the electronics that perform the capnograph data processing to be disposed outside of the capnograph device itself. For example, the capnograph data processing may be performed by electronics in another device (for example, the computer of a nurses' station that receives the CO2 signal from the measurement cell 20, or that receives a capnogram generated by the capnograph device and performs further processing). It will be still further appreciated that the capnograph data processing disclosed herein as being performed by the capnograph electronics 30 may be embodied by a non-transitory storage medium storing instructions that are readable and executable by the microprocessor, microcontroller, or other electronic processor to perform the disclosed capnograph data processing. Such non-transitory storage media may, by way of non-limiting illustration, include a hard disk drive or other magnetic storage medium, a flash memory, read-only memory (ROM) or other electronic storage medium, an optical disk or other optical storage medium, various combinations thereof, or so forth.
With continuing reference to
With continuing reference to
The capnogram histogram of a typical capnogram has certain characteristics. The histogram for a typical capnogram will have a higher number of occurrences of CO2 sample values in the bins of Region R1 and Region R3, and the number of occurrences in the bins of Region R2 should be lower than the number of occurrences in Regions R1 and R3. That is, the capnogram histogram 42 has a peak in lower Region R1 and a peak in upper Region R3, and a valley in the intermediate Region R2. Further, the peak in upper Region R3 is typically more spread-out than the peak in Region R1, as seen in the idealized capnogram histogram 42 of
The capnogram histogram 42 is computed from the capnogram 40 in the sliding window, with a new histogram computed every few seconds, e.g. every 5 seconds in one illustrative example employing a 30 second window. There is no attempt to synchronize the window with an integer number of breaths, but the window is preferably large enough to encompass several breaths (e.g. for a normal adult patient respiration interval of 3-5 seconds/breath the illustrative 30 sec window encompasses 6-10 breaths). By re-computing the histogram on a shorter time interval than the window size (e.g. every 5 sec using a 30 sec window) the successive histogram windows significantly overlap providing for a smoothing effect as a function of time. Since there is no synchronization with the breath cycling, there is no need to employ a breath detector in constructing the capnogram histogram 42, and the determination of the histogram 42 is a very fast CO2 sample binning process.
An end-tidal carbon dioxide (etCO2) value and a respiratory rate (RR) value are determined from the capnogram signal 40. Substantially any technique to detect a signal maximum can be used to detect the etCO2 value. For example, in some embodiments, the etCO2 value is determined from the capnogram signal 40 by analysis of the histogram 42 derived from the capnogram signal 40. In this approach, the CO2 level of the highest CO2 level bin having a non-zero sample count provides an etCO2 value. Similarly, substantially any technique to determine periodicity of a signal can be used to detect the RR value. For example, the RR value can be determined by detecting breaths using the breath detector 48 and thereby determining breath intervals (the RR being the inverse of the average breath interval). Alternatively, a Fast Fourier Transform (FFT) can be applied to determine the RR value in the frequency domain.
With continuing reference to
The metric of the portion of the histogram 42 that is above the baseline characterizes the portion of the histogram that is in Region R3 as compared with Region R1. This metric is large for a normal capnogram, but may be low in the case of a poor capnogram waveform having an inconsistent expiratory plateau.
The metric of the difference between the maximum CO2 in Region R3 and the CO2 level in Region R3 having the highest histogram counts is expected to be small because the end-tidal point should have the largest CO2 value and a CO2 level bin at or close to etCO2 should also have a large number of counts since the expiratory plateau usually flattens as it approaches the end-tidal point. This metric may be computed from the difference between the CO2 level of the bin of Region R3 having a non-zero count and the CO2 level of the bin of Region R3 storing the highest count.
The metric comparing the upper Region R3 count versus the intermediate Region R2 count quantifies the expectation that a sharp transition should be present from the inspiratory phase to the expiratory phase in the capnogram 40. In such a case, the intermediate Region R2 count is low and the upper Region R3 count is high. However, since there are more bins in intermediate Region R2 than in upper Region R3, this metric may preferably be quantified using the average count over all bins of Region R2, and likewise using the average count over all bins of Region R3.
The metric of the fraction of the total counts in upper Region R3 should be high since a large portion of the capnogram waveform consists of the expiratory phase. This metric may be computed using the ratio of the total counts in upper Region R3 to the total counts in the capnogram histogram 42.
With brief reference to
It will be noted that the CO2 fall time can be determined without performing breath detection, and without segmenting the capnogram waveform into inspiratory and expiratory phases. For example, in the illustrative example the CO2 fall time is computed by identifying when a high CO2 level falls below Tupper and then when it falls below Tlower.
With returning reference to
where the index i ranges over the metrics contributing to etCO2 PQI 44, Si is the score (i.e. value) of the ith metric, and Wi is a weight for the ith metric. The weights may be generated manually (e.g. based on assessment by a skilled pulmonologist of the relative importance of the various metrics) or by performing machine learning using a training set of representative capnograms each labeled by a skilled pulmonologist as to reliability of the etCO2 value obtained from the training capnogram.
The five metrics contributing etCO2 PQI in the example are merely illustrative. More generally, it will be appreciated that the capnogram histogram 42 is expected to exhibit a large narrow peak in a lower Region R1 corresponding to the inspiration phase of the respiratory cycle, a large slightly broader peak in an upper Region R3 corresponding to the expiratory phase, and a deep valley in an intermediate Region R2 corresponding to transitions from inspiration-to-expiration and from expiration-to-inspiration. Deviations from this basic histogram shape are expected when the capnogram waveform is degraded, and consequently etCO2 values are expected to be less reliable. Various metrics can be constructed and optimized using histograms constructed for training capnograms in order to quantitatively characterize metrics to assess the histogram shape and hence the capnogram waveform. The optimal choice of metrics, and their weights, depends on the capnograph device and its connection to the patient, the demographic being monitored, the desired sensitivity (e.g. how “bad” should the capnogram waveform be before the etCO2 PQI starts to significantly decrease), and so forth. In some embodiments the metrics may be optimized for different patient connections (e.g. nasal cannula versus airway adaptor), different patient breathing conditions (e.g. spontaneous breathing versus various mechanical ventilation modes), or so forth. The capnogram histogram shape reflects the capnogram waveform, so quantitative metrics of the histogram provide assessment of the capnogram waveform quality without the need to detect breath intervals in the capnogram and without the need to segment the capnogram into inspiration and expiration phases. In the illustrative example, one metric (CO2 fall time) is extracted directly from the capnogram 40 rather than from the capnogram histogram 42, but this is still done without performing breath detection or segmenting the capnogram into breathing phases. The computations are fast, and can be performed in real-time (that is, with a delay of a few tens of seconds, a few seconds, or less).
With continuing reference to
In the illustrative embodiment of
The RR PQI 46 is again suitably computed as a weighted sum of the contributing metrics:
where the index i ranges over the metrics contributing to RR PQI 46, Si is the score (i.e. value) of the ith metric, and WW is a weight for the ith metric. The weights again may be generated manually or by performing machine learning using a training set of representative capnograms labeled as to RR reliability. The metrics contributing RR PQI in the example are again merely illustrative, and additional or other metrics are contemplated.
In some embodiments, a respiratory well-being index (RWI) 50 is also computed, which represents a quality score to assess the respiratory well-being of a patient using the capnogram 40. The RWI 50 is designed to help medical personnel evaluate the overall respiratory well-being of the patient. RWI 50 may also be used to identify non-intubated patients who are at risk for hypoventilation due to central or obstructive apnea, such as during procedural sedation. In a suitable embodiment, metrics that serve as weighted inputs to the RWI 50 include the measured RR and etCO2 and the corresponding RR PQI 44 and etCO2 PQI 46. In general, if either the RR or etCO2 are outside their respective normal ranges then this lowers the RWI 50. A lower RR PQI 44 or lower etCO2 PQI 46 also lowers the RWI 50. In some embodiments, a time-since-last-breath metric is also incorporated into the RWI 50 in order to facilitate its use in detecting airway obstruction or apnea episodes. For example, the time-since-last-breath may be quantified from the capnogram 40 by a block 52 assessing the time since last elevated CO2 level.
The indices 44, 46, 50 are suitably re-calculated each time the capnogram histogram 42 is updated, e.g. every 5 seconds in the illustrative example. Since the illustrative histogram calculation window is 30 seconds, the first calculation of the indices 44, 46, 50 is performed after 30 seconds of the capnogram 40 are acquired.
If the capnograph device 10 is programmed to provide informational messages based on the RR and etCO2 values, then the indices 44, 46, 50 may optionally be used to suppress these informational messages when the underlying RR or etCO2 is unreliable as indicated by the corresponding PQI. By way of non-limiting illustration, in one contemplated embodiment the messaging scheme of Table 1 is employed, with the outputs only being displayed when RWI is lower than some threshold value.
In this illustrative messaging scheme, the “patient anxious” message is suppressed if the RR PQI 46 is below a threshold value.
In addition to (or in place of) computing and displaying (on the display component 32) values of probative parameters such as etCO2, RR, etCO2 PQI 44, RR PQI 46, and/or RWI 50, it is contemplated to display on the display component 32 the capnogram histogram 42 itself. As previously discussed, the capnogram histogram 42 embodies substantial information about the capnogram waveform in a format that may be more readily perceived by medical personnel as compared with reading a display of the capnogram 40 (which may optionally also be displayed on the display 32, e.g. as a trend line). One advantage of displaying the capnogram histogram 42 as compared with displaying a trend line of the capnogram 40 is that the trend line is typically scrolled horizontally, whereas the capnogram histogram 42 does not scroll and is updated, e.g. every 5 seconds with substantial overlap between successive updates due to the large window overlap between successive updates (e.g. with a 30 second window and 5 sec updates, each successive histogram is derived from 25 seconds of the same capnogram data that was used to generate the immediately previous histogram and only 5 seconds of new capnogram data).
The invention has been described with reference to the preferred embodiments. Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2016/054469 | 7/27/2016 | WO | 00 |
Number | Date | Country | |
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62203416 | Aug 2015 | US |