WO2020120345A1 - Système et procédé d'optimisation d'enregistrement de résolution de paramètres - Google Patents

Système et procédé d'optimisation d'enregistrement de résolution de paramètres Download PDF

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Publication number
WO2020120345A1
WO2020120345A1 PCT/EP2019/084110 EP2019084110W WO2020120345A1 WO 2020120345 A1 WO2020120345 A1 WO 2020120345A1 EP 2019084110 W EP2019084110 W EP 2019084110W WO 2020120345 A1 WO2020120345 A1 WO 2020120345A1
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Prior art keywords
parameter
recording
physiological parameter
paper
parameters
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PCT/EP2019/084110
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English (en)
Inventor
Sujitkumar Sureshrao HIWALE
Hemant MISRA
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Koninklijke Philips N.V.
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Publication of WO2020120345A1 publication Critical patent/WO2020120345A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/0255—Recording instruments specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/333—Recording apparatus specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/339—Displays specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7232—Signal processing specially adapted for physiological signals or for diagnostic purposes involving compression of the physiological signal, e.g. to extend the signal recording period

Definitions

  • the invention relates to a system and a method for optimizing the recording resolution of the physiological parameters, and more particularly to optimizing the recording resolution by controlling the paper speed for recording the physiological parameters.
  • Pathological or a clinical condition of a person is often determined from the physiological parameters. These physiological parameters, generally referred as parameters, are monitored over a period of time to provide an instinct on the pathological or clinical condition. Visualization of these parameters is imperative to comprehend the pattern related thereto, which becomes critical in determining the pathological or clinical condition.
  • Visualization of the parameters may be effected in various form or manner viz. on a display, print on a paper etc.
  • visualization of parameters recorded or printed on paper is quite common, and widely used.
  • the recording speed on the paper or simply the paper recording speed is crucial as it significantly impacts the resolution of the parameters been recorded or printed on the paper or of its appearance thereof.
  • Slow paper recording speed though being cost effective in terms of paper usage etc.; it has a greater disadvantage compromising on the resolution of the parameters.
  • more details relating to the parameters are recorded in a smaller space, when the paper recording speed is set low. This leads to error in interpretation of the pathological or clinical conditions based on the recorded parameters.
  • the paper recording speed may either be set low or high, at a predetermined value, based on the condition of the person prevalent before the recording of the parameters or based on the need, as the case may be. The entire recording procedure continues with this predetermined speed that been set.
  • US 4S69496 disclose a high speed transcription of physiological data recorded at a lower speed, and transcribing the light signals onto a light-sensitive media at higher speed for recording such physiological data. It does not relate to paper recording speed nor provide hint on the impact of other related parameters on the parameter being recorded.
  • the present invention provides a system for optimizing recording resolution of parameters.
  • the system of the invention comprises at least one monitoring unit, a memory unit and a control unit.
  • the monitoring unit is provided for monitoring at least one of the parameter and/or corresponding associate parameter.
  • the associate parameter being a parameter related to the parameter being recorded.
  • a memory unit is provided for storing information pertaining to at least one of the parameter and/or associate parameter.
  • a control unit is provided for controlling the paper recording speed for optimizing recording resolution of the parameter. The controlling of the paper recording speed is achieved based on the parameter and/or associate parameter, before and/or during the recording of the parameter.
  • the memory unit is provided for storing and providing the parameter and/or associate parameter. These parameters pertain to current and/or previous measurements of the present person or the corresponding like person.
  • control unit is configured to analyze at least one of the parameter and/or associate parameter.
  • the analysis is performed to determine the paper recording speed and of optimizing recording resolution of the parameter thereof, before and/or during the recording of the parameter.
  • the paper recording speed is controlled dynamically, wherein the actuating unit or means effects the paper recording speed in a controlled manner.
  • the monitoring unit is provided to monitor the parameter or associate parameter in real time and/or offline.
  • the monitoring may be performed continuously or periodically as needed.
  • the parameter or associate parameter referred herein throughout the invention include but not limited to parameters or measurements related thereto, such as fetal heartbeat, uterine contraction, blood pressure, pulse rate, temperature, cervical dilation, ECG, etc.
  • control unit has a model to estimate or predict pathological or clinical event requiring increased recording resolution of the parameter based on the parameter and/or associate parameter, before and/or during the recording of the parameter.
  • the invention also provides a method for optimizing recording resolution of parameters.
  • the method of the invention comprises the steps of monitoring the parameter, storing information and controlling the paper recording speed.
  • the step of monitoring the parameter purports to monitoring at least one of the parameter and/or corresponding associate parameter related to the said parameter.
  • the step of storing information relates to storing information pertaining to at least one of the para meter and/or the associate parameter.
  • the step of controlling the paper recording speed relates to controlling the paper recording speed for
  • the step of monitoring the parameter or associate parameter is performed in real time and/or offline.
  • the monitoring may be performed continuously or periodically as needed.
  • the parameter or associate parameter referred herein throughout the invention include but not limited to parameters or measurements related thereto, such as fetal heartbeat, uterine contraction, blood pressure, pulse rate, temperature, cervical dilation, ECG, etc. These parameters pertain to current and/or previous measurements of the present person or the corresponding like person.
  • the step of storing purports to storing and providing the parameter and/or associate parameter.
  • the step of controlling includes analyzing at least one of the parameter and/or associate parameter.
  • the step of analyzing is performed to determine the paper recording speed and of optimizing recording resolution of the parameter thereof, before and/or during the recording of the parameter.
  • the paper recording speed is controlled dynamically, wherein effecting the paper recording speed in a controlled manner through an actuating unit or means.
  • the step of controlling includes estimating or predicting pathological or clinical event requiring increased recording resolution of the parameter based on the parameter and/or associate parameter by a model, before and/or during the recording of the parameter.
  • Figure 1 shows a system for optimizing recording resolution of parameters, in accordance with the invention
  • Figure 2 shows a method for optimizing recording resolution of parameters, in accordance with the invention
  • Figure 3 shows a flowchart illustrating the decision of the control unit of the system of Figure 1;
  • FIG. 4 shows a system for optimizing recording resolution of parameters with reference to Cardiotocography (CTG), in accordance with an exemplary embodiment of the invention
  • Figure 5 shows a flowchart illustrating the decision of the control unit of the system of Figure 4.
  • Figure 6a-c depicts the recording of Fetal Heart Rate (FHR), wherein a false negative condition is encountered with low paper recording speed;
  • Figure 7a-c depicts the recording of Fetal Heart Rate (FHR), wherein a false positive condition is encountered with low paper recording speed;
  • Figure 8a-c depicts the recording of Fetal Heart Rate (FHR), wherein a normal condition is encountered.
  • FHR Fetal Heart Rate
  • CCG Cardiotocography
  • ECG Electrocardiography
  • the clinicians use these graphical records for differentiating normal variations from pathological complications by identifying rate, rhythm, patterns and or combinations of physiological parameters. It has been shown that high subjectivity in visual analysis of these patterns is responsible for high inter-observer as well as intra-observer variations in interpretation, leading to adverse outcomes. For example, it is well documented that the high variability in interpretation is one of the prime factors responsible for poor outcome of CTG.
  • Paper recording speed greatly affects the appearance of physiological parameters or their patterns, by virtue of change in resolution of the recording of parameters. With low paper recording speed, parameters are printed in a small area of the graph and therefore appear very closely placed. This makes it difficult to identify small changes or variations in the parameters been recorded.
  • high speed offers an advantage of better or improved resolution but consumes more paper, printing ink and power. High paper recording speed, by virtue of their better resolution are more helpful in identifying pathological conditions more quickly and reliably. This is the reason clinician prefer graph with a higher resolution for detecting pathological conditions, especially for complicated or high risk case.
  • CTG is usually printed at a paper recording speed of 1, 2 or 3 cm/minute; however, the paper speed varies from country to country and from hospital to hospital.
  • Various CTG guidelines also lack consensus on a preferred paper speed for a CTG recording.
  • Most of the countries in the Europe use 2 cm/minute, while in North America and Japan 3 cm/minute is the common paper recording speed.
  • the speed of 1 cm/minute minimizes the paper requirement and therefore is the most preferred in the developing countries; however, it provides a poor resolution of CTG features and of the recorded parameters thereof.
  • High paper recording speed of CTG provides a better resolution and is capable of identifying even small changes or variations in the CTG pattern.
  • routine paper speed for ECG is 25 mm/second, but in high risk or complicated case it may increase to 50 mm/second to print waveforms more prominently for better visualization.
  • the invention proposes a system to optimally control and manage paper recording speed and of the paper usage and of the resolution of the parameters, before recording of the parameters and/or during the recording of the parameters.
  • the solution optimizes the paper recording speed before start of a recording and during recording based on certain parameters or their combination thereof.
  • the system Before start of recording, the system first analyses the history and clinical parameters of particular case and/or the like case, to estimate the probability of complication that may be anticipated or expected. If the probability of complications expected is higher than a certain threshold, then paper recording speed is set to a higher value for obtaining better resolution of the parameters to be recorded. For cases with a low probability, to optimize paper usage and of other resources, recording may be initiated with a low paper recording speed, unless it is recommended to use higher paper recording speed for better resolution.
  • the system continuously and dynamically monitors its rate, rhythm and pattern. Along with these parameters, other associate parameters like vital parameters and complications occurred during recording are also continuously monitored by the system. When any of these parameter(s) and/or of its pattern(s) are out of predefined normal range or resembles pathological conditions, then the system changes the paper recording speed to a higher value. This is done so as to capture these events with a better resolution, which could be beneficial for a clinician to make interpretation or inference more accurately.
  • the change in paper recording speed is indicated to the user by audio-visual indication or by any other means, and it is also printed on the paper.
  • the system may change the paper recording speed to its previous value. This way, the system optimizes paper usage, printing ink, power and other resources, to render the recording of the parameters more cost effective and more importantly with better and improved recording resolution of the physiological parameters.
  • FIG. 1 shows a system (100) for optimizing recording resolution of parameters, in accordance with the invention.
  • the system (100) of the invention comprises a monitoring unit (101), a memory unit (102), a control unit (103), a user interface (104) and a recording unit (105).
  • At least one monitoring unit (101) is provided for monitoring and acquiring parameter and/or its associate parameter.
  • An independent or dedicated monitoring unit may be provided to monitor and acquire each of the parameter or associate parameter.
  • One or more of such monitoring unit (101) having capability to monitor and measure one or more of parameter and/or associate parameter, depending upon the feasibility may be employed.
  • the parameter referred herein relate to the physiological parameter that is subject for recording
  • the associate parameter refers to one or more parameters that relate directly or indirectly to the parameter subject for such recording.
  • These parameter and/or associate parameter may include but not limited to fetal heartbeat, uterine contraction, blood pressure, pulse rate, temperature, cervical dilation, ECG etc.
  • a memory unit (102) is provided for storing and providing the parameter and/or associate parameter pertaining to the current ongoing monitoring and measurement or of the previous measurements or information from the person's medical history. Similar information regarding the parameter and/or associate parameter from previous history made available with respect to other person of similar or like medical condition relevant to the current circumstances may also be used more meaningfully taking it into consideration towards optimizing recording resolution of the parameter.
  • the parameter and/or associate parameter monitored and measured by the monitoring unit (101) is provided to the memory unit (102) for storing therein and for further use thereof.
  • a user interface (104) is provided to establish an interface between the user and one or more of the monitoring unit (101), memory unit (102) and control unit (103). User may provide inputs relating to threshold limits, patient record information etc. or any other data that is relevant to the said purpose.
  • a control unit (103) is provided to determine the paper recording speed.
  • the control unit (103) is provided to determine the paper recording speed.
  • the control unit (103) analyses the data or information referred above to determine the paper recording speed, before the recording of the parameter is initiated. This is performed by the control unit (103) in order to analyze the event or series of event associated with the medical condition and of the recording of the parameter thereof. Such analysis is performed to predict or anticipate occurrence of any abnormal event or situation regarding the medical or pathological or clinical condition, duly considering the data and/or information provided to the control unit (103). These conditions may be referred herein simply as medical condition. Accordingly, the control unit (103) determines the paper recording speed based on the normality or abnormality of the medical condition. The paper recording speed is set low or as recommended for normal condition, or may be increased to a higher paper recording speed either linearly or in step for abnormal condition.
  • Such analyses, and of the determination of the paper recording speed may be done dynamically in real time or offline, and before the initiation of recording of the parameter or during the recording.
  • the paper recording speed may be changed from low to high or vice-versa or may be maintained at a constant low or high speed as determined by the control unit (103).
  • a recording unit (105) is provided to effect the actual recording of the parameter based on the paper recording speed determined by the control unit (103). Such recording of the parameter is made on a suitable paper for visual representation of the recorded parameter for further medical investigation or interpretation.
  • Figure 2 shows a method (200) for optimizing recording resolution of parameters, in accordance with the invention, performed the system of the invention.
  • the method (200) comprises the steps of monitoring the parameter (201), providing information (202), and controlling the paper recording speed (203).
  • the step of monitoring the parameter (201) purports to monitoring and acquiring parameter and/or its associate parameter, by the monitoring unit (101).
  • the step of providing (202) relates to storing and providing the parameter and/or associate parameter, by the memory unit (102).
  • the step of providing parameter and/or associate parameter is to make available the same to the control unit (103) for controlling the paper recording speed.
  • the step of providing (202) as herein described include storing (202a) of the parameter and/or associate parameter in the memory unit (102). These parameters may be stored and provided in real time or offline, in respect of current monitoring (201) and/or from the previous data relating to the parameter and/or associate parameter.
  • the step of controlling the paper recording speed (203) includes analyzing (203a) the parameter and/or associate parameter.
  • the step of controlling (203) also includes estimating the paper recording speed (203b).
  • the method of the invention is performed before and/or during the recording of the parameters.
  • FIG. 3 shows a flowchart (300) illustrating the decision making by the control unit (103) of the system (100).
  • the flowchart (300) shows several steps involved in the process of decision making between the start (300a) and end (300b) steps.
  • the step of obtaining data or information relevant to the medical condition and medical history (301) of the person or of the like person with similar medical condition is followed by the analysis of such data or information (302a) by the control unit (103).
  • the analysis is performed by the control unit (103) to determine if the medical condition has a risk or complication.
  • risk Upon determination of risk (303), if it is found to have a risk, the paper recording speed is set to a higher value (304).
  • the paper recording speed is set to a lower or recommended value (305).
  • Analysis to determine the risk involved in respect of a medical condition include predicting the events and occurrence that is not currently present or foreseen.
  • monitoring one or more of the parameters and/or associate parameters (306) is performed by the monitoring unit (101).
  • analysis is performed on them (302b) by the control unit (103).
  • the current medical condition is evaluated to be either normal or abnormal (307). If found abnormal, the paper recording speed is set to a higher value (308). However, if the condition is normal, the paper recording speed is set to low (309).
  • the above said risk determination and evaluation of abnormality may be repeated iteratively or continuously in real time or offline.
  • the information and of the analysis made herein is stored periodically or continuously (310).
  • Cardiotocography CCG
  • Figures 4 to 8 The invention is further described hereinafter in accordance with a non-exhaustive exemplary embodiment pertaining to Cardiotocography (CTG) and with reference to Figures 4 to 8.
  • CTG is a continuous graphical record of fetal heart beats along with maternal uterine contraction activity.
  • the upper half of the graph consists of recorded fetal heart beats, while the lower half simultaneously shows recorded maternal uterine contractions.
  • FIG. 4 shows a system (400) for optimizing recording resolution of parameters with reference to Cardiotocography (CTG), in accordance with a non-exhaustive exemplary embodiment of the invention.
  • CCG Cardiotocography
  • the system (400) of the invention comprises a monitoring unit (401a and 401b), a memory unit (402), a control unit (403), a user interface (404) and a recording unit (405).
  • the monitoring unit (401a) is provided for monitoring and acquiring parameter and/or its associate parameter relating to the maternal parameters, herein after referred as maternal parameters.
  • An independent or dedicated monitoring unit (401a) may be provided to monitor and acquire each of the maternal parameter.
  • One or more of such monitoring unit (401a) having capability to monitor and measure one or more of maternal parameters, depending upon the feasibility may be employed.
  • monitoring unit (401b) is provided for monitoring and acquiring parameter and/or its associate parameter relating to the fetal parameters, herein after referred as fetal parameters.
  • An independent or dedicated monitoring unit (401b) may be provided to monitor and acquire each of the fetal parameter.
  • One or more of such monitoring unit (401a) having capability to monitor and measure one or more of fetal parameters, depending upon the feasibility may be employed.
  • the maternal parameters include but not limited to uterine contraction signal, maternal blood pressure, pulse rate, temperature, cervical dilation, ECG etc.
  • the fetal parameters include but not limited to Fetal Heart Rate (FHR), fetal movements and fetal ECG etc.
  • a memory unit (402) is provided for storing and providing the maternal and fetal parameters and/or their associate parameter pertaining to the current ongoing monitoring and measurement or of the previous measurements or information from the person's medical history. Similar information regarding the maternal and fetal parameters and/or their associate parameter from previous history made available with respect to other person of similar or like medical condition relevant to the current circumstances may also be used more meaningfully taking it into consideration towards optimizing recording resolution of the parameter.
  • the maternal and fetal parameters and/or their associate parameters monitored and measured by the monitoring unit (401a and 401b) are provided to the memory unit (402) for storing therein and for further use thereof.
  • a user interface (404) is provided to establish an interface between the user and one or more of the monitoring unit (401a and 401b), memory unit (402) and control unit (403). User may provide inputs relating to threshold limits, patient record information etc. or any other data that is relevant to the said purpose.
  • a control unit (403) is provided to determine the paper recording speed.
  • the control unit (403) analyses the data or information purporting to the maternal and fetal parameters and/or their associate parameters provided by one or more of the monitoring unit (401a and 401b), memory unit (402) and user interface (404).
  • the control unit (403) analyses the data or information referred above based on certain parameters or of their combination, to determine the paper recording speed, before the recording of the parameter is initiated. This is performed by the control unit (403) in order to analyze the event or series of event associated with the medical condition and of the recording of the parameter thereof. Such analysis is performed to predict or anticipate occurrence of any abnormal event or situation regarding the medical or pathological or clinical condition, duly considering the data and/or information provided to the control unit (403). These conditions may be referred herein simply as medical condition. Accordingly, the control unit (403) determines the paper recording speed based on the normality or abnormality of the medical condition. The paper recording speed is set low or as recommended for normal condition, or may be increased to a higher paper recording speed either linearly or in step for abnormal condition.
  • Such analyses, and of the determination of the paper recording speed may be done dynamically in real time or offline, and before the initiation of recording of the parameter or during the recording.
  • the paper recording speed may be changed from low to high or vice-versa or may be maintained at a constant low or high speed as determined by the control unit (103).
  • a recording unit (405) is provided to effect the actual recording of the parameter based on the paper recording speed determined by the control unit (403). Such recording of the parameter is made on a suitable paper for visual representation of the recorded parameter for further medical investigation or interpretation.
  • the control unit analyses the maternal history along with maternal and fetal parameters to assess the pregnancy risk. If pregnancy is found to be of high risk, then the paper recording speed is set to a higher value (2 cm/minute or 3 cm/minute) for a better resolution of the recorded parameter. For low risk pregnancies, to optimize paper usage, recordings are started at a low paper speed (lcm/minute), unless it is recommended to use high paper recording speed for a better resolution.
  • the system continuously monitors the FHR and uterine contraction rate and pattern. Along with these parameters, other parameters such as maternal and fetal vital parameters and complications are also continuously monitored. When any of these parameter(s) or pattern(s) is/are out of predefined normal ranges or resembles pathological conditions, then the control unit (403) changes the paper recording speed to a higher value (2 cm/minute or 3
  • FIG. 5 shows a flowchart (500) illustrating the decision making by the control unit (403) of the system (400).
  • the flowchart (500) shows several steps involved in the process of decision making between the start (500a) and end (500b) steps.
  • the step of obtaining medical and pregnancy history (501) of the person or of the like person with similar medical condition is followed by the analysis of such data or information (502a) by the control unit (403).
  • the analysis is performed by the control unit (403) to determine if the medical condition has a risk or complication related to pregnancy (503).
  • risk Upon determination of risk (503), if it is found to have a risk, the paper recording speed is set to a higher value (504). On the other hand, if the risk is not significant or if the risk is not present, the paper recording speed is set to a lower value or recommended value (505).
  • FHR Fetal Heart Rate
  • Uterine Contraction signal 506
  • the analysis is performed by the control unit (403) to determine if there is any abnormality (507).
  • the paper recording speed is set to a higher value (508).
  • the paper recording speed is set to a lower value or recommended value (509).
  • monitoring maternal and fetal parameters is followed by the analysis of these data or information (502c) by the control unit (403). The analysis is performed by the control unit (403) to determine if there is any abnormality (511). Upon determination of abnormality (511), if it is found to have an abnormality, the paper recording speed is set to a higher value (512). On the other hand, if the abnormality is not significant or if the abnormality is not present, the paper recording speed is set to a lower value or recommended value (513).
  • the step of monitoring Fetal Heart Rate (FHR) and Uterine Contraction signal (506), Monitoring maternal and fetal parameters (510), and above said risk determination and evaluation of abnormality is continuous and/or iterative throughout the recording of CTG. Also, the data or information purporting to monitoring, medical history and as encountered in any of the step before or during the recording are stored (514) in the memory unit (402).
  • the invention is explained herein after, in general, with reference to before and during the recording in the context of CTG.
  • the invention optimizes the paper recoding speed before start of a recording and if required during recording.
  • the optimal recording speed for a particular case is determined based on maternal, fetal parameters and history.
  • the maternal parameters include but not limited to maternal age, gravida, parity, height, weight, previous pregnancy history, current pregnancy history, gestational age, ultrasound parameters, investigation results, clinical risk assessment, associated complications, diagnosis, treatment received etc. All these parameters are entered through the User interface component or directly passed to the Control unit by electronic medical record system of any other digital recording system.
  • Predicting a chance of maternal and fetal complications during intrapartum phase is very important for deciding optimum CTG paper recording speed. For a given population or geography, using past records and published data, it is possible build a mathematical model to estimate pregnant ladies that are more likely to suffer from intrapartum complications based on their history and other clinical parameters.
  • the model for computing intrapartum complication is driven at two levels viz. population level and user level.
  • the data from a large section of the population primarily the historical data is obtained to train a model.
  • This is a data-driven methodology where the experts have reviewed the data at the time of recording or thereafter, and have marked the different sections of the CTG as low, medium or high risk and actual outcomes of the cases are available. This annotated data is used for training the model.
  • the data from a user who is under observation is used to customize the model for the user. This is online adaptation of the model to provide better prediction for each individual.
  • the Control unit estimates a probability of intrapartum complication based on history and clinical parameters. If probability of complication is more than a certain threshold, then the Control unit set the paper recording speed at a higher value for a better resolution.
  • a probability of having intrapartum complications (p) for a case with history of gestational diabetes and abnormal uterine coiling index can be estimated using a multivariate logistic regression model.
  • the optimal paper recording speed for a particular case is determined based on maternal, fetal parameters and history. Based on certain parameters of pregnant women from a historical database a mathematical model can be generated to estimate a probability of certain complications like fetal distress, need of operative delivery etc.
  • the Table 1 shown below illustrates probability of a complication (p) i.e. fetal distress (dependent variable) calculated by a mathematical models based on historical data; probability are calculated with different sets of parameters.
  • This model is based on age of pregnant lady, parity status, sex of the fetus and estimated fetal weight (independent variables).
  • control unit When an estimated probability for intrapartum complication is more than a certain threshold, the control unit will change the paper recording speed accordingly. This can be done in two ways viz. by step increase or by linear increase.
  • step increase for example when probability is more than 0.2 the recording speed will be changed to 2 cm/minute.
  • probability is more than 0.4 the recording speed will be set to 3 cm/minute to capture any small change with a better resolution.
  • the speed will be change to 2 cm/minute.
  • the threshold for such change can be based on importance or severity of a particular complication.
  • the RecordingConstant in turn could be a function of probabilities of other complications such as probability of operative delivery etc. estimated by other models with same or different set of parameters.
  • the 'a' is a coefficient of probability; it can be used to give proper weightage for probability of a particular complication.
  • the final recording speed for a particular case can be based on probability of a particular complication or probabilities of a number of complications. Such change in paper recording speed to a higher value enables to capture any small change with a better or improved resolution.
  • optimizing the paper recording speed is based on two important set of parameters viz. FHR and maternal uterine contraction rate/pattern, and important maternal and fetal parameters and complications encountered.
  • Control unit which first analyses the maternal uterine contraction and FHR signal independently to find out whether they are within predefined normal ranges and/or have normal characteristics. If any one of them is out of a normal range/characteristic for more than certain time duration, then the Control unit assesses the probability of impact of these parameters on intrapartum complications. The Control unit uses the predictive models as described earlier for calculating this probability. If the expected probability of complications is more than a certain threshold the control unit changes the paper recording speed to a higher value (2cm/minute or 3cm/minute) so as to capture these events with a better recording resolution. The change in paper speed is indicated to user by audio-visual indication or the like, by the user interface and it is also printed on the paper.
  • the control unit continuously monitors both maternal uterine contraction and FHR. If their values are back to the normal range and continues being so for certain time duration, then the control unit changes the paper speed to a lower value (1 cm/minute or 2 cm/minute). The change in paper recording speed is indicated to user by audio-visual indication or the like, by the user interface and it is also printed on the paper.
  • the control unit also analyses a relationship pattern between maternal uterine contraction and FHR. If the observed pattern resembles an abnormal pattern for more than certain time duration, then the control unit changes the paper speed to a higher value (2 cm/minute or 3 cm/minute) so as to capture these events with a better or improved resolution.
  • the change in paper recording speed is indicated to user by audio-visual indication or the like, by the user interface and it is also printed on the paper.
  • the Control unit continuously monitors both maternal uterine contraction and FHR patterns. If their patterns are back to normal for certain time duration, then the Control unit changes the paper recording speed to a lower value (1 cm/minute or 2 cm/minute). The change in paper recording speed is indicated to user by audio-visual indication or the like, by the user interface and it is also printed on the paper.
  • the monitoring unit monitors parameters like maternal blood pressure, pulse rate, ECG, temperature etc. These parameters are then provided to the control unit.
  • the control unit analyses whether these parameters are within predefined normal ranges and/or have normal characteristics. If any one of them is out of a normal range / characteristic for more than certain time duration, then the control unit assesses the probability of impact of these parameters on intrapartum complications.
  • the control unit uses the predictive models as described earlier for calculating this probability. If the expected probability of complications is more than a certain threshold the control unit changes the paper recording speed to a higher value (2 cm/minute or 3 cm/minute) so as to capture these events with a better or improved resolution.
  • the change in paper recording speed is indicated to user by audio-visual indication or the like, by the user interface and it is also printed on the paper.
  • the control unit keeps on continuously monitoring these parameters. If their values are back to the normal range and continues being so for certain time duration, then the control unit changes the paper recording speed to a lower value (1 cm/minute or 2 cm/minute). The change in paper recording speed is indicated to user by audio-visual indication or the like by the user interface and it is also printed on the paper. Similarly, the parameter like fetal ECG, fetal movement etc. are monitored. These parameters are then provided to the control unit. The control unit analyses whether these parameters are within predefined normal ranges and/or have normal characteristics. If any one of them is out of a normal range / characteristic for more than certain time duration, then the Control unit assesses the probability of impact of these parameters on intrapartum complications.
  • the control unit uses the predictive models as described earlier for calculating this probability. If the expected probability of complications is more than a certain threshold the control unit changes the paper recording speed to a higher value (2 cm/minute or 3 cm/minute) so as to capture these events with a better or improved resolution.
  • the change in paper recording speed is indicated to user by audio-visual indication or the like, by the user interface and it is also printed on the paper.
  • the control unit continuously monitors these parameters. If their values are back to the normal range and continues being so for certain time duration, then the control unit changes the paper speed to a lower value (1 cm/minute or 2 cm/minute).
  • the change in paper recording speed is indicated to user by audio-visual indication or the like, by the user interface and it is also printed on the paper.
  • control unit analyses these parameters independently and/or in combination to determine an appropriate paper recording speed for a particular case. All the events are stored in the memory unit for future use and reference.
  • the paper recording speed can be changed either in step increase or linear increase.
  • the RecordingConstant could be a function of probabilities of other complications during intrapartum or it could be a function of probabilities of complication before recording, or both.
  • Figure 6 represents the recording of Fetal Heart Rate (FHR), wherein a false negative condition is encountered with low paper recording speed.
  • FHR Fetal Heart Rate
  • Figure 6a the graphical representation of FHR (600a) recorded at a speed of 1 cm/minute is shown in terms of Time (in minutes) against FHR (bpm).
  • the NICHD (National Institute of Child Health and Human Development) guideline recommends determining baseline FHR in an at least 2 minutes of identifiable baseline segments. Baseline is determined by approximating the mean FHR rounded to increments of 5 beats per minute (bpm) during a 10-minute window excluding accelerations and decelerations and periods of marked FHR variability.
  • FIG. 7 represents the recording of Fetal Heart Rate (FHR), wherein a false positive condition is encountered with low paper recording speed.
  • FHR Fetal Heart Rate
  • Figure 7a the graphical representation of FHR (700a) recorded at a speed of 1 cm/minute is shown in terms of Time (in minutes) against FHR (bpm).
  • deceleration should have onset to nadir duration of 30 seconds or more. Due to a low resolution at a recording speed of 1cm/ minute, sometimes it is difficult to determine the exact duration of a deceleration; having too many decelerations in a close group also makes it difficult to distinguish individual decelerations by just visual interpretation.
  • the marked segment (702a) of the signal looks like to have some FHR decelerations. However, when examined at a better resolution (recording at 2 cm/minute) the signal does not contain many decelerations as per the standard FHR guidelines. The better resolution in this case avoids false identification of FHR complications.
  • Figure 8 represents the recording of Fetal Heart Rate (FHR), wherein a normal condition is encountered.
  • FHR Fetal Heart Rate
  • Figure 8a the graphical representation of FHR (800a) recorded at a speed of 1 cm/minute is shown in terms of Time (in minutes) against FHR (bpm).

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Abstract

L'invention concerne un système et un procédé d'optimisation d'enregistrement de résolution de paramètres. Le système (100) comprend au moins une unité de surveillance (101), une unité de mémoire (102) et une unité de commande (103). L'unité de surveillance est prévue pour surveiller au moins l'un du paramètre et/ou de son paramètre associé correspondant. Une unité de mémoire est prévue pour stocker des informations concernant au moins l'un du paramètre et/ou du paramètre associé. Une unité de commande est prévue pour commander la vitesse d'enregistrement de papier pour optimiser la résolution d'enregistrement du paramètre. La commande de la vitesse d'enregistrement du papier est obtenue sur la base du paramètre et/ou du paramètre associé, avant ou pendant l'enregistrement du paramètre ou des deux. Le procédé de l'invention comprend les étapes consistant à surveiller le paramètre, à stocker des informations et à commander la vitesse d'enregistrement de papier. Les étapes du procédé sont en relation correspondante avec les aspects du système de l'invention.
PCT/EP2019/084110 2018-12-11 2019-12-09 Système et procédé d'optimisation d'enregistrement de résolution de paramètres WO2020120345A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230136298A1 (en) * 2021-11-02 2023-05-04 GE Precision Healthcare LLC Deep learning based fetal heart rate analytics

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US3824990A (en) * 1971-06-30 1974-07-23 Instr For Cardiac Res Inc Method and apparatus for producing sample electrocardiograms
US3958563A (en) * 1974-11-06 1976-05-25 Heriberto Fernandez Two speed system for EEG recording
US4090505A (en) * 1976-06-01 1978-05-23 Marquette Electronics, Inc. Electrocardiographic recording method and means
US4369496A (en) 1980-03-07 1983-01-18 Advancemed Apparatus for high-speed transcription of recorded physiological data
US5442940A (en) * 1991-10-24 1995-08-22 Hewlett-Packard Company Apparatus and method for evaluating the fetal condition
US20120257698A1 (en) * 2011-04-06 2012-10-11 Siemens Medical Solutions Usa, Inc. System for Adaptive Sampled Medical Signal Interpolative Reconstruction for Use in Patient Monitoring

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3824990A (en) * 1971-06-30 1974-07-23 Instr For Cardiac Res Inc Method and apparatus for producing sample electrocardiograms
US3958563A (en) * 1974-11-06 1976-05-25 Heriberto Fernandez Two speed system for EEG recording
US4090505A (en) * 1976-06-01 1978-05-23 Marquette Electronics, Inc. Electrocardiographic recording method and means
US4369496A (en) 1980-03-07 1983-01-18 Advancemed Apparatus for high-speed transcription of recorded physiological data
US5442940A (en) * 1991-10-24 1995-08-22 Hewlett-Packard Company Apparatus and method for evaluating the fetal condition
US20120257698A1 (en) * 2011-04-06 2012-10-11 Siemens Medical Solutions Usa, Inc. System for Adaptive Sampled Medical Signal Interpolative Reconstruction for Use in Patient Monitoring

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230136298A1 (en) * 2021-11-02 2023-05-04 GE Precision Healthcare LLC Deep learning based fetal heart rate analytics

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