JPH0975309A - Decision method by automatic analysis of patient's condition by change in measured value of arterial blood oxygen saturation degree and measured value of pulsation - Google Patents

Abstract

PROBLEM TO BE SOLVED: To make it possible to rapidly deal with the announcement of a condition change without the specialized operator by transmitting the artery blood oxygen saturation degree (SpO2 value), etc., measured by the patient himself under a home oxygen therapy to the computer on a hospital side, etc., thereby automatically analyzing the SpO2 value data. SOLUTION: An average ± Pa (2 to 3) × deviation is determined by the average and deviation of the total data of the SpO2 values inputted to the computer in the previous month. If there is the data outside this range, this data is excluded, and further, the average and the corrected deviation are calculated. The variation in the measured values by the individual difference of the patient is then corrected. The lower limit value of the SpO2 of the previous month = the average - Pb (2 to 3) ×deviation is calculated by this average and the deviation and, thereafter, this lower limit value and the transmitted SpO2 values of this month are compared by the computer. When the measured value falls below the lower limit value, the rapid drop of the SpO2 value is decided. The change of the condition is then immediately announced to the hospital side by an alarm, etc.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention provides a home care patient receiving home oxygen therapy so that the hospital side can immediately understand the arterial blood oxygen saturation (SpO ₂ ) and pulse value measured by themselves. The present invention relates to a method capable of determining the condition of a home care patient without a dedicated operator by automatically analyzing a situation in which data such as the SpO ₂ value changes using a computer into which measured values are input.

[0002]

2. Description of the Related Art Patients with an oxygen transport system of the human body, that is, lungs, respiratory organs, or the obstruction of ventilation due to obstruction of the brain, nerves, and airways are continuously treated at home. Home oxygen therapy (HOT) is known. In such a case, the arterial oxygen saturation (SpO ₂ ) of the home care patient, that is, the oxygen capacity (O ₂ ) of the blood that is the amount of oxygen bound to hemoglobin in the arterial blood.
The attending physician must keep track of this percentage and pulse rate. However, in the past, outpatients who were treated at home once or twice a month were subjected to blood gas tests to measure SpO ₂ and pulse values that change as described above. However, it was not possible to grasp the condition on an outpatient day by using such means, and the condition of the patient receiving conventional medical treatment may change suddenly within a few days.

Therefore, in order to solve such a difficulty,
We have already prepared a pulse oximeter that can easily measure SpO ₂ and pulse at the home of a home-care patient, and the measured value data related to these measured by the patient himself can be used in a computer at the hospital of the attending physician by using the telephone line. Transmission is also being developed. However, even when the above-mentioned means is used, even if the SpO ₂ value and the pulse value are input to the computer, based on these transmission data,
In order to judge the condition of the patient, it is necessary for the dedicated operator to be on standby at all times, and even with such an operator, when there is a subtle change in the measurement data, etc. It becomes difficult for the operator to judge the patient's condition.

[0004]

In the present invention, in view of the above-mentioned conventional problems, the SpO ₂ value and the pulse value of the home care patient have individual differences in their average levels and variations, and their condition deteriorates. The changes in the measured value data at the time are as follows: (1) a sudden decrease in the SpO ₂ value,
According to claim 1, there are four patterns: (2) rapid rise of pulse value, (3) gentle fall of SpO ₂ value, and (4) gentle rise of pulse value. Using a computer, obtain the average and deviation of all SpO ₂ values for a predetermined period of time by an appropriate method, use these to calculate the lower limit of the SpO ₂ value in advance, and calculate the lower limit of the SpO ₂ value to the computer. When the transmission SpO ₂ value falls, the computer automatically performs the automatic analysis of (1), which determines that there is a sharp drop, so that a change in the SpO ₂ value data can be accurately known without a dedicated operator. The purpose is to make an immediate decision on the condition of a home care patient so that the attending physician can promptly respond.

In the determination method according to claim 2, it is intended to determine that the pulse value of (2) has risen sharply, and in the same manner as in the above-mentioned claim 1, the predetermined value related to the pulse value is determined. From the average and deviation in the recent period, calculate the upper limit value of the pulse value, when the transmission pulse value input to the computer is higher than the upper limit value, it is determined that there is a sharp rise, It is intended to achieve the same purpose as that of claim 1.

According to the third aspect, the gradual decrease of SpO ₂ in (3) above is determined, and the average and deviation of the SpO ₂ values are obtained as described in the first aspect. This is during a predetermined near-term period, which is slightly before the determination date of the transmission SpO ₂ value, and further, during a predetermined immediately preceding period before the above-mentioned decision date, which does not overlap with this predetermined near-term period at all. With the start point as the origin of the time axis, the Y intercept and the slope are obtained by the least squares method for all SpO ₂ value data in the period. Then, on the premise that the slope is negative and the significance of the slope is confirmed by the test of the slope, the inequality determination formula of average-parameter x deviation> slope x number of days immediately before a predetermined period + Y intercept is satisfied. When it is determined that the SpO ₂ value has fallen gently, the same purpose as in claim 1 can be achieved.

In the case of claim 4, (4)
It is attempting to determine that the pulse value of the pulse has gradually risen, and the average and the deviation of the pulse values are obtained in the same manner as in claim 2 in which the pulse in a predetermined recent period slightly before the transmission pulse value determination date is determined. The least squares method for all the pulse value data is the same as that of the third embodiment, in which the starting point of the predetermined immediately preceding period that does not overlap the predetermined previous period at all is the origin of the time axis. Then, the Y intercept and the slope are obtained. And when this slope is positive and the significance is admitted,
Similarly to the previous case, it is determined that there is a gradual increase in the pulse value by satisfying the condition represented by the average + parameter x deviation <slope x number of days in a predetermined immediately preceding period + inequality determination formula of Y intercept,
This is intended to achieve the same purpose as described in claim 1 above.

[0008]

In order to achieve the above object, the present invention provides, in claim 1, a home-care patient who is receiving home oxygen therapy, measuring his own arterial blood oxygen measured by a pulse oximeter. Saturation (SpO ₂ value) is continuously transmitted to the computer at the required location,
With respect to the transmission SpO ₂ value, the computer calculates the average and deviation of all SpO ₂ value data in a predetermined recent period, and from these averages and deviations, the average ± Pa × deviation with Pa = 2 to 3 as a parameter. Then, within the range of this average ± Pa × deviation, all the above SpO ₂ value data are
If all of them are included, the SpO with the Pb = 2 to 3 in the predetermined near period as a parameter is calculated according to the average and the deviation.
_{2 The} lower limit value of the average −Pb × deviation is calculated, and the above SpO ₂
If all the data include data that is not within the range of ± Pb × deviation, calculate the calibration mean and calibration deviation of SpO ₂ value data excluding the SpO ₂ value until the data is no longer included. Then, the correction average −Pb × correction deviation which is the lower limit value of SpO ₂ is calculated, and the lower limit value of SpO ₂ thus obtained and the transmission which is input to the computer after the predetermined near time period are transmitted. By comparing the SpO ₂ values, the transmitted SpO ₂ value is
Automatic detection of the patient's condition by a change in the arterial blood oxygen saturation measurement value, which is characterized by detecting that the SpO ₂ value of the home care patient has suddenly decreased by detecting that it falls below the O ₂ lower limit value. We are trying to provide a judgment method by analysis.

According to the present invention, the home medical care patient receiving home oxygen therapy continuously transmits his / her own pulse value measured by the pulse oximeter to the computer at a required location, and the transmission is performed. For the pulse value, the computer calculates the average and deviation of all the pulse value data in a predetermined recent period, and from these averages and deviations, the average ± Pc × deviation with Pc = 2 to 3 as a parameter is calculated, and If all of the above pulse value data are included within the range of mean ± Pc × deviation, it is the pulse upper limit value with Pd = 2 to 3 as the parameter according to the mean and deviation. Average + Pd × deviation is calculated, and when all the pulse value data include data that is not within the range of ± Pc × deviation, the pulse value is changed until the data is not included. The calibration average and the calibration deviation of the removed pulse value data are obtained, and the calibration average + Pd × calibration deviation, which is the above-mentioned pulse upper limit value, is calculated, and the pulse upper limit value thus obtained and the predetermined recent period after By comparing the transmission pulse value that is input to the computer, by detecting that the transmission pulse value exceeds the pulse upper limit value, a sudden increase in the pulse value of the home care patient is said to occur. An attempt is made to provide a determination method by automatic analysis of a patient's condition based on changes in pulse measurement values, which is characterized by making it clear.

In the case of the determination method according to claim 3, a home-care patient undergoing home oxygen therapy measures his own arterial oxygen saturation (SpO ₂₎ measured by a pulse oximeter.
Value) is continuously transmitted to a computer at a required location, and for the transmission SpO ₂ value, the average and deviation of all SpO ₂ value data in a predetermined recent period are calculated by the computer. The average ± Pe × deviation with Pe = 2 to 3 as a parameter is calculated from the average and the deviation, and within the range of this average ± Pe × deviation, the SpO
_Binary all data, if it contains any, when the adopted mean and variance when the determination will be described later, the data is not within the range of the average ± Pe × deviation in the SpO ₂ value all data is included , Until the data is no longer included
The calibration average and calibration deviation of SpO ₂ data excluding the O ₂ value are obtained, and the calibration average and calibration deviation are adopted at the time of the determination described later, while the determination date is after the predetermined recent previous period. Taking the start point of the previous immediately preceding predetermined period as the origin of the time axis, the Y intercept and the slope are obtained by the least squares method for all SpO ₂ values over the predetermined immediately preceding period, and if this slope is positive, the SpO ₂ value is gentle. If the above slope is negative, the significance of the slope is tested. If the result is not significant, the SpO ₂ value does not have a gentle downtrend. When the result is judged to be significant, the mean or calibrated average and the deviation or calibrated deviation and the Y intercept and the slope are adopted, and Pf = 2 to 3 is used as a parameter,
Average or calibrated average-Pf x deviation or calibrated deviation> slope x number of days in a predetermined immediately preceding period + inequality of Y intercept is not established, it is determined that the SpO ₂ value does not have a gradual downward trend, and the inequality is determined. When the expression is satisfied, the content is that it is determined that the SpO ₂ value is gradually decreasing.

Further, according to the determination method of claim 4, the home medical care patient receiving the home oxygen therapy continuously transmits his / her pulse value measured by the pulse oximeter to the computer at the required location. Then, with respect to the transmission pulse value, the computer calculates the average and deviation of all pulse value data in a predetermined recent period,
If the average ± Pg × deviation with Pg = 2 to 3 as a parameter is obtained from these averages and deviations, and if all the above pulse value data are included within the range of this average ± Pg × deviation, When the average and the deviation are adopted at the time of the determination described later, and the pulse value all data includes data that is not within the range of ± Pg × deviation, the pulse value is excluded until the data is not included. The correction average and the correction deviation of the value data are obtained, and the correction average and the correction deviation are adopted at the time of the later-described judgment, while the start of the predetermined immediately preceding period after the predetermined near-term previous period described above. With the origin of the time axis as the origin of the time axis, the Y-intercept and the slope are obtained by the least-squares method with respect to the total pulse value over the predetermined period, and if the slope is negative, it is determined that the pulse value does not tend to increase gently. Has a positive slope When, for the slope,
When the result is not significant, it is judged that there is no gradual upward trend in the pulse value, and when the result is significant, the deviation from the mean or calibrated mean Or, the calibrated average and the Y intercept and the slope are adopted, and the inequality judgment formula of the average or the calibrated average + Ph x deviation or the calibrated deviation <slope x the number of days in the immediately preceding predetermined period + the Y intercept is established with Ph = 2 to 3 as parameters. If not, it is determined that there is no gradual increase tendency in the pulse value, and when the inequality determination formula is satisfied, it is determined that the pulse value is in a gentle increase.

[0012]

BEST MODE FOR CARRYING OUT THE INVENTION The determination method according to the present invention can be carried out by using an example of a transmitting apparatus as illustrated in FIG. 2, and in the illustrated example, a home care patient side C has a sensor. On the output side of the pulse oximeter 1 which has derived 1a,
A home transmitter / receiver 3 is connected via the relay box 2, and an output side of the home transmitter / receiver 3 and a telephone 4 are connected to a telephone line 5 by a connector 4a. 1 in the figure
Reference numerals b and 1c respectively indicate a display section and a power switch of the pulse oximeter 1, and 2a and 2b respectively indicate a transmission switch and a measurement pilot lamp of the relay box 2.

Further, in the case of the illustrated example, the telephone line 5 is
Hospital transceiver device 6 installed at the hospital H where the attending physician is located
Is connected to the computer 7, the output side of which is connected to the computer 7. In the figure, 8 is a printer connected to the computer 7, and 9 is a sound or light alarm connected to the output side of the computer 7. ing.

Therefore, as is known, the home medical care patient inserts his / her finger into the sensor 1a of the pulse oximeter 1 described above at rest several times a day such as after eating in the morning, noon, and evening, and then SpO
₂ and pulse will be measured, but at this time the display unit 1b
When the numerical value displayed on is stable, relay box 2
When the transmission switch 2a is closed, the measurement pilot lamp 2b is turned on, the SpO ₂ value and pulse value for a specified number of seconds are recorded in the home transmitter / receiver 3, and when the specified number of seconds has elapsed, the measurement pilot lamp 2b is recorded. 2b is turned off to notify the subject that the measurement is completed, and the finger is removed from the sensor 1a to complete the measurement.

Next, the home transmitter / receiver 3 automatically turns the telephone number of the hospital H and transfers the measured value data to the computer 7 via the telephone transmitter / receiver 6 via the telephone line 5. Will be sent. At this time, the computer 7 is always installed in a nurse station or the like where there are people, and the computer 7 automatically analyzes the measured value data of the present invention described in detail below. , As mentioned above, Sp
If it is determined that there is a specific change in the O ₂ value and the pulse value, notify the attending physician or nurse of the change in the measured value data by visual inspection of the computer 7 itself or by an alarm of the warning device 9 shown in the figure. become.

In the case where the present invention is carried out as described above, the attending physician who actually confirms the alarm immediately asks the patient by telephone for the peculiar change in the measured value data. By doing so, the condition is grasped in detail, and if necessary, an emergency visit is instructed to perform a detailed examination at the hospital or an emergency hospitalization.

Of course, the present invention is not only implemented as described above, but a device having a data analysis function, such as a computer, is mounted on the front transmitter / receiver 3 for home use,
Only when it is determined by the data analysis that the measured value data has changed, the fact is transmitted to the hospital side, otherwise, for example, the measured value data is periodically transmitted to the hospital side once a week. The present invention may be put into practice under the embodiment of transmitting.

In such a case, an alarm is actually generated by the home-use transmitting / receiving device, and the patient is allowed to continuously measure the SpO ₂ value and the pulse value, and the sampling number is increased. It becomes possible to quickly determine whether the change in the measured value data is a temporary one such as an error in the oxygen inhalation amount or a measurement when not resting, and the accuracy of the determination by the automatic analysis according to the present invention. Can be improved.

Therefore, the method for determining the rapid decrease in the SpO ₂ value according to claim 1 will be described in detail below. For home-care patients who are undergoing home oxygen therapy, the average level and the variation thereof are different. since there are individual differences in, determine the lower limit value is a limit value of the SpO ₂ values ignore the individual differences, when the SpO ₂ measurement is below than this, there was a sharp drop in SpO ₂ Even if the judgment is made, the correct judgment result cannot be obtained.

In the present invention, taking the above points into consideration, the individual difference of the plainness is first expressed by the numerical values of the average and the deviation from the past measured value data. In addition, not only the average and the deviation are obtained as specified in the calculation formula in the first step for all the data of the SpO ₂ value of the previous month in a predetermined recent period that does not retroactively go up, for example, in the embodiment of FIG. From the mean and the deviation,
The second step is completed by obtaining the average ± Pa × deviation with Pa = 2 to 3 as a parameter.

Next, when all the SpO ₂ value data represented by YSi in FIG. 1 are all included in the above range of average ± Pa × deviation, the process shifts from the third step to the fifth step of the next description. However, if the SpO ₂ is not within the above range,
When the value data exists, the SpO ₂ outside the relevant block is excluded, and the correction average and the correction deviation of the SpO ₂ value are recalculated as in the fourth step in the same manner as before. To the second process, the correction average ± Pa × correction deviation is obtained, and the process moves from the third process to the fifth process. Then, such calculation of the correction average and the correction deviation is repeated until all the values are included in the above range in the third step.

As described above, the repeated steps of the second step-third step-fourth step-second step are adopted, and in the predetermined recent period which is the previous month, the abnormal SpO ₂ If the measured value data is not deleted, the average, which normally expresses the individual difference, fluctuates up and down undesirably, or the deviation increases, resulting in incorrect expression of the individual difference. This is to prevent it from happening, which can improve the reliability of the determination in the present invention.

Next, in the fifth step, the SpO ₂ lower limit value for the current month is set to Pb = 2 by the average or calibration mean, deviation or calibration deviation of all SpO ₂ value data obtained as described above.
The ~ 3 as a parameter, the average -Pb × deviation, determined by calibration average -Pb × correction deviation, one after another transmission SpO ₂ value of the determination date in month, gradually as compared with the lower limit of the above-mentioned,
When the transmitted SpO ₂ value falls below the lower limit, SpO ₂
It is determined that there is a sharp drop in the value, and in the case of FIG. 2, the alarm device 9 connected to the computer 7 notifies the abnormality.

Here, the predetermined recent period for calculating the average and the deviation as described above is selected in the month before the judgment date. The average and the deviation having individual differences throughout the year are the temperature and the like depending on the four seasons. It has been confirmed that its value is not constant but fluctuates due to the effects of illness, the progression of pathological conditions, the decrease of physical strength, etc., so the measurement data interval that most reflects the recent condition of home care patients. This is because the latest data calculation period is desirable. However, of course, it does not have to be limited to the previous month,
In general terms, it suffices to select a period that most reflects the normal condition of the patient.

Incidentally, as will be described later in detail as an embodiment, FIG. 3 shows all SpO ₂ value data according to claim 1, and FIG. 5 shows all pulse value values according to claim 2 of the following theory. 3 is a chart showing data, and Table 1 shows SpO ₂ corresponding to FIG.
In the list of all the value data, Table 2 shows a list of all the pulse value data corresponding to FIG.

Next, the method for determining a rapid rise in the pulse value according to claim 2 will be explained. The basic idea is the same as in the case of claim 1, and the details of the process are shown in FIG. Then, an example thereof is specified. That is, the previous month is selected as the predetermined recent period, the average and deviation of all pulse value data measured here are obtained, and within the range of the average ± Pc × deviation related to the pulse value with Pc = 2 to 3 as a parameter, When all of the above pulse value data are included, the pulse upper limit value is obtained by the average + Pd x deviation with Pd = 2 to 3 as a parameter, and there is pulse value data outside the range of the average ± Pc x deviation. In this case, this is excluded to obtain the calibration average and the calibration deviation of the pulse value data, and the pulse upper limit calibration average + Pd × calibration deviation based on this is calculated. Thereby, the first, second, and third steps of FIG. 4 are transferred to the fifth step,
1st, 2nd, 3rd, 4th steps and then 2nd, 3rd
The fifth step is reached through the steps. Of course, similarly to claim 1, the calculation of the calibration mean and the calibration deviation is repeated until there is no pulse value data outside the above range.

Then, in the sixth step, the pulse upper limit value thus obtained is compared with the transmitted pulse value input to the computer 7 after a predetermined recent time period. By detecting that the transmission pulse rate exceeds the above pulse upper limit value, it is determined that a sudden rise in the pulse value of the home care patient.

Further, the method for judging the gradual decrease of the SpO ₂ value according to the third aspect will be explained. What is important here is to roughly judge as shown in FIG. 6 as an embodiment thereof. The calculation procedure of the mean and the deviation used in the above, the calculation procedure of the linear approximation formula by the least square method, and the determination procedure using the former procedure result and the latter procedure result. And the important point is
Even in this determination, since it is not possible to perform the determination in the same manner as above, ignoring the fact that there are individual differences, it is possible to simply use SpO ₂
Without using only the slope of all the value data in the linear approximation as the criterion for judgment, the individual difference of the plainness is expressed by the average and deviation of all the recent SpO ₂ value data, and further, it is the minimum two for the transmitted SpO ₂ value. The linear approximation is performed by the multiplication method, and the average and deviation and the Y-intercept and the slope according to the linear approximation formula are used to obtain SpO.
The presence or absence of moderate descent of _binary is that you are trying to determine with high accuracy.

Therefore, what is important in claim 3 is that, as clearly shown in FIG. 6, a predetermined near-term period P ₁ (see FIG. 7) for calculating an average and a deviation expressing individual differences, and The predetermined immediately preceding period P ₂ (see FIG. 7) for linear approximation is divided into independent periods that do not overlap each other. That is, in the example shown in the first step of FIG. 6, 14 days from 8 days before to 21 days before including the determination date for the change in the SpO ₂ value is set as the predetermined near-previous period P ₁ as shown in FIG. While selecting and obtaining the average and deviation of all SpO ₂ value data at P ₁ ,
A predetermined immediately preceding period P ₂ for obtaining the Y intercept A and the slope B shown in FIG. 7 of the linear approximation formula shown as the sixth step of FIG.
As the origin of the time axis, 7 days before the determination date, with respect to all SpO ₂ value data at P ₂ ,
The Y-intercept A and the slope B are obtained as described above by the least-squares method.

In this way, the predetermined near-previous period P ₁ and the predetermined immediately preceding period P ₂ are separated from each other. The reason is that the measured value data in the period part in which the individual difference in the normal time is linearly approximated is calculated. In order to prevent the influence of the above, specifically, when the measured value data for linear approximation shows a downward or upward trend, the period for linear approximation is selected for the calculation of the above individual difference. This is because if included in the period, the above-mentioned average level rises and falls and the deviation increases, and it becomes impossible to calculate the correct individual difference in normal times.

Now, if the average and the deviation are obtained in the first step in FIG. 6 as described above, in claim 3, in the second step, as described in claim 1 above, The average ± Pe × deviation is obtained from the average and the deviation of the above with Pe = 2 to 3 as parameters. And
Further, as understood from the third, fourth, and fifth steps, all SpO ₂ value data in the first step is included in the range of the above-mentioned mean ± Pe × deviation, as in the case of claim 1. Then, as shown in the fifth step, the average and the deviation are
It will be adopted in the subsequent 10th step. On the other hand, when there is SpO ₂ value data that is not included in the above average ± Pe × deviation, the correction average and the correction deviation are calculated by excluding this, and the results are used in the 10th step as described later. It will be.

On the other hand, regarding the calculation of the above-mentioned linear approximation formula, as clearly shown as the sixth step of FIG. 6 and understood from FIG. 7, the Y-intercept is obtained by the least-squares method based on all the SpO ₂ value data in the predetermined immediately preceding period P ₂ . A and the slope B are obtained, and if the slope B is positive, it is judged in the ninth step that there is no gentle downward tendency of the SpO ₂ value, and if it is detected that the slope B is negative, For the slope B in the process, a test of significance is performed for the purpose of examining the contingency, and when 0 is included in the test reference range, it is regarded as not significant,
In the ninth step, it is determined that the SpO ₂ value has not fallen gently.

Here, the above-mentioned significance test may be carried out by a known means. If this is explained with reference to FIG. 8, the Sb value of the second procedure is obtained by the setting of the first procedure. , And the slope of the third procedure ± t
By checking whether 0 is included in the range of 0.05 × Sb, it is determined whether or not there is significance.

Next, in the tenth step shown in FIG.
The average −Pf × deviation with Pf = 2 to 3 as a parameter for determining the gradual decrease of the pO ₂ measurement value and the slope B × the number of days of the predetermined immediately preceding period P ₂ (7 days) + Y intercept A are compared to obtain the average. If the condition of −Pf × deviation> slope × predetermined number of days in the immediately preceding period + Y intercept is not satisfied, it is determined that there is no slow decrease in the SpO ₂ measurement value, and since the condition is satisfied, the above-described gentle decrease is achieved. It is determined that there is.

Incidentally, as will be described in detail in the section of Examples described later, FIG. 9 shows all SpO ₂ value data according to claim 3, and FIG. 11 shows the pulse according to claim 4 of the following theory. It is a chart showing all the value data, and Table 3 shows SpO corresponding to FIG.
₂ value list of all the data, a list of pulse values all data in Table 4 is also corresponding to FIG. 11.

Further, a method for judging a gradual increase in the pulse value according to claim 4 will be explained. The basic idea is similar to the relationship between claim 1 and claim 2, and the above-mentioned claim. This is similar to the case of the item 3, and the content thereof is shown in FIG. 10 as an example. That is, 14 days from 8 days before to 21 days before including the judgment day are selected as the predetermined recent period, and the average and deviation of all the pulse value data within this period are calculated. = Average of 2 to 3 as a parameter ± Pg x
Knowing the deviation completes the first and second steps.

Further, in the second, third, fourth and fifth steps, substantially the same method as in the case of claim 3 is carried out,
If all the above-mentioned pulse value data are included within the range of mean ± Pg × deviation, the average and deviation at that time are adopted as they are, and if there is all pulse value data outside the above range,
The calibration mean and calibration deviation calculated after excluding this will be used.

Further, as the procedure for calculating and determining the linear approximation formula, the 6th to 11th steps are adopted, and as in the case of FIG. 6, 7 days before the determination date is predetermined. As the immediately preceding period, the starting point is set as the origin of the time axis, the Y intercept and the slope are obtained by the least squares method with respect to all the pulse value data in this period. In this case, when the slope is negative, the pulse value is It is judged that there is no gradual increase tendency of No., and if the slope is positive, a significance test is performed on this, and if there is no significance, it is judged that there is no moderate increase as described above in the ninth step. To do.

In the above case, if the significance of the inclination is approved, as shown in the drawings as the 10th step and the 11th step, Ph
= 2 to 3 as a parameter, from the same idea as described in claim 3, if the condition of average + Ph x deviation <slope + number of days of a predetermined immediately preceding period + Y intercept is not satisfied, the gradual increase in pulse value will not occur. Without
If the condition is satisfied, it is determined that the pulse value is gradually increasing.

Here, the selection of the predetermined near-term period and the predetermined immediately preceding period is not limited to the illustrated example in both claim 3 and claim 4, and the former is a normal home-care patient. Therefore, it suffices to select a period that reflects the condition, and even in the latter case, it is desirable that the number of measured value data for linear approximation is 10 or more, so if this condition can always be satisfied. If so, 7
It may not be longer than a day and may be shorter than that.

[0041]

EXAMPLES In order to deepen the understanding of the determination method according to the present invention, the analysis of the measured value data will be explained below with reference to each of claims 1 to 4. First, in claim 1, a sudden drop in the SpO ₂ value is judged, but referring to FIG. 2 and Table 1 below, SpO in February
₂ To calculate the lower limit, the average and deviation of all SpO ₂ value data (No. 1 to No. 91 in Table 1) during January are calculated from the calculation formula based on the first step in FIG. An average of 92.8% and a deviation of 1.86% could be calculated.

[Table 1]

Here, all the SpO ₂ value data (No. 1 to No. 91) used for the above calculation is 92.8% ± 3.
When it is examined whether it is included in the range of × 1.86%, No. 10, No. 67, and No. Since the measured value data of 77 was not included in the range,
All the remaining SpO ₂ excluding the above measured value data
When the average and the deviation of the measured data were separately obtained, an average of 93.0% and a deviation of 1.50% could be calculated.

Therefore, the No. 10, No. 67, N
o. No. excluding 77. 1 to No. As a result of checking whether the measured value data of 91 is included in the range of 93.0% ± 3 × 1.50%, none of the measured values is out of the range. As a result, the lower limit value of SpO ₂ in _{February was obtained.} As a result, 93.0% −3 × 1.50% = 88.5% could be specified. When the above SpO ₂ lower limit value and the transmitted SpO ₂ value in _February were compared and it was checked whether or not there was any value lower than the above lower limit value on February 24 in Table 1 ( No. 160), February 25 (No. 163) and February 26 (No.
167), the alarm 9 of FIG. 2 reported the alarm. In such a case, the attending physician needs to give appropriate instructions to the patient, and measures such as admission to the hospital will be taken.

Next, a concrete example of the case of determining a rapid rise of the pulse value according to claim 2 will be described with reference to FIG. 5 and Table 2 below. First, all the pulse value data (No.
No. 104), the average and deviation were obtained in the first step of FIG. 6 to obtain an average of 74.1% and a deviation of 6.38%, and all the pulse value data used for the calculation were 74.1%.
% ± 3 × 6.38% (Pe = 3), it was examined whether or not it was included in the range. Since No. 12 of 94.0 is out of the range, No. 1 to No. 1
By recalculating the data of 04, the correction average and the correction deviation were obtained, and the correction average was 73.9% and the correction deviation was 6.09%.

[Table 2]

Then, again, 73.9% ± 3 × 6.09%
In the range of No. No. 12 except 1 to No. 104
It was confirmed whether or not the pulse value data of was included, and it was confirmed that it was included.
3.9% + 3 × 6.09% = 92.2% was obtained. As a result of performing the eleventh step of FIG. 6 with this upper limit value, as shown in Table 2, October 7 (No. 129), October 27 (N
o. 195) October 28 (No. 198) October 29 (No. 201) October 31 (No. 20)
The alarm device 9 was activated in 8), and it was determined that there was a sharp rise in the pulse value.

Next, a concrete example of the method for judging that the SpO ₂ value has a gradual downward tendency according to claim 3 will be described in detail below with reference to FIGS. 6 and 9 and Table 3 below. To do. No. on May 10 in Table 3 When the SpO ₂ value sent by S.58 is input to the computer 7, the SpO of 8 days to 21 days before including May 10th, that is, the SpO of April 20th to May 3rd is first.
_When the average and deviation of all binary data (No. 1 to No. 39) are calculated, the average is 89.6% and the deviation is 1.01%. Here, all the measured value data (No. 1 to No. 39), 89.6% ± 3 × 1.
When it was examined whether or not it was included in the range of 01% (Pg = 3), it was found that all were included in the range, so it was decided to use the above average and deviation for determination in the tenth step.

[Table 3]

Next, until 7 days before May 10, that is, with respect to all SpO ₂ value data (No. 40 to No. 58) from May 4 to May 10, 4 If the measurement time is converted with the day of the day as the origin of the time axis and the unit is day, for example, No. Since the time to 45 measured value data is 1.825 days, the Y-intercept and the slope are calculated by the least-squares method, and the Y-intercept is 89.9% and the slope is −0.164. Therefore, since this slope is negative, the next 95% confidence interval for the slope is
The above Sb is Sb = 0.216, and the number of data NS = 19 (No. 40 to No. 5).
From 8), since the value of significance point = 0.05 of 19-2 t distribution is 2.110, the 95% confidence interval is −0.164 ± 2.110 × 0.216.

Therefore, the above section includes 0, and since it can be tested that there is no significance in the eighth step of FIG. 6, it is determined that the SpO ₂ value does not have a gradual downward tendency. When the transmission SpO ₂ value on May 10 (No. 60) is transmitted to the computer 7, the average is 89.6%, the deviation is 1.101%, the Y intercept is 90.6%, the slope is −0.474 95%. Confidence interval of −0.474 ± 2.093 ×
Since it is 0.222, and this section does not include 0, the success or failure of the inequality judgment formula was calculated based on the 10th process. 89.6% −2 × 1.101% = 87.4%> − 0.474 × 7 + 90.6%
= 87.3%, the SpO ₂ value was judged to have a gradual downward trend, and the alarm device 9 reported an alarm accordingly.

By the same procedure as above, No. 61-N
o. No. 66 is determined. 61, no. 62, N
o. 63, No. 64, and No. 66 are all S
When it is judged that the pO ₂ value is gradually decreasing, an alarm or the like is issued, and No. 65 means that the slope has no significance.

Finally, in the case of determining a gradual increase in pulse value, that is, in the specific example according to claim 4, FIG.
This is illustrated below with reference to FIG. 11 and Table 4 below.

[Table 4] Now, in Table 4 above, No. When 79 pulse value data was sent to the computer 7, first, 14 days from 8 days before including 21st July to 21 days before
The average and deviation of all the pulse value data (No. 1 to No. 55) from July 4th to July 17th are calculated for each day, and the average of 92.7% and the deviation of 3.83% are thereby obtained. Calculated and used the above No. 1 to No. 5
It is checked whether all the data of 5 are included in the range of 92.7% ± 3 × 3.83%. As a result, since all are included in the range, the above average and deviation are calculated. It will be used for the determination described later.

Next, until 7 days before July 24, that is, all pulse value data (N 18) from July 18 to July 24
o. 56-No. 79), the measurement time is converted with the unit of the day being 0:00 on July 18 as the origin of the time axis. Since the time until the data of 60 measured values is 1.222 days, the Y intercept and the slope are obtained by the least squares method, and the Y intercept 91.6% and the slope 0.288 are obtained. Therefore, since this inclination is positive, the following eighth step is performed by this, and the inclination is 95%.
When the confidence interval of% is obtained, Sb becomes Sb = 0.503, and the number of data NS24 (No. 56 to No. 79)
Therefore, the value of significance point = 0.05 of the t distribution of 24-2 is
Since it is 2.074, the 95% confidence interval is 0.288 ± 2.074 × 0.503, and since this interval includes 0, it can be tested that there is no significance, and thus the pulse value Is determined not to be a gradual rise.

Similarly, No. 80-N
o. 82, the input to the computer 7 is also insignificant, and therefore it is determined that no gradual increase in all pulse value data is observed. 83
, The mean is 92.8%, the deviation is 3.748%, the Y-intercept is 90.5%, the slope is 1.113, the 95% confidence interval is 1.113 ± 2.074 × 0.
Since it is 526, this section does not include 0 and is tested as significant, and the success or failure of the inequality discriminant is 92.8% + 2 x 3.748% = 100.3%> 1.113 x 7 + 90.5%.
= 98.3%, it can be determined that all the pulse value data do not have a moderate increase. 84 and No.
The determination of 85 is also significant, but it is determined that the increase is not moderate.

Furthermore, No. 7 of July 26. In the case of 86, the average is 92.9%, the deviation is 3.834%, the Y-intercept is 90.1%, the slope is 1.635, the 95% confidence interval is 1.635 ± 2.080 × 0.
It becomes 504, and this section is significant because it does not include 0, so it is 92.9% + 2 × 3.834% = 100.6% <1.635 × 7 + 90.1% by the inequality judgment formula for judgment.
= 101.5%, it is judged that there is a gradual rise in the pulse value and the alarm is sounded. Similarly, No. 87 and N
o. The determination result of No. 88 is No. 88 above. 8
As with No. 6, an alarm was issued.

[0054]

Since the present invention can be carried out as described above, the measurement of the SpO ₂ value and the pulse value, which are periodically transmitted, for the home care patients receiving home oxygen therapy. Not only can the condition of the patient be grasped by examining the value data, but the SpO ₂ value in claim 1 is sharply decreased and the pulse value is rapidly increased in claim 2 for the measured data by a computer. Claim 3
Then, with respect to the gradual decrease of the SpO ₂ value, and in claim 4, with respect to the gradual increase of the pulse value, by automatic analysis,
Since it is possible to make judgments with high reliability, an analysis-dedicated operator is not required, and the problems of superiority and inferiority of artificial analysis means and erroneous operation can be solved, and moreover, anyone can promptly recognize a change in measured value data with an alarm etc. Will get
Same as above, the emergency response to the patient is accelerated.

[Brief description of drawings]

FIG. 1 is a flow chart showing an example of a method according to claim 1 for determining a sudden decrease in SpO ₂ value of a home care patient.

FIG. 2 is a structural explanatory view showing an example of an apparatus for transmitting measured value data used for carrying out a determination method according to the present invention.

FIG. 3 is a trend graph showing each data of SpO ₂ value and pulse value according to claim 1 of the present application.

FIG. 4 is a flowchart showing an example of a method according to claim 2 for determining a rapid rise in a home care patient pulse value.

FIG. 5 is a trend graph showing each data of pulse value and SpO ₂ value according to claim 2 of the present application.

FIG. 6 is a flowchart showing a method example according to claim 3 for determining a gradual decrease of the home care patient SpO ₂ value.

FIG. 7 is an explanatory diagram for illustrating a significance test method of a slope obtained by calculating a linear approximation formula of SpO ₂ value data according to claim 3 of the present application.

FIG. 8 is a flow chart showing a procedure for testing the significance of the slope in claims 3 and 4 of the present application.

FIG. 9 is a trend graph showing each data of SpO ₂ value and pulse value according to claim 3 of the present application.

FIG. 10 is a flowchart showing an example of a method according to claim 4 for determining a gradual increase in the pulse value of a home care patient.

FIG. 11 is a trend graph showing each data of pulse value and SpO ₂ value according to claim 4 of the present application.

[Explanation of symbols]

1 Pulse oximeter 7 Computer A Y intercept B Slope P ₁ Predetermined near previous period P ₂ Predetermined immediately preceding period

Claims (4)

[Claims] 1. A home-care patient undergoing home oxygen therapy continuously transmits his or her arterial oxygen saturation (SpO ₂ value) measured by a pulse oximeter to a computer at a required location. With respect to the transmitted SpO ₂ value, the above computer calculates the average and deviation of all SpO ₂ value data in a predetermined recent period, and from these average and deviation, the average ± Pa × deviation with Pa = 2 to 3 as a parameter is calculated. If all of the above SpO ₂ value data are included within the range of this average ± Pa × deviation, the Pb for the predetermined near period is determined by the average and deviation.
= 2 to 3 is used as a parameter, the average value of the lower limit of SpO ₂ −Pb × deviation is obtained, and when all the data of the above SpO ₂ values include data that is not within the range of ± Pb × deviation, SpO ₂ until no more data
The calibration average and calibration deviation of the SpO ₂ value data excluding the values are calculated, and the calibration average −Pb ×, which is the lower limit value of SpO ₂ described above.
By calculating the calibration deviation and comparing the SpO ₂ lower limit value thus obtained with the transmission SpO ₂ value that is input to the computer after the predetermined recent period, the transmission SpO ₂ value is calculated. A patient condition due to a change in arterial oxygen saturation measured by detecting that the SpO ₂ value of the home-care patient has suddenly decreased by detecting that the SpO ₂ lower limit is exceeded. Judgment method by automatic analysis of. 2. A home care patient undergoing home oxygen therapy continuously transmits his / her own pulse value measured by a pulse oximeter to a computer at a required location, and the transmission pulse value is set as described above. The average and deviation of all pulse value data in a predetermined recent period are obtained by a computer, and the average ± Pc × deviation with Pc = 2 to 3 as a parameter is obtained from these average and deviation, and this average ± Pc × deviation If all of the above pulse value data are included in the range, the average + Pd x deviation, which is the pulse upper limit value with Pd = 2 to 3 as the parameter, is calculated from the average and deviation. When all the pulse value data include data that is not within the range of mean ± Pc × deviation, the pulse value data excluding the pulse value is excluded until the data is not included. The calibration average and the calibration deviation are obtained, and the calibration average + Pd × calibration deviation, which is the pulse upper limit value, is calculated, and the pulse upper limit value thus obtained and the predetermined upper limit value are input to the computer after the predetermined recent period. By comparing the transmitted transmission pulse values, by detecting that the transmission pulse value exceeds the above pulse upper limit value, it is possible to determine that the pulse value of the home care patient has suddenly increased. A determination method by automatic analysis of a patient's condition based on changes in pulse measurement values. 3. A home-care patient undergoing home oxygen therapy continuously transmits his or her own arterial oxygen saturation (SpO ₂ value) measured by a pulse oximeter to a computer at a required location, With respect to the transmitted SpO ₂ value, the above computer calculates the average and deviation of all SpO ₂ value data in a predetermined recent period, and from these average and deviation, the average ± Pe × deviation with Pe = 2 to 3 as a parameter. If all of the above SpO ₂ value data are included in the range of this average ± Pe × deviation, the average and deviation are adopted at the time of the determination described below, and the S
If all the pO ₂ value data include data that is not within the range of ± Pe × deviation, the correct average and correction deviation of SpO ₂ value data excluding the SpO ₂ value are excluded until the data is no longer included. Then, the correction average and the correction deviation are adopted at the time of the determination to be described later.On the other hand, the start of the predetermined immediately preceding period after the predetermined recent period before the determination date is set as the origin of the time axis, and For all SpO ₂ values over the immediately preceding period, the Y-intercept and the slope are obtained by the method of least squares. If this slope is positive, it is determined that the SpO ₂ value has no gradual downward trend, and the above slope is negative. Tests the significance of the slope, judges that there is no gradual downward trend in the SpO ₂ value when the result is not significant, and when the above result is significant, Average or change Positive mean and deviation or calibration deviation and Y-intercept and slope are adopted, and with Pf = 2 to 3 as a parameter, average or calibration mean-Pf x deviation or calibration deviation> slope x number of days in the immediately preceding predetermined period + Y-intercept When the equality determination formula is not established, it is determined that the SpO ₂ value does not have a gradual downward trend, and when the inequality determination formula is satisfied, it is determined that the SpO ₂ value is gradually decreasing. A determination method by automatic analysis of a patient's condition based on changes in arterial blood oxygen saturation measurement values. 4. A home care patient undergoing home oxygen therapy continuously transmits his / her own pulse value measured by a pulse oximeter to a computer at a required location, and the above-mentioned transmitted pulse value is used for the above-mentioned pulse value. The computer calculates the average and deviation of all the pulse value data in the predetermined recent period, and Pg = 2 to 2 from these averages and deviations.
Average ± Pg x deviation with 3 as a parameter is obtained, and within the range of this average ± Pg x deviation, all the above pulse value data are
If all of them are included, the average and deviation are adopted at the time of the determination described later, and if all the pulse value data include data that is not within the range of ± Pg × deviation, the data is not included. , The calibration average and the calibration deviation of the pulse value data excluding the pulse value are obtained, and the calibration average and the calibration deviation are adopted at the time of the determination to be described later, while the determination is made after the predetermined recent previous period. Taking the start point of the predetermined immediately preceding period before the day as the origin of the time axis, the Y-intercept and the slope are obtained by the least-squares method for all pulse values over the predetermined immediately preceding period, and if the slope is negative, the pulse value is gentle. If it is determined that there is no rising tendency, and if the above-mentioned slope is positive, the significance of the slope is tested, and if the result is not significant, it is determined that there is no gentle rising tendency in the pulse value. , The above When the result is significant, the above-mentioned mean or calibration mean and deviation or calibration mean and Y intercept and slope are adopted, and with Ph = 2 to 3 as parameters, the mean or calibration mean + Ph × deviation or calibration Deviation <Slope x Number of days in the immediately preceding predetermined period + If the inequality determination formula for the Y-intercept is not established, it is determined that there is no gentle upward trend in the pulse value, and if the inequality determination formula is established, the pulse value is moderate. Determination method by automatic analysis of a patient's condition due to a change in pulse value, which is characterized in that it is determined to be in a rise.