DETECTION OF DRASTIC BLOOD PRESSURE CHANGES

• US 20090082684A1
• Filed: 09/12/2005
• Published: 03/26/2009
• Est. Priority Date: 09/13/2004
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Sornmo, Leif, Solem, Kristian
• Granted Patent: US 8,060,190 B2
• Time in Patent Office: Days
• US Class Current: 600/513
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation

Abstract

The invention relates to cardiac-activity based prediction of a rapid drop in a patient'"'"'s blood pressure during hemodialysis. A proposed alarm apparatus includes an input interface, primary and secondary analysis units and an alarm-generating unit. An electrocardiogram signal (H_ECG) of the patient is received via the input interface by the primary analysis unit, which in response thereto produces a heart-rate-variability signal (P_HRV). The secondary analysis unit determines an intensity of ectopic beats (P_EBC) based on the electrocardiogram signal (H_ECG). The alarm-generating unit investigates whether the intensity of ectopic beats (P_EBC) is relatively low or relatively high. In case of a relatively low intensity, the unit triggers an alarm signal (α) indicative of an estimated rapid blood pressure decrease if the heart-rate-variability signal (P_HRV) fulfills a first alarm criterion. In case of a relatively high intensity, however, the unit triggers the alarm signal (α) if the intensity of the ectopic beats (P_EBC) fulfills a second alarm criterion.

Claims

1. An alarm apparatus for predicting a rapid blood pressure decrease in a patient undergoing hemodialysis treatment, comprising:

an input interface adapted to receive an electrocardiogram signal (H_ECG) of the patient;

a primary analysis unit (130) adapted to produce a heart-rate-variability signal (p_HRV) based on the electrocardiogram signal (H_ECG);

a secondary analysis unit adapted to determine an intensity of ectopic beats (p_EBC) based on the electrocardiogram signal (H_ECG);

an alarm generating unit adapted to investigate whether the intensity of ectopic beats (p_EBC) is relatively low or relatively high, said alarm generating unit being configured to trigger an alarm signal (∀

) indicative of an estimated rapid blood pressure decrease if the heart-rate-variability signal (p_HRV) fulfills a first alarm criterion, when said intensity of ectopic beats is relatively low, and said alarm generating unit being further configured to trigger said alarm signal (∀

) indicative of an estimated rapid blood pressure increase if the heartrate variability signal (p_HRV) fulfills a second alarm criterion, when said intensity of ectopic beats is relatively high.

2. The alarm apparatus according to claim 1, wherein the primary analysis unit comprises a spectral analysis module adapted to produce the heart-rate-variability signal (p_HRV) by:

transforming a heart rate signal (H_R) based on the electrocardiogram signal (H_ECG) into a power spectrum representation of the electrocardiogram signal (H_ECG); and

calculating a ratio (p_HRV) between a low-frequency band and a high-frequency band of said power spectrum representation, wherein said first alarm criterion is fulfilled if the ratio (p_HRV) is below a first threshold value.

3. The alarm apparatus according to claim 2, wherein the low-frequency band ranges from approximately 0.04 Hertz to approximately 0.15 Hertz, the high-frequency band ranges from approximately 0.15 Hertz to approximately 0.04 Hertz, and the first threshold value is approximately equal to one.

4. The alarm apparatus according to claim 1, wherein the alarm apparatus comprises a beat morphology analysis unit adapted to:

receive the electrocardiogram signal (H_ECG), said electrocardiogram signal having multiple segments;

pre-process the electrocardiogram signal (H_ECG), the pre-processing involving classifying each segment of the electrocardiogram signal (H_ECG) to represent a particular type of event; and

producing an enhanced electrocardiogram signal (ECG_CL) equivalent to the electrocardiogram signal (H_ECG) wherein each signal segment is associated with relevant event-type data.

5. The alarm apparatus according to claim 4, wherein said event-type data comprises:

a normal beat representing a beat having a morphology typical for a patient; and

an ectopic beat representing a beat having a morphology non-typical for the patient.

6. The alarm apparatus according to claim 5, wherein said event-type data further comprises at least one of:

an artifact representing a beat that neither fulfills the criteria for a normal beat nor an ectopic beat; and

noise representing undesired energy of the electrocardiogram signal (H_ECG).

7. The alarm apparatus according to claim 4 or 5, wherein the primary analysis unit comprises a rate detector module adapted to receive the enhanced electrocardiogram signal (ECG_CL), and configured to produce a heart rate signal (H_R) based on said enhanced electrocardiogram signal (ECG_CL).

8. The alarm apparatus according to one of claims 45 or 6, wherein the secondary analysis unit is configured to determine the intensity of ectopic beats (p_EBC) based on the enhanced electrocardiogram signal (ECG_CL).

9. The alarm apparatus according to claim 1, wherein the second alarm criterion is fulfilled if the intensity of ectopic beats (P_EBC) exceeds a second threshold value.

10. The alarm apparatus according to claim 9, wherein the second threshold value represents a number equivalent to approximately four times a mean intensity of ectopic beats.

11. The alarm apparatus according to claim 1, wherein the apparatus comprises a third analysis unit configured to determine at least one heart-rate-turbulence parameter (p_HRT) based on the electrocardiogram signal (H_ECG);

and the alarm generating unit is further configured, in case of a relatively high intensity of ectopic beats (p_EBC), to trigger the alarm signal (∀

) if the at least one heart-rate-turbulence parameter (P_HRT) fulfils at least one third alarm criterion.

12. The alarm apparatus according to claim 11, wherein the at least one heart-rate-turbulence parameter (p_HRT) comprises at least one of:

a first parameter (TO) expressing a turbulence-onset measure reflecting a relative change in the RR-intervals of the electrocardiogram signal (H_ECG); and

a second parameter (TS) expressing a turbulence-slope measure reflecting a rise rate of the RR-intervals during a period following a particular ectopic beat.

13. The alarm apparatus according to claim 12, wherein one third alarm criterion is fulfilled if:

the first parameter (TO) exceeds a first turbulence threshold value;

or

the second parameter (TS) is outside an interval delimited by a lower second turbulence value and an upper second turbulence value.

14. The alarm apparatus according to claim 13, wherein the first parameter (TO) is determined as a difference between an average RR-interval shortly after (RR₁, RR₂) a particular ventricular ectopic beat and an average RR-interval shortly before (RR₋

2, RR<sub>−

1</sub>) the particular ventricular ectopic beat divided by the average RR-interval shortly before (RR<sub>−

2</sub>, RR<sub>−

1</sub>) said particular ventricular ectopic beat, said first turbulence threshold value representing a zero alteration of the RR-interval from shortly before to shortly after said ventricular ectopic beat.

15. The alarm apparatus according to claim 13 or 14, wherein the second parameter (TS) is determined based on a steepest slope found over a first set of RR-intervals within a second set of RR-intervals following immediately after said ventricular ectopic beat in a function expressing a time difference between consecutive R waves in the electrocardiogram signal (H_ECG);

and said lower second turbulence value represents one millisecond per RR-interval.

16. A medical system comprising a dialysis apparatus adapted to perform a hemodialysis treatment of a patient, wherein the system further comprises:

an electrocardiograph configured to register an electrocardiogram signal (H_ECG) of the patient;

an alarm apparatus according to claim 1 receiving said electrocardiogram signal (H_ECG); and

a dialysis control unit configured to receive the alarm (∀

) signal from the alarm apparatus, and based on the alarm signal (∀

), transmit a control signal to the dialysis apparatus said control signal being configured to cause an adjustment of at least one dialysis parameter in the dialysis apparatus such that an estimated risk that the patient enters a hypotension state is reduced.

17. The medical system according to claim 16, wherein the control signal is configured to effect an interruption of the dialysis treatment performed by the hemodialysis apparatus.

18. A method for predicting a rapid blood pressure decrease in a patient undergoing hemodialysis treatment, comprising the steps of:

registering an electrocardiogram signal (H_ECG) of the patient; and

producing a heart rate variability signal (p_HRV) based on the electrocardiogram signal (H_ECG), based on the substeps of;

determining an intensity of ectopic beats (p_EBC) based on the electrocardiogram signal (H_ECG); and

investigating whether the intensity of ectopic beats (p_EBC) for a current period is relatively high or relatively low;

during periods of relatively low ectopic beat intensity (P_EBC);

triggering an alarm signal (∀

) indicative of an estimated rapid blood pressure decrease if the heart-rate-variability signal (p_HRV) fulfills a first alarm criterion, and during periods of relatively high ectopic beat intensity (p_EBC);

triggering said alarm signal (∀

) if the intensity of ectopic beats (p_EBC) fulfils a second alarm criterion.

19. The method according to claim 18, wherein at least during periods of relatively low ectopic beat intensity (p_EBC):

transforming an enhanced electrocardiogram signal (ECG_CL) based on the electrocardiogram signal (H_ECG) into a power spectrum representation;

calculating a ratio between a low-frequency band and a high-frequency band of said power spectrum to represent the heart-rate-variability signal (P_HRV); and

regarding the first alarm criterion as fulfilled if the ratio is below a first threshold value.

20. The method according to claim 19, wherein the low-frequency band ranging from approximately 0.04 Hertz to approximately 0.15 Hertz, the high-frequency band ranging from approximately 0.15 Hertz to approximately 0.04 Hertz, and the first threshold value being approximately equal to one.

21. The method according to claim 19 or 20, wherein the second alarm criterion is regarded as fulfilled if the intensity of ectopic beats (P_EBC) exceeds a second threshold value, said second threshold value representing a number equivalent to approximately four times a mean intensity of the ectopic beats.

22. The method according to claim 21, wherein the mean intensity of ectopic beats is calculated in a sliding window over the enhanced electrocardiogram signal (ECG_CL).

23. The method according to claim 19, wherein any detected ectopic beat is excluded from the enhanced electrocardiogram signal (ECG_CL) before calculating said ratio.

24. The method according to claim 23, wherein said excluding of ectopic beats includes excluding each non-ectopic beat following an ectopic beat.

25. The method according to claim 18, further comprising the steps of:

determining at least one heart-rate-turbulence parameter (P_HRT) based on the electrocardiogram signal (H_ECG), and during periods of relatively high ectopic beat intensity (P_EBC);

triggering the alarm signal (∀

) if the at least one heart-rate-turbulence parameter (P_HRT) fulfils at least one third alarm criterion.

26. The method according to claim 25, wherein the at least one heart-rate-turbulence parameter (P_HRT) comprises at least one of:

a first parameter (TO) expressing a turbulence-onset measure reflecting a relative change in the RR-intervals of the electrocardiogram signal (H_ECG); and

a second parameter (TS) expressing a turbulence-slope measure reflecting a rise rate of the RR-intervals during a period following a particular ventricular ectopic beat.

27. The method according to claim 26, wherein the at least one third alarm criterion is fulfilled if:

the first parameter (TO) exceeds a first turbulence threshold value;

or

the second parameter (TS) is outside an interval delimited by a lower second turbulence value and an upper second turbulence value.

28. The method according to claim 27, further comprising the step of:

determining the first parameter (TO) as a difference between an average RR-interval shortly after (RR₁, RR₂) a particular ventricular ectopic beat and an average RR-interval shortly before (RR<sub>−

2</sub>, RR<sub>−

1</sub>) the particular ventricular ectopic beat divided by the average RR-interval shortly before (RR<sub>−

2</sub>, RR<sub>−

1</sub>) said particular ventricular ectopic beat, said first turbulence threshold value representing a zero alteration of the RR-interval from shortly before to shortly after said ventricular ectopic beat.

29. The method according to claim 27 or 28, further comprising the step of:

determining the second parameter (TS) based on a steepest slope found over a first set of RR-intervals within a second set of RR-intervals following immediately after said ventricular ectopic beat in a function expressing a time difference between consecutive R waves in the electrocardiogram signal (H_ECG), said lower second turbulence value representing one millisecond per RR-interval.

30. A computer program directly loadable into the internal memory of a computer, said program comprising software for controlling the steps of claim 18 when said program is run on the computer.

31. A computer readable medium, having a program recorded thereon, said program being configured to make a computer control the steps of claim 18.