Detection of Drastic Blood Pressure Changes

• US 20080319332A1
• Filed: 08/10/2006
• Published: 12/25/2008
• Est. Priority Date: 09/12/2005
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Solem, Kristian, Sornmo, Leif
• Granted Patent: US 8,311,619 B2
• Time in Patent Office: Days
• US Class Current: 600/513
• CPC Class Codes: A61B 5/33 specially adapted for cooperation with other devices
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

The invention relates to cardiac-activity based prediction of a rapid drop in a patient'"'"'s blood pressure during extracorporeal blood treatment. A proposed alarm apparatus (100) includes a primary beat morphology analysis unit (120), a bank of secondary analysis units (B2) and an alarm generating unit (158). The primary beat morphology analysis unit (120) discriminates heart beats in a received basic electrocardiogram signal (H_ECG), classifies each beat into one out of at least two different beat categories, and associates each segment of the signal (H_ECG) with relevant event-type data. The event-type data and the basic electrocardiogram signal (H_ECG) together form an enhanced electrocardiogram signal (ECG_CL), based upon which the primary beat morphology analysis unit (120) determines whether one or more secondary signal analyses should be performed. Depending on the enhanced electrocardiogram signal'"'"'s (ECG_CL) properties, the bank of secondary analysis units (B2) performs none, one or more of up to at least two different types of secondary analyses, and for each analysis performed produces a respective test signal (P_HRV, P_EBC, P_HRT)—The alarm generating unit (158) receives the test signals (P_HRV, P_EBC, P_HRT), and triggers an alarm signal (α) indicative of an estimated rapid blood pressure decrease, if at least one alarm criterion is fulfilled.

Claims

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

an input interface configured to receive a basic electrocardiogram signal (H_ECG) of the patient, and

at least one analysis unit configured to produce at least one processed signal (ECG_CL, p_HRV, p_EBC, p_HRT) on the basis of the basic electrocardiogram signal (H_ECG), said basic electrocardiogram signal (H_ECG) having a plurality of signal segments, wherein the apparatus comprises;

a primary beat morphology analysis unit configured to;

discriminate heartbeats in the basic electrocardiogram signal (H_ECG),

classify each discriminated heartbeat into one out of at least two different beat categories,

associate each of the plurality of signal segments of the basic electrocardiogram signal (H_ECG) with event-type data reflecting a beat category represented by the signal during that segment, the event-type data and the basic electrocardiogram signal (H_ECG) together forming an enhanced electrocardiogram signal (ECG_CL), and

determine a number of secondary signal analyses to be performed in respect of the basic electrocardiogram signal (H_ECG);

a bank of secondary analysis units (B2) configured to receive and use the enhanced electrocardiogram signal (ECG_CL) to perform up to at least two different types of secondary analyses in response to control instructions (c₁, c₂, c₃) from the primary beat morphology analysis unit, and for each analysis performed to produce a respective test signal (p_HRV, p_EBC, p_HRT); and

an alarm generating unit configured to receive the test signals (p_HRV, p_EBC, p_HRT), investigate whether any of the test signals (p_HRV, p_EBC, p_HRT) fulfill at least one alarm criterion, and if so, trigger an alarm signal (α

) indicative of an estimated rapid blood pressure decrease.

2. An alarm apparatus according to claim 1, wherein the bank of secondary analysis units (B2) comprises at least two different secondary analysis units selected from a group of:

a heart-rate-variability analysis unit configured to produce a first test signal (p_HRV) describing a ratio between a low-frequency band and a high-frequency band of a power spectrum representation of the basic electrocardiogram signal (H_ECG),

an ectopic-beat count unit configured to produce a second test signal (p_EBC) describing an intensity of ectopic beats, and

a heart-rate-turbulence analysis unit configured to produce at least one third test signal (p_HRT) describing at least one heart-rate-turbulence parameter.

3. An alarm apparatus according to claim 2, wherein the alarm generating unit is configured to trigger the alarm signal (α

);

if the first test signal (p_HRV) fulfills a first alarm criterion, or

if the second test signal (p_EBC) fulfils a second alarm criterion, or

if the at least one third test signal (p_HRT) fulfils at least one third alarm criterion.

4. An alarm apparatus according to claim 3, wherein the first alarm criterion is fulfilled if the first test signal (p_HRV) is below a first threshold value, and the second alarm criterion is fulfilled if the second test signal (p_EBC) exceeds a second threshold value.

5. An alarm apparatus according to claim 4, wherein the second threshold value represents a number equivalent to approximately four times a mean intensity of ectopic beats.

6. An alarm apparatus according to claim 3, wherein the at least one third test signal (p_HRT) comprises at least one of:

a first parameter (TO) expressing a turbulence-onset measure reflecting a relative change in RR-intervals of the basic electrocardiogram signal (H_ECG) during a period following a particular ectopic beat,

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, and

a pair of third quantities (SD₁, SD₂) expressing geometric properties of a Poincaré

plot in respect of the RR-intervals of the basic electrocardiogram signal (H_ECG) during a period following a particular ectopic beat.

7. An alarm apparatus according to claim 6, wherein the at least one third alarm criterion is fulfilled if:

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

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

the pair of third quantities (SD₁, SD₂) is estimated to represent an RR-interval variation below a third threshold value.

8. An alarm apparatus according to claim 7, 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>) this beat divided by the average RR-interval shortly before (RR<sub>−

2</sub>, RR<sub>−

1</sub>) said beat,

and the first turbulence threshold value represents a zero alteration of the RR-interval between shortly before to shortly after said ventricular ectopic beat.

9. An alarm apparatus according to claim 7, 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 basic electrocardiogram signal (H_ECG), and

the lower second turbulence value represents one millisecond per PR-interval.

10. An alarm apparatus according to claim 7, wherein the RR-interval variation is estimated to be below the third threshold value if, in the pair of third quantities (SD₁, SD₂):

a product between a first quantity (SD₁) and a second quantity (SD₂) falls below a threshold area estimate,

at least one of the first and second quantities (SD₁, SD₂) falls below a predetermined limit value, or

a ratio between the first quantity (SD₁) and the second quantity (SD₂) falls outside a predetermined interval.

11. An alarm apparatus according to claim 2, wherein the heart-rate-variability analysis unit comprises a spectral analysis module configured to produce the first test signal (p_HRV) by:

transforming a heart rate signal (R_H) based on the enhanced electrocardiogram signal (ECG_CL) into a power spectrum representation of the basic electrocardiogram signal (H_ECG), and

calculating the ratio (p_HRV) between the low-frequency band and the high-frequency band of said power spectrum representation.

12. An alarm apparatus according to claim 11, 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 0.40 Hertz, and the first threshold value is approximately equal to one.

13. An alarm apparatus according to claim 11, wherein the heart-rate-variability analysis unit comprises a rate detector module configured to receive and use the enhanced electrocardiogram signal (ECG_CL) to produce the heart rate signal (R_H).

14. An alarm apparatus according to claim 1, wherein said event-type data comprises a normal beat representing a beat whose morphology is typical for the patient, and at least one of the beat categories from a group including:

a ventricular ectopic beat representing a beat whose morphology differs substantially from a normal sinus beat,

a supraventricular ectopic beat representing a beat whose morphology differs from a normal sinus beat with respect to a P-wave morphology, and

a prolonged RR-interval representing a morphology wherein a time distance between two consecutive beats exceeds a typical time distance between two such beats for the patient by a predetermined proportion.

15. An alarm apparatus according to claim 14, wherein said event-type data further comprises at least one of:

an artifact representing a beat which fulfills none of the criteria for a normal beat, a ventricular ectopic beat, a supraventricular ectopic beat, and a prolonged RR-interval, and

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

16. A medical system comprising an apparatus configured to perform an extracorporeal blood treatment of a patient (P), wherein the system comprises:

an electrocardiograph configured to register a basic electrocardiogram signal (H_ECG) of the patient (P),

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

a treatment control unit configured to receive the alarm (α

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

), transmit a control signal (C) to the extracorporeal blood treatment apparatus, the control signal (C) being configured to cause an adjustment of at least one treatment parameter in the extracorporeal blood treatment apparatus such that an estimated risk that the patient (P) enters a hypotension state is reduced.

17. A medical system according to claim 16, characterized in that the control signal (C) is configured to effect an interruption of the treatment performed by the extracorporeal blood apparatus.

18. A method for predicting a rapid blood pressure decrease in a patient undergoing extracorporeal blood treatment, involving:

receiving a basic electrocardiogram signal (H_ECG) of the patient, and

producing at least one processed signal (ECG_CL, p_HRV, p_EBC, p_HRT) on the basis of the basic electrocardiogram signal (H_ECG), said basic electrocardiogram signal (H_ECG), having a plurality of signal segments, characterized by;

discriminating heart beats in the basic electrocardiogram signal (H_ECG),

classifying each discriminated heart beat into one out of at least two different beat categories,

associating each of the plurality of signal segments of the basic electrocardiogram signal (H_ECG) with event-type data reflecting a beat category represented by the signal during a particular signal segment, the event-type data and the basic electrocardiogram signal (H_ECG) together forming an enhanced electrocardiogram signal (ECG_CL),

determining a number of secondary signal analyses to be performed in respect of the basic electrocardiogram signal (H_ECG),

performing, based on the enhanced electrocardiogram signal (ECG_CL), up to at least two different types of secondary analyses to produce a respective resulting test signal (p_HRV, p_EBC), and

investigating whether any of the test signals (p_HRV, p_EBC, p_HRT) fulfill at least one alarm criterion, and if so,

triggering an alarm signal (α

) indicative of an estimated rapid blood pressure decrease.

19. A method according to claim 18, wherein the secondary signal analyses comprising at least two different secondary analyses selected from a group including:

a heart-rate-variability analysis producing a first test signal (p_HRV) describing a ratio between a low-frequency band and a high-frequency band of a power spectrum representation of the basic electrocardiogram signal (H_ECG),

an ectopic-beat analysis producing a second test signal (p_EBC) describing an intensity of ectopic beats, and

a heart-rate-turbulence analysis producing at least one third test signal (p_HRT) describing at least one heart-rate-turbulence parameter.

20. A method according to claim 19, wherein the alarm signal (α

) is triggered;

if the first test signal (p_HRV) fulfills a first alarm criterion,

if the second test signal (p_EBC) fulfils a second alarm criterion, or

if the at least one third test signal (p_HRT) fulfils at least one third alarm criterion.

21. A method according to claim 20, wherein the first alarm criterion is fulfilled if the first test signal (p_HRV) is below a first threshold value, and the second alarm criterion is fulfilled if the second test signal (p_EBC) exceeds a second threshold value.

22. A method according to claim 21, wherein the second threshold value represents a number equivalent to approximately four times a mean intensity of ectopic beats.

23. A method according to any one of the claims 20 to 22, wherein the at least one third test signal (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 basic electrocardiogram signal (H_ECG) during a period following a particular ectopic beat,

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, and

a pair of third quantities (SD₁, SD₂) expressing geometric properties of a Poincaré

plot in respect of the RR-intervals of the basic electrocardiogram signal (H_ECG) during a period following a particular ectopic beat.

24. A method according to claim 23, wherein the at least one third alarm criterion being fulfilled if:

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

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

the pair of third quantities (SD₁, SD₂) is estimated to represent an RR-interval variation below a third threshold value.

25. A method according to claim 24, further comprising 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₋

2, RR<sub>−

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

2</sub>, RR<sub>−

1</sub>) said beat, and

the first turbulence threshold value represents a zero alteration of the RR-interval between shortly before to shortly after said ventricular ectopic beat.

26. A method according to claim 24, further comprising:

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 basic electrocardiogram signal (H_ECG), and

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

27. A method according to claim 24, wherein the RR-interval variation is estimated to be below the third threshold value if, in the pair of third quantities (SD₁, SD₂):

a product between a first quantity (SD₁) and a second quantity (SD₂) fails below a threshold area estimate,

at least one of the first and second quantities (SD₁, SD₂) falls below a predetermined limit value, or

a ratio between the first quantity (SD₁) and the second quantity (SD₂) falls outside a predetermined interval.

28. A method according to claim 19, wherein the heart-rate-variability analysis comprises a spectral analysis wherein the first test signal (p_HRV) is produced by:

transforming a heart rate signal (R_H) based on the enhanced electrocardiogram signal (ECG_CL) into a power spectrum representation of the basic electrocardiogram signal (H_ECG), and

calculating the ratio (p_HRV) between the low-frequency band and the high-frequency band of said power spectrum representation.

29. A method according to claim 28, 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 0.40 Hertz, and the first threshold value is approximately equal to one.

30. A method according to claim 18, wherein said event-type data comprises a normal beat representing a beat whose morphology is typical for the patient, and at least one of the beat categories from a group including:

a ventricular ectopic beat representing a beat whose morphology differs substantially from a normal sinus beat,

a supraventricular ectopic beat representing a beat whose morphology differs from a normal sinus beat with respect to a P-wave morphology, and

a prolonged RR-interval representing a morphology wherein a time distance between two consecutive beats exceeds a typical time distance between two such beats for the patient by a predetermined proportion.

31. A method according to claim 30, wherein said event-type data further comprises at least one of:

an artifact representing a beat which fulfills none of the criteria for a normal beat, a ventricular ectopic beat, a supraventricular ectopic beat, and a prolonged RR-interval, and

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

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

32. (canceled)