System for therapeutic management of hemodynamic state of patient

• US 5,103,828 A
• Filed: 11/28/1990
• Issued: 04/14/1992
• Est. Priority Date: 07/14/1988
• Status: Expired due to Fees

• Current Assignee: Cardiodynamics International Corporation (Fujifilm Holdings Corporation)
• Original Assignee: Cardiodynamics International Corporation (Fujifilm Holdings Corporation)
• Inventors: Sramek, Bohumir
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): NASSER, ROBERT L
• Application Number:
  US07/622,322
• Time in Patent Office: 503 Days
• Field of Search: 128/713, 128/734, 128/668, 128/693, 600/16, 600/17
• US Class Current: 600/481
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis

Abstract

A therapeutic system provides a clinician with an appropriate course of treatment for a patient whose cardiovascular system is operating outside the normal range of values for the left cardiac work index (LCWI) and the systemic vascular resistance index (SVRI). The left cardiac work index and the systemic vascular resistance index are calculated from the cardiac index (CI) and mean arterial blood pressure (MAP) and are displayed as relative values so that the clinician can readily determine which of the vascular parameters are outside the normal range. Preferably, the cardiac index and the other cardiac parameters are measured by an electrical bioimpedance monitor that provides continuous dynamic measurement of the parameters. The left cardiac work index and the systemic vascular resistance index are calculated by a personal computer that displays the calculated parameters in an easily discernible manner.

Claims

1. A method of achieving a preselected hemodynamic state in a subject mammal comprising the steps of:

(a) determining the subject'"'"'s mean arterial pressure (MAP);

(b) measuring the subject'"'"'s cardiac index (CI);

(C) determining the subject'"'"'s left cardiac work index (LCWI) utilizing the measured MAP and CI values according to the formula;

space="preserve" listing-type="equation">LCWI=(MAP-PAOP)×

CI×

K

wherein PAOP represents pulmonary artery occluded pressure and K is a constant;

(D) determining the subject'"'"'s systemic vascular resistance index utilizing the measured MAP and CI values according to the formula;

##EQU7## wherein SVRI represents the systemic vascular resistance index, CVP is central venous pressure and L is a constant;

(E) preselecting a desired hemodynamic state, defined by desired values for LCWI and SVRI;

(F) determining the percentage deviation of the subject'"'"'s determined values for LCWI above or below the desired value for LCWI;

(G) determining the percentage deviation of the subject'"'"'s determined values for SVRI above or below the desired value for SVRI;

(H) administering a therapeutic doses of pharmacologically active materials for altering the LCWI and SVRI values to achieve in the subject the preselected hemodynamic state.

2. A method of achieving a preselected hemodynamic state as in claim 1, wherein the subject is an adult human.

3. A method of achieving a preselected hemodynamic state as in claim 2, wherein the preselected hemodynamic state comprises a systemic vascular resistance index of approximately 2030 dyn.sec/cm⁵ m², and a left cardiac work index of approximately 4.35 kg.m/m².

4. A method as in claim 3, wherein the pharmacologically active material comprises a vasodilator if the systemic vascular resistance index is greater than about 2030 dyn.sec/cm⁵ m².

5. A method as in claim 3, wherein the pharmacologically active material comprises a vasoconstrictor if the systemic vascular resistance index is less than about 2030 dyn.sec/cm⁵ m².

6. A method of achieving a preselected hemodynamic state as in claim 1, wherein the patient is an adult human and the preselected hemodynamic state comprises a systemic vascular resistance index within the range of from about 1700 to about 2650 dyn.sec/cm⁵ m².

7. A method of achieving a preselected hemodynamic state as in claim 1, wherein the patient is an adult human and the preselected hemodynamic state comprises a left cardiac work index within the range of from about 3.3 to about 5.3 kg.m/m².

8. A method of achieving a preselected hemodynamic state as in claim 1, wherein the patient is a neonatal infant human and the preselected hemodynamic state comprises a systemic vascular resistance index within the range of from about 950 to about 1500 dyn.sec/cm⁵ m².

9. A method of achieving a preselected hemodynamic state as in claim 1, wherein the patient is a neonatal human infant and the preselected hemodynamic state comprises a left cardiac work index within the range of from about 2.5 to about 4.0 kg.m/m².

10. The method of claim 1, further comprising:

(i) measuring the subject'"'"'s acceleration index (ACI);

(ii) preselecting a desired inotropic state, consisting of a value of ACI;

(iii) determining the percentage deviation of the subject'"'"'s measured value for ACI from the preselected value of ACI;

(iv) subtracting the determined percentage deviation of ACI from the percentage deviation of LCWI determined in step (F) in order to give an indication of the percentage of hypervolemia or hypovolemia;

(v) administering a therapeutic dose of pharmacologically active material or an amount of fluid for bringing the percentage of hypervolemia or hypovolemia to achieve in the subject the preselected volemic state.

11. The method of claim 10, wherein the subject is an adult human and the preselected inotropic state comprises an ACI measurement within the range of from about 0.5/sec² to about 1.5/sec².

12. The method of claim 11, wherein the preselected inotropic state comprises an ACI measurement of about 1.0sec².

13. The method of claim 10, wherein the percentage deviation in ACI is substantially equal to the percentage deviation of LCWI and the one or more pharmacologically active materials for bringing the percentage deviation of LCWI to substantially zero administered in step (H) comprises a pharmacologically active material for affecting inotropic state.

14. The method of claim 13, wherein the pharmacologically active material for affecting inotropic state comprises a negative inotropic.

15. The method of claim 10, wherein the percentage deviation in ACI is substantially zero, and the one or more pharmacologically active materials for bringing the percentage deviation of LCWI to substantially zero administered in step (H) comprises a pharmacologically active material for affecting volemia.

16. The method of claim 15, wherein pharmacologically active material for affecting volemia comprises a diuretic agent.

17. The method of claim 10, wherein the percentage deviation of LCWI determined in step (F), the percentage deviation of SVRI determined in step (G), and the difference between the percentage deviation of ACI and the percentage deviation of LCWI determined in step (iv) are all larger than substantially zero, and wherein the pharmacologically active materials administered in step (H) comprise:

a pharmacologically active material for affecting inotropy;

a pharmacologically active material for affecting volemia; and

a pharmacologically active material for affecting vasoactivity.

18. The method of claim 1, wherein the percentage deviation in LCWI is substantially zero, and the one or more pharmacologically active materials administered in step (H) comprises a pharmacologically active material for affecting vasoactivity.

19. The method of claim 18, wherein the pharmacologically active material for affecting vasoactivity comprises a vasodilator or an ACI inhibitor.

20. The method of claim 1, wherein the values for PAOP and CVP are assumed to have their values for a normal supine resting adult.

21. A method of achieving a preselected hemodynamic state in a mammal, comprising the steps of:

determining means arterial pressure in the mammal;

measuring cardiac index in the mammal;

measuring acceleration index in the mammal;

determining a first deviation, if any, from a preselected volemic state;

determining a second deviation, if any, from a preselected capacitive state;

determining a third deviation, if any, from a preselected inotropic state; and

administering a therapeutic dose of at least one pharmacologically active material for altering the first, second and third deviations to achieve a preselected hemodynamic state.

22. A method of achieving a preselected hemodynamic state as defined in claim 21, wherein the preselected volemic state is normovolemia.

23. A method of achieving a preselected hemodynamic state as defined in claim 22, wherein the volemic state is measured as the left cardiac work index and ranges from approximately 3.3 to 5.3 kg.m/m².

24. A method of achieving a preselected hemodynamic state as defined in claim 21, wherein the preselected capacitive state is normocapacitance.

25. A method of achieving a preselected hemodynamic state as defined in claim 21, wherein the preselected hemodynamic state comprises normovolemia, normoinotropy and arterial normocapacitance.

26. A method of achieving a preselected hemodynamic state as defined in Claim 21, wherein the preselected hemodynamic state comprises a mean arterial pressure of from about 84 to about 100 Torr.

27. A method of achieving a preselected hemodynamic state as defined in Claim 21, further comprising the step, prior to the administering step, of selecting a pharmacologically active material for reducing the deviation from the preselected volemic state.

28. A method of achieving a preselected hemodynamic state as defined in Claim 21, wherein the mammal is a human adult in postoperative recovery and the preselected hemodynamic state comprises normotension and hyperdynamic global blood flow.

29. A method of determining and correcting deviations from normodynamic circulation, consisting of normovolemia, normovasoactivity and normoinotropy, in a subject mammal, comprising the steps of:

(a) determining the subject'"'"'s mean arterial pressure (MAP);

(b) measuring the subject'"'"'s cardiac index (CI);

(c) determining the subject'"'"'s left cardiac work index (LCWI) utilizing the measured MAP and CI values according to the formula;

space="preserve" listing-type="equation">LCWI=(MAP-PAOP)×

CI×

K

wherein PAOP is the pulmonary artery occluded pressure and K is a constant;

(d) determining a first deviation from normal LCWI by utilizing the determined value for LCWI according to the formula;

##EQU8## (e) measuring the subject'"'"'s acceleration index (ACI);

(f) determining a second deviation from normoinotropy by utilizing the measured value for ACI according to the formula;

space="preserve" listing-type="equation">deviation=ACI/normal ACI

(g) determining a third deviation from normovolemia, comprising subtracting the second deviation from the first deviation;

(h) determining the subject'"'"'s systemic vascular resistance index utilizing the measured MAP and CI values according to the formula;

##EQU9## wherein SVRI represents the systemic vascular resistance index, CVP is central venous pressure and L is a constant;

(i) determining a fourth deviation from normovasoactivity by utilizing the determined value for SVRI according to the formula;

##EQU10## (j) increasing fluid volume if the third deviation is not substantially zero and the first deviation is less than 1.0, and decreasing fluid volume if the third deviation is not substantially zero and the first deviation is greater than 1.0;

(k) causing vasodilation in the subject if the fourth deviation is greater than 1.0, and causing vasorestriction if the fourth deviation is less than 1.0; and

(l) causing a negative inotropic effect in the subject if the second deviation is greater than 1.0, and causing a positive inotropic effect in the subject if the second deviation is greater than 1.0.

30. The method of claim 29, wherein steps (j), (k) and (l) each comprise the administration to the subject of a pharmacologically active material.

31. The method of claim 30, wherein each of steps (a) through (l) is repeated one or more times for the same subject, and wherein the amount pharmacologically active material administered each subsequent time the steps are repeated is increased or decreased until the difference of each of the determined deviation from 1.0 is substantially zero.

36. The method of any one of claims 35, 29 or 34 wherein normal LCWI is equal to 4.35 kg.m/m².

37. The method of any one of claim 35, 29 or 34 wherein normal ACI is equal to 1.0/sec².

38. The method of any one of claim 29, 32 or 34 wherein normal SVRI is equal to 2030 hyn.sec/cm⁵ m².

32. A method of determining and correcting deviations from normovasoactivity in a subject mammal, comprising the steps of:

(a) determining the subject'"'"'s mean arterial pressure (MAP);

(b) measuring the subject'"'"'s cardiac index (CI);

(c) determining the subject'"'"'s systemic vascular resistance index utilizing the measured MAP and CI values according to the formula;

##EQU11## wherein SVRI represents the systemic vascular resistance index, CVP is central venous pressure and L is a constant;

(d) determining a deviation from normovasoactivity by utilizing the determined value for SVRI according to the formula;

##EQU12## and;

(e) administering a pharmacologically vasoconstrive material if the deviation is less than one, and administering a pharmacologically vasocilating material if the deviation is greater than one.

33. The method of claim 32, additionally comprising

repeating each of steps (a) through (e) one or more times in the same subject;

and

increasing the amount of pharmacologically vasoconstrictive material if the deviation remains less than one, decreasing the amount of pharmacologically vasoconstrictive material if the deviation changes from less than one to greater than one, increasing the amount of pharmacologically vasodilating material if the deviation remains greater than one, and decreasing the amount of pharmacologically vasodilating material if the deviation changes from greater than one to less than one.

34. A method of determining deviations from normodynamic circulation, consisting of normoinotropy, normovolemia and normovasoactivity in a subject mammal, comprising:

(a) determining the subject'"'"'s mean arterial pressure (MAP);

(b) measuring the subject'"'"'s cardiac index (CI);

(c) determining the subject'"'"'s left cardiac work index (LCWI) utilizing the measured MAP and CI values according to the formula;

space="preserve" listing-type="equation">LCWI=(MAP-PAOP)×

CI×

K

wherein PAOP is the pulmonary artery occluded pressure and K is a constant;

(d) determining a deviation (1) from normal LCWI by utilizing the determined value for LCWI according to the formula;

##EQU13## (e) measuring the subject'"'"'s acceleration index (ACI);

(f) determining the deviation (2) in inotropy from normoinotropy by utilizing the measured value for ACI according to the formula;

space="preserve" listing-type="equation">deviation (2)=ACI/normal ACI

(g) determining the deviation (3) in volemia from normovolemia, comprising subtracting deviation (2) from deviation (1);

(h) determining the subject'"'"'s systemic vascular resistance index utilizing the measured MAP and CI values according to the formula;

##EQU14## wherein SVRI represents the systemic vascular resistance index, CVP is central venous pressure and L is a constant; and

(i) determining deviation (4) in vasoactivity from normovasoactivity by utilizing the determined value for SVRI according to the formula;

##EQU15##

35. A method of determining and correcting devaitions from normovolemia in a subject mammal, comprising the steps of:

(a) determining the subject'"'"'s mean arterial pressure (MAP);

(b) measuring the subject'"'"'s cardiac index (CI);

(c) determining the subject'"'"'s left cardiac work index (LCWI) utilizing the measured MAP and CI values according to the formula;

space="preserve" listing-type="equation">LCWI=(MAP-PAOP)×

CI×

K

wherein PAOP is the pulmonary artery occulded pressure and K is a constant;

(d) determining a first deviation from normal LCWI by utilizing the determined value for LCWI according to the formula;

##EQU16## (e) measuring the subject'"'"'s acceleration index (ACI);

(f) determining a second deviation from normoinotropy by utilizing the measured value for ACI according to the formula;

space="preserve" listing-type="equation">deviation=ACI/normal ACI

(g) determining a third deviation from normovolemia, comprising subtracting the second deviation from the first deviation; and

(h) increasing fluid volume if the third deviation is zero or negative and the first deviation is less than 1.0, and decreasing fluid volume if the third deviation is zero or positive and the first deviation is greater than 1.0.