Temperature monitoring of congestive heart failure patients as an indicator of worsening condition

• US 20030092975A1
• Filed: 09/19/2002
• Published: 05/15/2003
• Est. Priority Date: 03/08/1999
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Payvar, Saeed, Casscells, Samuel Ward III
• Granted Patent: US 6,821,249 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

Indication of worsening health condition in patients with congestive heart failure using the analysis of the speed and pattern of temperature change in a way that is individualized toward patient'"'"'s health condition.

Claims

1. A method alerting a worsening of condition in a patient with congestive heart failure, which comprises:

(a) pre-setting a cut-off point of at least one temperature attribute of hypothermia comprising rate of fall of body temperature relative to optimum sensitivity and specificity for such attribute as a congestive heart failure predictor of death of a patient,

(b) routinely determining that attribute in the patient, and

(c) determining from said routine determinations of said attribute whether a condition of congestive heart failure hypothermia has occurred, and if so,

(d) issuing an alert warning of said worsening condition.

2. The method of claim 1 in which said operation (c) comprises determining whether said attribute has attained or crossed said cut-off point.

3. The method of claim 1 further comprising routinely determining said attribute for at least one peripheral site and for a core site and in which said operation (c) comprises determining whether said attribute in both said sites are moving in the direction of said cut-off point

4. The method of claim 1 in which said operation (c) comprises determining whether rise of core temperature of the patient from a temperature below a baseline temperature of the patient to a temperature at or closer to baseline lags behind rise of core temperature of the normal person from a temperature below a baseline temperature of the normal person to a temperature at or closer to baseline, or if the core temperature of the patient rises from a temperature below a baseline temperature of the patient to less than a predetermined minimum acceptable rise.

5. A method caring for a patient with congestive heart failure, which comprises:

(a) pre-setting a cut-off point of at least one temperature attribute of hypothermia comprising rate of fall of body temperature relative to optimum sensitivity and specificity for such attribute as a congestive heart failure predictor of death of a patient,

(b) routinely determining that attribute in the patient, and

(c) determining whether said attribute has attained or crossed said cut-off point.

6. The method of claim 5 in which optimum sensitivity and specificity for rate of fall of body temperature is 0.4°

F. per hour.

7. The method of claim 5 in which said temperature attribute additionally comprises a hypothermic body temperature.

8. The method of claim 7 in which optimum sensitivity and specificity for hypothermic body temperature is 95°

F.

9. The method of claim 5 in which said cut-off point is pre-set as (i) the optimum sensitivity and specificity value of said temperature attribute, (ii) an increase in the sensitivity of said cut-off point from the optimum sensitivity and specificity value of said temperature attribute, or (iii) a decrease in the sensitivity of said cut-off point from the optimum sensitivity and specificity value of said temperature attribute.

10. The method of claim 5 further comprising:

(d) outputting an alert if said temperature attribute has attained or crossed said cut-off point.

11. The method of claim 10 in which said alert is output at least to the patient.

12. The method of claim 10 in which said alert is output at least to a healthcare provider.

13. The method of claim 10 in which said alert is output at least to a device.

14. The method of claim 13 in which said device is a medical device that applies a therapeutic treatment to said patient to treat the patient'"'"'s condition of congestive heart failure.

15. The method of claim 14 in which said device is a ventricular assist device responsive to said alert to provide additional ventricular assist to the patient.

16. The method of claim 14 in which said device is a medication release device responsive to said alert to adjust the amount of medication the patient is receiving.

17. The method of claim 14 in which said device is a cardiac rhythmic regulator, responsive to said alert to optimize the patient'"'"'s regulator parameters to reverse hypothermia.

18. The method of claim 14 in which said device is responsive to said alert to warm the patient.

19. The method of claim 10 in which the cut-off point is a selected increase or decrease of sensitivity of said cut-off point from said optimum specificity and sensitivity value of said temperature attribute, chosen to output an alert at a time that best suits the patient'"'"'s condition considering at least one of (a) at least one prognostic factor other than said temperature attribute, (b) at least one co-morbidity, and (c) availability of immediate care by a healthcare provider.

20. The method of claim 19 in which said at least one prognostic factor is selected from chest impedance peak oxygen uptake (dot(V)O2), left and right ventricular ejection function, both respiratory and circulatory response to exercise, cardiac index, left ventricular cavity size, left ventricular stroke work index, right and left ventricular filling pressure, left ventricular filling isovolumic relaxation time, left ventricular systolic pressure, right and left atrial pressure, systemic vascular resistance, calculated wall stress, tricuspid regurgitation, jugular venous pressure, pulmonary capillary wedge pressure, 6 -minute walk distance, arterial and venous pH, pO2, pCO2, serum creatinine, serum sodium, plasma norepinephrine, plasma neurotensin, plasma renin activity, plasma arginine vasopressin, plasma atrial and brain natriuretic peptides, plasma endothelin-1, plasma interleukin-6, plasma tumor necrosis-alpha, serum sodium, serum potassium, total potassium stores, serum magnesium, lymphocyte count, frequent ventricular extrasystoles, ventricular tachycardia, left bundle-branch blockage, right bundle-branch blockage, atrial fibrillation or flutter, T-wave alternans, QT prolongation, QT dispersion, age, sex, ischemic heart disease, New York Hear Association functional class, S3 gallop, Cheyne-Stokes respiration, apnea/hypopnea index, systolic blood pressure, heart rate at rest, pulse pressure, mean arterial pressure, and cardiac cachexia.

21. The method of claim 20 in which at least one of the prognostic factors is present, and comprising pre-setting said cut-off point at an increased sensitivity of said temperature attribute from the optimum sensitivity and specificity for that temperature attribute.

22. The method of claim 19 in which said co-morbidity is any of (a) Alzheimer'"'"'s disease or other dementia, (b) depressive mood, and (c) motor disability, and wherein output of said alert is directed to at least to a healthcare provider.

23. The method of claim 19 in which availability of immediate care by a healthcare provider includes care available (i) as intensive care, (ii) as in-patient care not intensive care, (iii) as care within up to about 24 hours for an out-patient, and (iv) as care with more than about 24 hours delay for an out-patient, and comprising pre-setting said temperature attribute cut-off point in a range from a larger decrease, for care available as intensive care, to an larger increase, for care available with more than 24 hours delay, from optimum sensitivity and specificity for that temperature attribute.

24. The method of claim 5 further comprising determining and making adjustments of said periodically determined temperature attributes or said cut-off point on the basis of one or more of the patient'"'"'s environmental temperature and light.

25. The method of claim 5 further comprising determining and making adjustments of said periodically determined temperature attributes or said cut-off point on the basis of one or more of the patient'"'"'s activity, medications, smoking, alcohol use, and solid and/or fluid intake temperature.

26. The method of claim 10, comprising periodically ascertaining body temperature, and further comprising

(e) determining maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration and the frequency of such intervals, to define a set,

(f) determining whether said set exceeds limits of at least one predefined pattern of maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration and the frequency of such intervals, and if so,

(g) outputting an alert.

27. The method of claim 10 in which said cut-off point is referenced to normal body temperature, and further comprising determining a selected measure of central tendency and measure of dispersion of the patient'"'"'s body temperatures to define the patient'"'"'s own baseline body temperature.

28. The method of claim 27, further comprising:

(e) re-referencing said cut-off point from said normal body temperature to said baseline body temperature, and

(f) determining whether said temperature attribute of hypothermia has attained or crossed said re-referenced cut-off point, and if so,

(g) outputting an alert.

29. The method of claim 28, comprising periodically ascertaining body temperature, and further comprising

(h) ascertaining body temperatures at intervals in which such temperatures are lower than said baseline temperature, to define a set,

(i) determining whether said set exceeds limits of at least one predefined pattern of maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration and the frequency of such intervals, and if so,

(j) outputting an alert.

30. The method of claim 5 further comprising routinely determining said attribute for at least one peripheral site and for a core site and determining whether said attribute in both said sites is moving in the direction of said cut-off point, and if so, outputting an alert.

31. A method of monitoring and warning of worsening of condition of congestive heart failure in a patient, which comprises:

(a) pre-setting a cut-off point of at least one temperature attribute of hypothermia comprising rate of fall of body temperature relative to optimum sensitivity and specificity for that temperature attribute as a congestive heart failure predictor of death of a patient, referenced to normal body temperature,

(b) routinely determining a selected measure of central tendency and measure of dispersion of body temperatures to define the patient'"'"'s own baseline body temperature,

(c) re-referencing said cut-off point from said normal body temperature to said baseline body temperature, and

(d) routinely determining whether said temperature attribute has attained or crossed said cut-off point before and after said re-referencing, and if so, outputting an alert.

32. A method of monitoring and warning of worsening of condition of congestive heart failure in a patient, which comprises:

(a) pre-setting a cut-off point of at least one temperature attribute of hypothermia comprising rate of fall of body temperature relative to optimum sensitivity and specificity for that temperature attribute as a congestive heart failure predictor of death of a patient, referenced to normal body temperature,

(b) ascertaining body temperatures of the patient in intervals of time,

(c) determining whether said temperature attribute has attained or crossed said cut-off point, and if so, outputting an alert,

(d) determining a selected measure of central tendency and measure of dispersion of body temperatures to define the patient'"'"'s own baseline body temperature,

(e) re-referencing each said cut-off point from said normal body temperature to said baseline body temperature, and

(f) determining whether said temperature attribute has attained or crossed said re-referenced cut-off point, and if so, outputting an alert.

33. The method of claim 32 further comprising determining adjustments of said ascertained body temperatures on the basis of one or more of the patient'"'"'s environmental temperature and light.

34. The method of claim 32 further comprising determining adjustments of said ascertained body temperatures on the basis of one or more of the patient'"'"'s activity, medications, smoking, alcohol use, and solid and/or fluid intake temperature.

35. The method of claim 34 further comprising determining adjustments of said ascertained body temperatures on the basis of one or more of the patient'"'"'s environmental temperature and light.

36. A method of monitoring and warning of worsening of condition of congestive heart failure in a patient, which comprises:

(a) setting a cut-off point for temperature and rate of fall of temperature as temperature attributes of hypothermia relative to optimum sensitivity and specificity for those temperature attributes as a congestive heart failure predictor of death of a patient, basis normal body temperature,

(b) ascertaining body temperatures of the patient in intervals of time,

(c) determining whether a said temperature attribute has attained or crossed said cut-off point, and if so outputting an alert thereof,

(d) determining maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration and the frequency of such intervals, as a set,

(e) determining whether said set exceeds limits of at least one predefined pattern of maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration and the frequency of such intervals, and if so, outputting an alert,

(f) determining a selected measure of central tendency and measure of dispersion of body temperatures to define the patient'"'"'s own baseline body temperature,

(g) re-referencing each said cut-off point and said predefined pattern limits from said normal body temperature to said baseline body temperature,

(h) determining whether said temperature attribute has attained or crossed said re-referenced cut-off point, and if so, outputting an alert, and

(i) determining whether said set exceeds said re-referenced predefined pattern limits, and if so, outputting an alert.

37. :

A method of monitoring and warning of worsening of condition of congestive heart failure in a patient, which comprises;

(a) monitoring and recording environmental temperature and core temperature of the patient,

(b) determining whether a steep fall in environmental temperature has occurred, and if so,

(c) comparing the patient'"'"'s core temperature and the patient'"'"'s change in core temperature over time to a core temperature and a change in core temperature over time of a normal person at environmental temperatures monitored beginning with the temperatures included in said steep fall, and

(d) issuing an alert if rise of core temperature of the patient from a temperature below a baseline temperature of the patient to a temperature at or closer to baseline lags behind rise of core temperature of the normal person from a temperature below a baseline temperature of the normal person to a temperature at or closer to baseline, or if the core temperature of the patient rises from a temperature below a baseline temperature of the patient to less than a predetermined minimum acceptable rise.

38. Apparatus for monitoring a patient with congestive heart failure for worsening of condition thereof, which comprises:

(a) means for pre setting a cut-off point of at least one temperature attribute of hypothermia comprising rate of fall of body temperature relative to optimum sensitivity and specificity for that temperature attribute as a congestive heart failure predictor of death of a patient,

(b) means for routinely determining that temperature attribute of the patient, and

(c) means for determining whether said temperature attribute has attained or crossed said cut-off point.

39. The apparatus of claim 38 in which optimum sensitivity and specificity for rate of fall of body temperature of 0.4°

F. per hour.

40. The apparatus of claim 38 in which said temperature attribute also comprises a hypothermic body temperature of the patient.

41. The apparatus of claim 38 in which optimum sensitivity and specificity for hypothermic body temperature is 95°

F.

42. The apparatus of claim 38 further comprising means for routinely determining said at least one attribute at least one peripheral site and at a core site of the patient and for determining whether said at least one attribute in both said sites are moving in the direction of said cut-off point, and if so, outputting an alert.

43. The apparatus of claim 38 in which said cut-off point is pre-set as (i) the optimum sensitivity and specificity value of said temperature attribute, (ii) an increase in the sensitivity of said cut-off point from the optimum sensitivity and specificity value of said temperature attribute, or (iii) a decrease in the sensitivity of said cut-off point from the optimum sensitivity and specificity value of said temperature attribute.

44. The apparatus of claim 38 further comprising:

(d) means for outputting an alert operative on the condition that said temperature attribute has attained or crossed said cut-off point.

45. The apparatus of claim 44 in which said alert is output at least to the patient.

46. The apparatus of claim 44 in which said alert is output at least to a healthcare provider.

47. The apparatus of claim 44 in which said alert is output at least to a device.

48. The apparatus of claim 47 in which said device is a medical device that applies a therapeutic treatment to said patient to treat the patient'"'"'s condition of congestive heart failure.

49. The apparatus of claim 48 in which said device is a ventricular assist device responsive to said alert to provide additional ventricular assist to the patient.

50. The apparatus of claim 48 in which said device is an intravenous infusion device responsive to said alert to adjust the amount of medication the patient is receiving.

51. The apparatus of claim 48 in which said device is a cardiac rhythmic regulator, responsive to said alert to optimize the patient'"'"'s regulator parameters to reverse hypothermia.

52. The apparatus of claim 48 in which said device is responsive to said alert to warm the patient.

53. The apparatus of claim 44 in which the cut-off point is a selected increase or decrease of sensitivity of said cut-off point from said optimum specificity and sensitivity value of said temperature attribute, chosen to output an alert at a time that best suits the patient'"'"'s condition considering at least one of (a) at least one prognostic factor other than said temperature attribute, (b) at least one co-morbidity, and (c) availability of immediate care by a healthcare provider.

54. The apparatus of claim 53 in which said at least one prognostic factor is selected from any of chest impedance peak oxygen uptake (dot(V)O2), left and right ventricular ejection function, both respiratory and circulatory response to exercise, cardiac index, left ventricular cavity size, left ventricular stroke work index, right and left ventricular filling pressure, left ventricular filling isovolumic relaxation time, left ventricular systolic pressure, right and left atrial pressure, systemic vascular resistance, calculated wall stress, tricuspid regurgitation, jugular venous pressure, pulmonary capillary wedge pressure, 6-minute walk distance, arterial and venous pH, pO2, pCO2, serum creatinine, serum sodium, plasma norepinephrine, plasma neurotensin, plasma renin activity, plasma arginine vasopressin, plasma atrial and brain natriuretic peptides, plasma endothelin-1, plasma interleukin-6, plasma tumor necrosis-alpha, serum sodium, serum potassium, total potassium stores, serum magnesium, lymphocyte count, frequent ventricular extrasystoles, ventricular tachycardia, left bundle-branch blockage, right bundle-branch blockage, atrial fibrillation or flutter, T-wave alternans, QT prolongation, QT dispersion, age, sex, ischemic heart disease, New York Hear Association functional class, S3 gallop, Cheyne-Stokes respiration, apnea/hypopnea index, systolic blood pressure, heart rate at rest, pulse pressure, mean arterial pressure, and cardiac cachexia.

55. The apparatus of claim 44 further comprising means for determining adjustments of said determined at least one temperature attribute on the basis of one or more of the patient'"'"'s environmental temperature and light.

56. The apparatus of claim 44 further comprising means for determining adjustments of said determined at least one temperature attribute on the basis of one or more of the patient'"'"'s activity, medications, smoking, alcohol use, and solid and/or fluid intake temperature.

57. The apparatus of claim 44 in which said means for routinely determining said temperature attribute comprises means for ascertaining the body temperature of the patient and means for determining maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration and the frequency of such intervals, as a set, said apparatus further comprises means for determining whether said set exceeds limits of a predefined pattern of maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration and the frequency of such intervals.

58. The apparatus of claim 44 in which said means for routinely determining said temperature attribute comprises means for ascertaining the body temperature of the patient and means for determining a selected measure of central tendency and measure of dispersion of the patient'"'"'s body temperatures to define the patient'"'"'s own baseline body temperature.

59. The apparatus of claim 58, in which said means for routinely determining said temperature attribute further comprises means for re-referencing said cut-off point from said normal body temperature to said baseline body temperature.

60. The apparatus of claim 59 in which said means for routinely determining said temperature attribute further comprises means for ascertaining the body temperature of the patient and means for determining maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration and the frequency of such intervals, as a set, said apparatus further comprises means for determining whether said set exceeds limits of a predefined pattern of maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration and the frequency of such intervals.

61. Apparatus for monitoring and warning of worsening of condition of congestive heart failure in a patient, which comprises:

(a) means for pre-setting a cut-off point of at least one temperature attribute of hypothermia comprising rate of fall of body temperature relative to optimum sensitivity and specificity for that temperature attribute as a congestive heart failure predictor of death of a patient, referenced to normal body temperature,

(b) means for determining body temperature of the patient in intervals of time,

(c) means for routinely determining a selected measure of central tendency and measure of dispersion of body temperatures to define the patient'"'"'s own baseline body temperature,

(d) means for re-referencing each said cut-off point from said normal body temperature to said baseline body temperature, and

(e) means for routinely determining whether said temperature attribute has attained or crossed said cut-off point before and after said re-referencing, and

(f) means for outputting an alert on condition that said temperature attribute has attained or crossed said cut-off point before and after said re-referencing.

62. The apparatus of claim 61 further comprising means for adjusting said body temperatures on the basis of one or more of the patient'"'"'s environmental temperature and light.

63. The apparatus of claim 61 further comprising means for adjusting said body temperatures on the basis of one or more of the patient'"'"'s activity, medications, smoking, alcohol use, and solid and/or fluid intake temperature.

64. The apparatus of claim 63 further comprising means for adjusting said body temperatures on the basis of one or more of the patient'"'"'s environmental temperature and light.

65. Apparatus for monitoring and warning of worsening of condition of congestive heart failure in a patient, which comprises:

(a) means for setting a cut-off point for temperature and rate of fall of temperature as temperature attributes of hypothermia relative to optimum sensitivity and specificity for those temperature attribute as a congestive heart failure predictor of death of a patient, referenced to normal body temperature,

(b) means for ascertaining body temperatures of the patient in intervals of time

(c) means for determining said temperature attributes of the patient at predetermined intervals of time,

(d) means for determining whether a said temperature attribute has attained or crossed said cut-off point,

(e) means for determining maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration and the frequency of such intervals, as a set,

(f) means for determining whether said set exceeds limits of a predefined pattern of maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration and the frequency of such intervals,

(g) means for determining a selected measure of central tendency and measure of dispersion of the patient'"'"'s body temperatures to define the patient'"'"'s own baseline body temperature,

(h) means for re-referencing each said cut-off point and said predefined pattern limits from said normal body temperature to said baseline body temperature,

(i) means for determining whether a said temperature attribute of hypothermia has attained or crossed said re-referenced cut-off point,

(j) means for determining whether a said set exceeds said re-referenced predefined pattern limits, and

(k) means for outputting an alert on condition of a said temperature attribute has attained or crossed said cut-off point before or after a re-referencing of each said cut-off point to said baseline temperature, and on condition of a said set exceeding said predefined pattern limits before or after re-referencing said predefined pattern limits to said baseline temperature.

66. The apparatus of claim 65 further comprising means for adjusting said ascertained body temperatures on the basis of one or more of the patient'"'"'s environmental temperature and light.

67. The apparatus of claim 65 further comprising means for adjusting said ascertained body temperatures on the basis of one or more of the patient'"'"'s activity, medications, smoking, alcohol use, and solid and/or fluid intake temperature.

68. The apparatus of claim 67 further comprising means for adjusting said ascertained body temperatures on the basis of one or more of the patient'"'"'s environmental temperature and light.

69. Apparatus monitoring and warning of worsening of condition of congestive heart failure in a patient, comprising:

(a) a temperature sensor for sensing body temperatures of a patient and outputting signals representative of the sensed temperatures,

(b) a mount of said temperature sensor for indwelling or external placement on the patient,

(c) an analyzer including a digital signal processor, program memory and data memory,

(d) said program memory containing a program data set having a cut-off point for at least rate of fall of body temperature as a temperature attribute of hypothermia point relative to optimum sensitivity and specificity for such temperature attribute as a congestive heart failure predictor of death of a patient,

(e) an algorithm in said program memory for instructing said processor to perform functions including periodically writing to said data memory data based on said temperature representation signals and reading data from said data memory, and periodically comparing data from data memory with data in said program data set to determine whether a temperature attribute including at least rate of fall of body temperature has attained or crossed said cut-off point, and if so, outputting a signal indicative of cut-off point attainment or crossover, and

(f) an alarm for receiving said output signal from said processor and expressing an alert.

70. The apparatus of claim 69 in which said data periodically written and read to and from said data memory includes body temperature, and said cut-off point in said program memory set includes a body temperature cut-off point.

71. The apparatus of claim 69 in which said data periodically written and read to and from said data memory includes a calculated rate of fall of body temperature.

72. The apparatus of claim 69 in which said algorithm includes instructions for instructing said processor to determine a selected measure of central tendency and measure of dispersion of patient body temperature to define the patient'"'"'s own baseline body temperature, and to re-reference said cut-off point to said baseline body temperature.

73. The apparatus of claim 69 in which said program data set is further characterized as comprising a range of sensitivity and specificity pairs, each pair having a cut-off point for at least one temperature attribute of hypothermia as a congestive heart failure predictor of death of a patient, said range including a sensitivity and a specificity pair for an optimal cut-off point of said temperature attribute, and wherein said apparatus further comprises an adjuster communicable with said analyzer for pre-setting a said cut-off point relative to optimum sensitivity and specificity for that temperature attribute in said program data set.

74. The apparatus of claim 69 in which said program data set includes data comprising a predefined limit pattern of maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration and the frequency of such intervals, and wherein said algorithm includes instructions for instructing said processor (i) to periodically determine the maximum amount of body temperature fall in a selected interval, the interval'"'"'s duration, and the frequency of such intervals, as a set, (ii) to determine whether said set exceeds said limit pattern in said program data set, and if so, (iii) to output a signal indicative of attainment or crossover of said limit pattern.

75. The apparatus of claim 69 further comprising

(i) a sensor for detecting an environmental factor affecting patient temperature and outputting signals representative of the sensed environmental factor, and

(j) a mount for said environmental factor sensor for external placement on the patient;

and

wherein said algorithm includes instructions for receiving such signals representative of the sensed environmental factor and adjusting said signals representative of body temperature of the patient to correct for variation caused by said environmental factor.

76. The apparatus of claim 69 further comprising

(i) an activity sensor for detecting the patient'"'"'s activity and outputting signals representative of such activity,

(j) a mount for said activity sensor for external or internal placement on the patient, and

wherein said algorithm includes instructions for receiving said signals representative of patient activity and adjusting said signals representative of body temperature of the patient to correct for variation caused by patient activity.

77. The apparatus of claim 69 further comprising an input for adding or modifying information in said program data set.

78. The apparatus of claim 69 further comprising

(i) an input for entering data into said analyzer program data set by which said algorithm is able correct for variation in body temperature caused by one or more factors from among the group consisting essentially of medications, smoking, alcohol use, and solid and/or fluid intake temperature, and

wherein said algorithm includes instructions for adjusting said signals representative of body temperature of the patient to correct for variation caused by medications, smoking, alcohol use, and solid and/or fluid intake temperature.

79. The apparatus of claim 69 in which said mount is an indwelling medical device selected from the group consisting of an implanted capsule, a needle, tube, catheter, line, pacemaker, implanted pump and implanted defibrillator.

80. The apparatus of claim 79, wherein said tube is selected from the group consisting of a nasogastric tube, Dubbhoff tube, endotracheal tube, rectal tube, T-tubes, drain, and nasal probe.

81. The apparatus of claim 79, wherein said catheter is selected from the group consisting of a urinary catheter, pulmonary artery catheter, triple-lumen catheter, dialysis catheter, Hickman catheter, and infusion catheter.

82. The apparatus of claim 69, wherein said mount for external placement is selected from the group consisting of umbilical sensor, skin electrode, tympanic ear sensor, pulse oximeter, and casts.

83. The apparatus of claim 69 in which said temperature sensor is selected from the group consisting of a thermocouple, thermistor, thermosensitive chromophore, thermosensitive liquid crystal, infrared detector and ultrasound detector.

84. The apparatus of claim 69 in which said alert is a text display, sound, shock, change in color or shape, warmth, or vibration.

85. The apparatus of claim 69 in which said mount for said temperature sensor is a hearing aid.

86. The apparatus of claim 69 in which said mount for said sensor is wearable on the wrist of the patient.

87. The apparatus of claim 86 in which said wearable mount is a wrist watch into which the temperature sensor and said analyzer is integrated.

88. The apparatus of claim 69 further comprising a signal conditioner for preparing said signals representative of the sensed temperatures for use by said analyzer.

89. The apparatus of claim 88 in which said temperature sensor includes an infrared sensor mountable in an ear of a patient for sensing infrared radiation from tympanic membrane perfusion, and wherein said signal conditioner includes an infrared detector located remotely from the sensor and connected to the sensor by a cable, said signal conditioner further comprising a transducer for converting an analog signal to a digital signal representative of the body temperature sensed by said infrared sensor.

90. The apparatus of claim 89 in which said cable is an electrical cable and said signal is an electrical signal.

91. The apparatus of claim 89 in which said cable is an optical cable, said analog signal is an optical signal, and said digital signal is an electrical signal.

92. The apparatus of claim 89 in which said temperature sensor is a cholesteric crystal mountable on the skin of a patient, and wherein said signal conditioner includes:

an optical color illuminator and detector for illuminating said crystal and detecting spectral changes in said crystal as a result of change of temperature of the crystal and converting said detected changes to a digital signal for transmission to said analyzer, and

a fiber optic cable connecting said cholesteric crystal to said optical color illuminator and detector.

93. The apparatus of claim 89 in which said temperature sensor is a thermistor mountable on the skin of a patient, and wherein said signal conditioner comprises an amplifier and transducer for amplifying and converting an analog signal to a digital signal representative of the body temperature sensed by said thermistor.

94. The apparatus of claim 89 in which said temperature sensor is a temperature controlled oscillator implantable in the patient, and wherein said signal conditioner comprises a radio frequency transceiver for receiving wireless analog signals and transducing analog signals to digital signals representative of the body temperature sensed by said oscillator.

95. The apparatus of claim 69 in which said alert is output at least to the patient.

96. The apparatus of claim 69 in which said alert is output at least to a healthcare provider.

97. A system for monitoring and treating a congestive heart failure patient for worsening congestive heart failure, comprising:

(a) a temperature sensor for sensing body temperatures of a patient and outputting signals representative of the sensed temperatures,

(b) a mount of said temperature sensor for indwelling or external placement on the patient,

(c) an analyzer including a digital signal processor, program memory and data memory,

(d) said program memory containing a program data set having a cut-off point for at least rate of fall of body temperature as a temperature attribute of hypothermia point relative to optimum sensitivity and specificity for such temperature attribute as a congestive heart failure predictor of death of a patient,

(e) an algorithm in said program memory for instructing said processor to perform functions including periodically writing to said data memory data based on said temperature representation signals and reading data from said data memory, and periodically comparing data from data memory with data in said program data set to determine whether a temperature attribute including at least rate of fall of body temperature has attained or crossed said cut-off point, and if so, outputting a signal indicative of cut-off point attainment or crossover,

(f) a notifier for receiving said output signal from said processor and sending a notifying signal, and

(g) a device responsive to said notification signal for applying a therapeutic treatment to said patient to treat the patient'"'"'s condition of congestive heart failure.

98. The system of claim 97 in which said device is a ventricular assist device responsive to said notifying signal to provide additional ventricular assist to the patient.

99. The system of claim 97 in which said device is an intravenous infusion device responsive to said notifying signal to adjust the amount of medication the patient is receiving.

100. The system of claim 97 in which said device is a cardiac rhythmic regulator, responsive to said notifying signal to optimize the patient'"'"'s regulator parameters to reverse hypothermia.

101. The system of claim 97 in which said device is responsive to said notifying signal to warm the patient.

102. Apparatus for monitoring and warning of worsening of condition of congestive heart failure in a patient, which comprises:

(a) means for monitoring and recording environmental temperature and core temperature of the patient,

(b) means for determining whether a steep fall in environmental temperature has occurred, and if so,

(c) means comparing the patient'"'"'s core temperature and the patient'"'"'s change in core temperature over time to a core temperature and a change in core temperature over time of a normal person at environmental temperatures monitored beginning with the temperatures included in said steep fall, and

(d) means for issuing an alert if rise of core temperature of the patient from a temperature below a baseline temperature of the patient to a temperature at or closer to baseline lags behind rise of core temperature of the normal person from a temperature below a baseline temperature of the normal person to a temperature at or closer to baseline, or if the core temperature of the patient rises from a temperature below a baseline temperature of the patient to less than a predetermined minimum acceptable rise.