System and method for transparent early detection, warning, and intervention during a medical procedure

• US 20030214409A1
• Filed: 05/13/2003
• Published: 11/20/2003
• Est. Priority Date: 05/13/2002
• Status: Active Grant

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S.
• Granted Patent: US 7,034,692 B2
• Time in Patent Office: Days
• US Class Current: 340/573.1
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

The present invention relates, in general, to prevention of false, annoying, or oversensitive alarms, providing early detection by a sensitive test, generating silent, semi-overt, or overt alarm conditions and/or initiating early passive or active interventions to untoward events. The invention buys time by providing an early intervention in the event that a highly sensitive early detection is later confirmed by a specific test. A particular embodiment of the invention is directed to the early detection of hypoventilation, including apnea and airway obstruction, and the pausing or interrupting of an action such as drug delivery during medical procedures.

Claims

1. A drug delivery system for use during the performance of a medical procedure that monitors the ventilatory conditions of a patient and provides automated responses to certain of those conditions comprising:

a respiratory gas exchange monitor including means to output monitoring data;

a high-sensitivity alarm algorithm to process said monitoring data;

a high-specificity alarm algorithm to process said monitoring data; and

an automated device for controlling a drug delivery mechanism in response to said data processed by said high-sensitivity and high-specificity alarm algorithms.

2. The system according to claim 1, wherein said system reduces false positive and false negative alarms in a manner that is transparent to a user.

3. The system according to claim 2, wherein said high sensitivity alarm algorithm utilizes a moving average of said monitoring data.

4. The system according to claim 2, wherein said high specificity alarm algorithm utilizes a cumulative sum of said monitoring data.

5. The system according to claim 2, wherein said high sensitivity alarm algorithm is used for early detection of untoward conditions.

6. The system according to claim 5, wherein said early detection is used to activate a silent alarm and a hypervigilant state.

7. The system according to claim 5, wherein said early detection is used to activate at least one of a semi-overt alarm and a silent alarm.

8. The system according to claim 5, wherein said early detection is used to initiate an action.

9. The system according to claim 8, wherein said action may be passive intervention.

10. The system according to claim 9, wherein a discontinuation of said highly sensitive alarm activates a cessation of said passive action and a stand down from said hypervigilant condition.

11. The system according to claim 8, wherein said action may be active intervention.

12. The system according to claim 11, wherein a discontinuation of said highly sensitive alarm causes activates a cessation of said active action and a stand down from said hypervigilant condition.

13. The system according to claim 5, wherein said high specificity alarm algorithm provides one of a confirmation and a contradiction of an alarm condition resulting from said highly sensitive alarm algorithm.

14. The system according to claim 13, wherein said confirmation is used to generate an overt alarm condition.

15. The system according to claim 13, wherein said confirmation is used to conduct one of an initiation and continuation of an automated corrective action.

16. The system according to claim 13, wherein said contradiction is used to maintain said hypervigilant state so long as said alarm condition resulting from said highly sensitive alarm algorithm continues.

17. The system according to claim 1, wherein said drug delivery system is a sedation and analgesia system.

18. The system according to claim 17, wherein said respiratory gas exchange monitor measures CO₂ levels of said patient.

19. The system according to claim 18, wherein said drug delivery mechanism administers at least one drug that may act as a respiratory depressant.

20. The system according to claim 19, wherein said at least one drug is propofol.

21. A method for administering drugs to a patient that monitors the ventilatory conditions of said patient during drug delivery and provides automated responses to certain of those conditions comprising the steps of:

measuring a first parameter that is indicative of a second parameter that a clinician desires to monitor and control;

using said measured first parameter to generate first derived values of said first parameter that are sensitive indicators of the status of said second parameter;

using said measured first parameter to generate second derived values of said first parameter that are specific indicators of the status of said second parameter;

conducting a sensitive test based on said first derived values of said first parameter;

if said sensitive test passes, performing at least one of continuing said drug delivery, resuming said drug delivery, and disabling said silent alarm based on the results of said sensitive test and said specific test;

if said sensitive test fails, performing at least one of pausing said drug delivery, initiating a hypervigilant condition, and activating a silent alarm, and conducting a confirmation test based on said second derived values of said first parameter;

if said confirmation test passes, performing at least one of resuming said stopped action and disabling said overt alarms; and

if said confirmation test fails, activating an overt alarm and stopping actions relating to drug delivery.

22. The system according to claim 21, wherein said first parameter and said second parameter are the same.

23. The system according to claim 21, wherein multiple first parameters are measured.

24. The system according to claim 21, further comprising the step of evaluating said sensitive indicators and proceeding to further tests only upon failure of said sensitive test.

25. The system according to claim 21, wherein said sensitive test further comprises comparing said derived values of said first parameter to a predetermined threshold.

26. The system according to claim 21, wherein said confirmation test further comprises comparing said derived values of said first parameter to a predetermined threshold.

27. A system for use during the performance of a medical procedure that monitors selected medical conditions of a patient and provides automated responses to certain of said conditions comprising:

a monitor that measures selected medical parameters including means to output monitoring data regarding said medical parameters;

a high-sensitivity alarm algorithm to process said monitoring data;

a high-specificity alarm algorithm to process said monitoring data; and

automated means for responding to said high-sensitivity and high-specificity alarm algorithms.

28. The system according to claim 27, wherein said system reduces false positive and false negative alarms in a manner that is transparent to a user.

29. The system according to claim 28, wherein said high sensitivity alarm algorithm utilizes a moving average of said monitoring data.

30. The system according to claim 28, wherein said high specificity alarm algorithm utilizes a cumulative sum of said monitoring data.

31. The system according to claim 28, wherein said high sensitivity alarm algorithm is used for early detection of untoward conditions.

32. The system according to claim 31, wherein said early detection is used to activate a silent alarm and a hypervigilant state.

33. The system according to claim 31, wherein said early detection is used to activate at least one of a semi-overt alarm and a silent alarm.

34. The system according to claim 31, wherein said early detection is used to initiate an action.

35. The system according to claim 34, wherein said action may be passive intervention.

36. The system according to claim 35, wherein a discontinuation of said highly sensitive alarm activates a cessation of said passive action and a stand down from said hypervigilant condition.

37. The system according to claim 34, wherein said action may be active intervention.

38. The system according to claim 37, wherein a discontinuation of said highly sensitive alarm causes activates a cessation of said active action and a stand down from said hypervigilant condition.

39. The system according to claim 31, wherein said high specificity alarm algorithm provides one of a confirmation and a contradiction of an alarm condition resulting from said highly sensitive alarm algorithm.

40. The system according to claim 39, wherein said confirmation is used to generate an overt alarm condition.

41. The system according to claim 39, wherein said confirmation is used to conduct one of an initiation and continuation of an automated corrective action.

42. The system according to claim 39, wherein said contradiction is used to maintain said hypervigilant state so long as said alarm condition resulting from said highly sensitive alarm algorithm continues.

43. A drug delivery system for use during the performance of a medical procedure that monitors ventilatory conditions of a patient and provides automated responses to certain of those conditions comprising:

means for monitoring said ventilatory conditions, wherein said monitoring means includes means to output monitoring data;

means for processing said monitoring data using a high-sensitivity alarm algorithm;

means for processing said monitoring data using a high-specificity alarm algorithm; and

automated means for controlling a drug delivery mechanism in response to said processed data.

44. The system according to claim 43, wherein said system reduces false positive and false negative alarms in a manner that is transparent to a user.

45. The system according to claim 44, wherein said high sensitivity alarm algorithm is used for early detection of untoward conditions.

46. The system according to claim 45, wherein said early detection is used to initiate an action.

48. The method according to claim 43, wherein said system reduces false positive and false negative alarms in a manner that is transparent to a user.

49. The method according to claim 44, wherein said high sensitivity alarm algorithm is used for early detection of untoward conditions.

50. The method according to claim 45, wherein said early detection is used to initiate an action.

47. A method of drug delivery for use during the performance of a medical procedure that monitors ventilatory conditions of a patient and provides automated responses to certain of those conditions comprising:

monitoring said ventilatory conditions, wherein said monitoring means includes means to output monitoring data;

processing said monitoring data using a high-sensitivity alarm algorithm;

processing said monitoring data using a high-specificity alarm algorithm; and

controlling a drug delivery mechanism in response to said processed data.