System and method of assessment of arousal, pain and stress during anesthesia and sedation

• US 20040015091A1
• Filed: 04/01/2003
• Published: 01/22/2004
• Est. Priority Date: 04/01/2002
• Status: Abandoned Application

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Aspect Medical Systems, LLC (Medtronic Plc)
• Inventors: Dahan, Albert, Greenwald, Scott D.
• Application Number:
  US10/404,869
• Publication Number:
  US 20040015091A1
• Time in Patent Office: Days
• US Class Current: 600/513
• CPC Class Codes: A61B 5/02125 of pulse wave propagation time
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/0285 Measuring or recording phase velocity of blood waves
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence

Abstract

A PTT monitoring system for measuring arousal and responses to stress or pain during sedation or anesthesia. includes ECG electrodes and a PPG probe connected to a computer via signal conditioning and digitizing hardware. Lead I is typically used as the ECG lead while the PPG probe is typically placed on a finger. The ECG and PPG waveforms are continuously analyzed to update and display a current estimate of the subject'"'"'s PPT from heart to hand. For each cardiac cycle, fiducial points are identified to indicate the pulse onset time (via QRS detection in the ECG) and pulse arrival time (via the point of steepest ascent in the PPG). The onset and arrival times for each cardiac cycle are paired, and the time difference is the interval estimate for that beat. An artifact post-processor (e.g., trim-mean filtering) excludes unlikely intervals from entering the averaged, current estimate of PTT. Finally, the current PTT estimate is displayed numerically and the trend of PTT is updated every second. Clinicians may interpret the instantaneous PTT value directly or in context of its recent trend. If there is a rapid decrease in PTT much less than the predetermined baseline value when the patient should be unconscious and free of stress and pain, then supplemental analgesics are administered to bring PTT greater than or equal to such baseline value.

Claims

1. A method of noninvasively monitoring and controlling stress, pain or arousal states during sedation or anesthesia comprising the steps of:

acquiring at least one ECG signal from a subject being analyzed;

acquiring an arterial pulse waveform;

processing said at least one ECG signal to identify a pulse initiation fiducial point;

processing said arterial pulse waveform to identify a pulse arrival fidicual point;

calculating the time difference between said pulse initiation fiducial point and said resultant pulse arrival fiducial points of cardiac cycles;

estimating a current PTT from a sequence of said time differences; and

adjusting the administration of analgesia based on clinical interpretation of PTT.

2. The method of claim 1 wherein said arterial pulse waveform is acquired through use of a photoplethysmograph.

3. The method of claim 1 wherein said arterial pulse waveform is acquired through use of a tonometer device.

4. The method of claim 1 wherein said arterial pulse waveform is acquired through use of an invasive arterial line.

5. The method of claim 1 wherein said pulse initiation fiducial point is determined by use of QRS detection.

6. The method of claim 1 wherein said pulse arrival fiducial point is determined by use of Pulse detection.

7. The method of claim 1 wherein the step of calculating the time difference between said pulse initiation fiducial point and said resultant pulse arrival fiducial point of a cardiac cycle further comprises the steps of:

for a pulse initiation fiducial point, identifying a resultant pulse arrival fiducial point within the following predetermined time interval;

if a pairing is identified, calculating the time difference between said initiation fiducial point and said arrival fiducial point; and

if a pairing is not identified, excluding data related to said pulse initiation fiducial point from further processing.

8. The method of claim 1 wherein said step of estimating said current PTT from a sequence of said time differences further comprises using the most recent value.

9. The method of claim 1 wherein said step of estimating said current PTT from a sequence of said time differences further comprises using the X% trim-mean over the last Y seconds, where X is 50% or 75%, and Y is between 5 and 30 seconds.

10. The method of claim 1 wherein said step of estimating said current PTT from a sequence of said time differences further comprises using median filtering over the last Y seconds where Y is between 5 and 30 seconds.

11. The method of claim 1 wherein said step of adjusting the administration of analgesia via clinical interpretation of PTT further comprises the step of:

if PTT decreases to less than a baseline value in response to surgical or procedural stimulation, then administering sufficient analgesia to increase PTT to greater than said baseline value.

12. The method of claim 7 wherein said predetermined time interval is 500 msec.

13. A system for noninvasively monitoring stress, pain or arousal in a subject comprising:

at least one ECG lead connected to a subject for acquiring ECG signals from said subject;

probe connected to a subject for acquiring pulse waveform signal from said subject;

a processor for analyzing said ECG and PPG signals to compute an estimate of said subject'"'"'s PTT from the heart of said subject to a location on the body of said subject where said PPG probe is attached and for determining whether the administration of analgesia needs to be adjusted based on said PTT.

14. The system for noninvasively monitoring stress, pain or arousal in a subject of claim 13 wherein said probe is a photoplethysmograph.

15. The system for noninvasively monitoring stress, pain or arousal in a subject of claim 13 wherein said probe is a tonometer device.

16. The system for noninvasively monitoring stress, pain or arousal in a subject of claim 13 wherein said probe is a an invasive arterial line.