closed-loop control of general anesthesia: “my clinical
TRANSCRIPT
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[email protected](1)-46-25-27-67
Service d’AnesthésieHôpital Foch Suresnes
France
Closed-Loop Control of General Anesthesia: “My Clinical Experience”
Ngai LIU, M.D.
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JAMA 1950, 144 (13)
50 patients, ETHER“Major Surgical procedures
varying age, both sexesWithout untoward effect “
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-Mortier/Struys: Anaesthesia 1998 “Closed-loop controlled administration of propofol using BIS” -Morley: Anaesthesia 2000 “Closed-loop control of anaesthesia: An assessment of the BIS…”-Struys: Anesthesiology 2001 “Comparison of closed-loop controlled administration of propofol..”-Leslie/Absalom: Anaesthesia 2002 “Closed-loop … colonoscopy using the BIS”-Absalom: Anesthesiology 2002 “Closed-loop control…under combined general and regional anesthesia”-Absalom : BJA 2003 “Closed-loop control of propofol using the BIS …minor surgery”-Ihmsen/ Naguib: BJA 2007 “Teletherapeutic drug administration by long distance closed-loop control of propofol”-Puri: Anaesth. Intensive Care 2007 “Closed-loop anaesthesia delivery system using bispectral index”-Haddad : IEEE Neural Network 2007 “Neural Network Adaptive Output Feedback …for Intraoperative Anesthesia
Feasibility of Feedback control of Propofol
During GA MaintenanceUsing the BIS monitor
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Proportional-Differential + TCI propofol (Schnider) + Feed-forward
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June 2006, pp 470-475
Prospective randomized study20 patients/group
Manual vs Automated induction
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We wanted to compare our closed-loop controller to the manual TCI Titration in varying conditions of routine clinical anesthesia. Including minor and major surgery.
The titration of remifentanil TCI during the surgical procedure was decided by the physician in charge of the patient in both groups.
End point : 40 < BIS < 60 during maintenance.
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Percentage BIS 40-6050
40
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20
10
0
161817
6
11
55
100908070605040302010
50
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20
10
0
46
21
12
3
1009080706040302010 50
70 ± 21 vs 89 ± 9, p = 0.0001
Adequate anesthesia was more frequent in the Closed-loop group
Manual (n=81) Closed-loop (n=83)
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Hypnosis
AnalgesiaHR, MAP, Pupillometry
Paralysis
Hypnotic
NMBA
Surgery
Opioid ?DynamicBalance
Gray Br Med J 1952
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Case report
Male 72 yearsHistory of coronary disease (CABG and Angioplasty)Beta-blocker
Tympanoplasty
General AnesthesiaClosed-loop
PropofolManual TCI of RemifentanilBolus of Atracurium
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Instability !Oscillation !
TI draping Incision Arousal
Remi (ng/ml) 6 4 8 12 14 16 20
Propofol Target
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Movement
Your hypothesis ?
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Anesthesia depth
Dynamic Balance between
Hypnosis and Analgesia
Poor Analgesia
BIS Instability (oscillation) !
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With a Closed-loop BIS-Propofol system, we obtain a stable level of hypnosis and the BIS can also reflect the degree of inhibition of response to noxious stimuli.
If BIS suddenly increases in response to noxious stimuli, this could be a deficit in the analgesic component of anesthesia, and this requires an increase of analgesia.
We have implemented a second closed-loop controller between Remifentanil and BIS using a Proportional-
differential algorithm
GA = LOC + Inhibition of noxious stimuliP. Glass Anesthesiology 1998, 88; 5-6T. Bouillon et al Anesthesiology 2004
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With a Closed-loop BIS-Propofol system, we obtain a stable level of hypnosis and the BIS can also reflect the degree of inhibition of response to noxious stimuli.
If BIS suddenly increases in response to noxious stimuli, this could be a deficit in the analgesic component of anesthesia, and this requires to increase analgesia.
We have implemented a second closed-loop controller between Remifentanil and BIS using a Proportional-
differential algorithm
GA = LOC + Inhibition of noxious stimuliP. Glass Anesthesiology 1998, 88; 5-6T. Bouillon et al Anesthesiology 2004
We learn from failureNot from success.
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Kidney Tx
0
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1 301 601 901 1201 1501 1801 2101 2401
Time (secondes)
Bis
grefferénale
Male 27 years, Kidney Transplantation, HTA
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Time (Seconds)
Bis
-1
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grefferénalepropofol
Male 27 years, Kidney Transplantation, HTA
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1 301 601 901 1201 1501 1801 2101 2401
Temps (en secondes)
Bis
-1
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grefferénalepropofol
Male 27 years, Kidney Transplantation, HTA
Incision Retractor
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Titre du graphique
0
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1 301 601 901 1201 1501 1801 2101 2401
Temps (en secondes)
Bis
0
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grefferénaleremifentanilpropofol
Male, Kidney Transplantation, HTA
Incision Retractor
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Propofol and Remifentanil guided solely by the BIS : Manual vs Closed-loop
• Prospective Randomized, MulticenterAfter informed consentEthical Committee and AFSSAPS approval
• Foch, Argenteuil, Angers, Besançon.• Manuel vs Dual-loop• 100 patients per group• End points
– Percentage 40-60– Movement, HD– Behavior of the controller during all types of surgery– ASA IV
A854 ASA Meeting Chicago 2006
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ASA Meeting Chicago 2006
Manual Dual-loop
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100 %908070605040302010
50
40
30
20
10
0
Number of patients
Dual-loop (n=83)
Manual (n=84)
Percentage of Time 40-60
71 % ± 19 vs 82 % ± 12 (p < 0.0001)
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State Entropy : irregularity (1-32 Hz) : Depth of hypnosis Response Entropy (1-47 Hz)
(RE-SE) represents (32-47 Hz) : Facial EMG activity or adequacy of anti-nociception
ASA MeetingSan Francisco
2007A 1881
Feedback control of
Propofol-SE
Remifentanil-(RE-SE)
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0
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1000
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Manual (n=31) Dual-loop (n=27)
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0 20 40 60 80 100 120 140 160 1800
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100
0 20 40 60 80 100 120 140 160 180 minutes
SE
RE
% of patients 50
100
0
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2D Graph 12
1 2
nom
bre
de m
odifi
catio
ns d
e ci
bles
/h
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80
100
40 < BIS < 60 BIS < 40 BIS > 60
Dual-loop in ICU, Prospective randomized study (E. Bourgeois SFAR 2007)
Manual (n=14) vs Dual-loop sedation (n=15)
% 67 ± 22 vs 38 % ± 21
50 % PropofolDual-loop Manual
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What did the Closed-loop controller teach me ?
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12:00:07 AM 12:05:12 AM 12:10:12 AM 12:15:12 AM 12:20:12 AM 12:25:12 AM 12:30:12 AM 12:36:07 AM 12:41:07 AM 12:46:07 AM 12:51:07 AM
Tim e
Entropy
BIS
Female 20 years, 1.70 m, 50 kg, PK SchniderClosed-loop propofol, Remi fixed (4 ng/ml)
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12:00:07 AM 12:05:12 AM 12:10:12 AM 12:15:12 AM 12:20:12 AM 12:25:12 AM 12:30:12 AM 12:36:07 AM 12:41:07 AM 12:46:07 AM 12:51:07 AM
Tim e
Entropy
BIS
Female 20 years, 1.70 m, 50 kg, PK SchniderClosed-loop propofol (1%), Remi fixed (4 ng/ml)
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12:00:07 AM 12:05:12 AM 12:10:12 AM 12:15:12 AM 12:20:12 AM 12:25:12 AM 12:30:12 AM 12:36:07 AM 12:41:07 AM 12:46:07 AM 12:51:07 AM
Tim e
Entropy
BIS
Female 20 years, 1.70 m, 50 kg, PK SchniderClosed-loop propofol, Remi fixed (4 ng/ml)
Piglet 22 Kg3 month !
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00:00:07 00:05:12 00:10:12 00:15:12 00:20:12 00:25:12 00:30:12 00:36:07 00:41:07 00:46:07 00:51:07
temps
EntropyBIS
Propofol 2 %
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9-years-old boy 25 kgGiant lobar emphysemaSpO2 = 85 % with 10 l/min O2
Dual-loop Propofol-RemifentanilInduction and MaintenanceIntrathecal morphineRight postero-lateral thoracotomyMiddle lobectomy Lower lobe atypical resection
Paediatr Anaesth. 2007 Sep;17(9):909-10.
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Closed-loop administration of propofol and remifentanil guided by the Bispectral Index for transsphenoidal surgery in a patient
with extreme gigantism
Age : 24Weight : 125 kgHeight : 2.48 m !
Blade # 6
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0
10
2030
40
50
60
7080
90
100Bis
Induction MaintenancePropofol 0.9 mg/kg 5.2 mg/kg/hRemifentanil 1.9 µg/kg 0.30 µg/kg/min
40-60 : 83 % < 40 : 15 % > 60 : 2 %GS : 23Extubation : 7 min
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Female, 69 years, 1.60 m, 85 kgAortic StenosisAortic valve repair
Bis
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0:00:00 0:05:11 0:10:22 0:15:33 0:20:44 0:25:55 0:31:06
Bis
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Female, 69 years, 1.60 m, 85 kgAortic StenosisAortic valve repair
0
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180
0:00:00 0:05:11 0:10:22 0:15:33 0:20:44 0:25:55 0:31:06
BisSys
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Female, 69 years, 1.60 m, 85 kgAortic StenosisAortic valve repair
0
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180
0:00:00 0:05:11 0:10:22 0:15:33 0:20:44 0:25:55 0:31:060
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BisSyspropofolremifentanil
Propofol : 0.8 mg/kgRemifentanil : 2.6 µg/kg
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Feedback controlContinuous Titration to effect
compensates for most of PK Errors !
ModelConcentration
Drug
Safety +++
The impact of the PK model in a controller is low
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BIS Propofol Concentration (ng/ml)
0 50 100 150 200 250 300 350 400 450 500
20
40
60
80
100
0,5
1,0
1,5
2,0
2,5
Minutes
Safety
Closed-loop controller during cardiac arrest
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BIS Propofol Concentration (ng/ml)
0 50 100 150 200 250 300 350 400 450 500
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0,5
1,0
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2,0
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Minutes
Safety
Closed-loop controller during cardiac arrest
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Conclusion
• Feasibility of Dual-loop• Reliable and safe
• Closed-loop controller could fundamentally change the practice of Anesthesia !!!
“The clinician will always hold the ultimate responsibility for patient safety”O’Hara Anesthesiology 92
[email protected] Service d’Anesthésie Hôpital Foch Suresnes
France
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Open loop TCI
Semi-closed loop TCI
Closed-loop
What is the best for the physician ?
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Emergence
0.0177 ± 4 10 ± 7Extubation Time (min)
pClosed-loop(n = 83)
Manual TCI (n = 81)
min
4035302520151050
1009080706050403020100
Manual TCI
Closed-loop group
Greater predictability and better planning of the recovery phase
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Prof. Manfred MORARI
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0
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1 721 1441 2161 2881 3601 4321 5041
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%<40 4%<45 23%>60 2%>70 0
%30 50 59%45 60 75%40 60 94
Norepinephrine (mg/h)
1 1.6 1.5 1 0.61
Main events Fibero TEEnursing nursing
Case male 59 y
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40-600
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Manual TCI
Closed-loop
%
<45 < 40 >60
Figure 3. Efficiency of the system during maintenance of anesthesia. 40 < BIS < 60 = percentage of time in which the BIS value was between 40 and 60 during the maintenance. BIS < 45 = percentage of time in which the Bispectral index (BIS) value was below 45. BIS < 40 = percentage of time in which the BIS value was below a value of 40. BIS > 60 = percentage of time in which the BIS value was greater a value of 60. Manual TCI: Manual TCI group guided by the BIS. Closed-loop: Closed-loop group. # p < 0.0001, ns: not significant.
##
#
Closed-loop Anesthesia decreases the incidence of Too Deep AnesthesiaWeldon Anesthesiology 2002 : A1097Lennmarken ASA 2003 : A303Monk, ASA 2004 : A1361
Prolonged deep anesthesia was associated with increased risk of one year mortality !