Control and Automation in Anaesthesia

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H. Schwilden H. Stoeckel (Eds.)

Control and Automation in Anaesthesia

With 106 Figures and 24 Tables

Springer

Professor Dr.Dr.med. H. Schwilden Professor Dr.med. Dr.med. h.c. Stoeckel Universitat Bonn Klinik und Poliklinik £iir Anasthesiologie und spezielle Intensivmedizin Sigmund-Freud-Str. 25 53105 Bonn, Germany

ISBN-13 :978-3-642-79575-6 e-ISBN-13:978-3-642-79573-2 001: 10.1007/978-3-642-79573-2

Library of Congress Cataloging-in-Publication Data. Control and automation in anesthesia/[ edited byJ H. Schwilden, H. Stoeckel. p. cm. Includes bibliographical references and index. ISBN-13:978-3-642-79575-6 I. Anesthesia - Data processing - Congresses. 2. Anesthetics - Administration - Automatic control - Congresses. 3. Patient monitoring - Data processing - Congresses. 1. Schwilden, Helmut. II. Stoeckel, Horst, 1930- . [DNLM: I. Anesthesia - congresses. 2. Monitoring, Physiologic methods - congresses. 3. Signal Processing, Computer-Assisted - congresses. 4. Drug Delivery Systems -congresses. 5. Automatic Data Processing - congresses. WO 200 C764 1995J RD80.95.C66 1995 617.9'6'0285 - dc20 DNLMIDLC for Library of Congress 95-1211

This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broad­casting, reproduction on microfilm or in any other ways, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current version, and permission for use must always be obtained from Springer-Verlag. Violations are liable for prosecution under the German Copyright Law.

© Springer-Verlag Berlin Heidelberg 1995 Softcover reprint of the hardcover 1st edition 1995

The use of general descriptive names, registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use.

product liability: The publisher cannot guarantee the accuracy of any information about dosage and application contained in this book. In every individual case the user must check such information by consulting the relevant literature.

Typesetting: Best-set Typesetter Ltd., Hong Kong

SPIN: 10492356 19/3130/SPS - 5 4 3 2 1 0 - Printed on acid-free paper

Professor Dr.Dr.med. H. Schwilden Professor Dr.med. Dr.med. h.c. Stoeckel Universitat Bonn Klinik und Poliklinik £iir Anasthesiologie und spezielle Intensivmedizin Sigmund-Freud-Str. 25 53105 Bonn, Germany

ISBN-13 :978-3-642-79575-6 e-ISBN-13:978-3-642-79573-2 001: 10.1007/978-3-642-79573-2

Library of Congress Cataloging-in-Publication Data. Control and automation in anesthesia/[ edited byJ H. Schwilden, H. Stoeckel. p. cm. Includes bibliographical references and index. ISBN-13:978-3-642-79575-6 I. Anesthesia - Data processing - Congresses. 2. Anesthetics - Administration - Automatic control - Congresses. 3. Patient monitoring - Data processing - Congresses. 1. Schwilden, Helmut. II. Stoeckel, Horst, 1930- . [DNLM: I. Anesthesia - congresses. 2. Monitoring, Physiologic methods - congresses. 3. Signal Processing, Computer-Assisted - congresses. 4. Drug Delivery Systems -congresses. 5. Automatic Data Processing - congresses. WO 200 C764 1995J RD80.95.C66 1995 617.9'6'0285 - dc20 DNLMIDLC for Library of Congress 95-1211

This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broad­casting, reproduction on microfilm or in any other ways, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current version, and permission for use must always be obtained from Springer-Verlag. Violations are liable for prosecution under the German Copyright Law.

© Springer-Verlag Berlin Heidelberg 1995 Softcover reprint of the hardcover 1st edition 1995

The use of general descriptive names, registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use.

product liability: The publisher cannot guarantee the accuracy of any information about dosage and application contained in this book. In every individual case the user must check such information by consulting the relevant literature.

Typesetting: Best-set Typesetter Ltd., Hong Kong

SPIN: 10492356 19/3130/SPS - 5 4 3 2 1 0 - Printed on acid-free paper

Preface

This book records the presentations given at a workshop held in Bonn in May 1994. The aim of the meeting was to bring together scientists from various disciplines and clinicians to discuss within a group of experts the theoretical, medical, engineering, and regulatory aspects of automated control of therapeutic interventions in. anaesthesiology.

The meeting was considered a continuation of a preceding work­shop on "Quantitation, Modelling and Control in Anaesthesia" [1], which was held also in Bonn 10 years ago in May 1984. That workshop dealt with problems of how to quantitate concepts like anaesthetic depth, how to model anaesthetic drug disposition, how to link phar­macokinetics and pharmacodynamics, and how to use such concepts for the control of anaesthetic drug delivery. With respect to these topics the current proceedings have simultaneously both a broadened and a narrowed perspective. It is broadened in so far as the topics of the workshop did not focus exclusively on anaesthetic drugs and the control of their delivery, but did also discuss anaesthesia machine monitoring and patients therapeutic monitoring as well as control of blood pressure and artificial ventilation. The proceedings have nar­rowed the perspective insofar as they do not intensively discuss the processes of quantitation and modelling but presuppose them and give more room to control, especially automated control.

During the past 10 years informatics has tremendously expanded its knowledge and methods applicable to control problems. Of special interest to medicine and anaesthesiology are the developments of fuzzy logic and neuronal networks. Fuzzy logic may represent the right formalism to "calculate" with fuzzy variables as are common in a clinical setting and to support decision making under uncertainty. Neuronal networks represent an intensively investigated type of syn­thetic objects which have the ability to learn. They have been success­fully applied to quite a number of control problems. With respect to the management of anaesthesia, this methodology seems to be espe-

1. Stoeckel H (ed) (1985) Quantitation, modelling and control in anaesthesia. Thieme, Stuttgart

VI Preface

cially suited for the automated control of multiple input-multiple out­put systems, such as the simultaneous infusions of different agents controlling, for instance, simultaneously antinociception, vigilance, haemodynamic quantities and muscle relaxation. The organizers of the meeting had the impression that these two topics in conjunction with artificial intelligence and expert systems will be the very method­ology in designing future automated control systems. It was, therefore, decided to review these methodologies at the beginning of the meeting.

By definition, control requires the measurement or estimation of at least one quantity or variable which should be controlled. Such quantity is in general only a surrogate variable of the underlying pro­cess to be controlled. Instead of the EEG, the anaesthesiologists actu­ally would like to control anaesthetic depth; instead of endtidal CO2, he would like to control adequate artificial ventilation; and instead of monitoring the EMG for the abductor pollicis longus, he would like to control the muscle relaxation of the patient. Hence the evaluation and the assessment of the measured signal with respect to the actual pro­cess one would like to control is of special importance and provokes the essential question as to what can and what should be monitored for the control of what process. This question is discussed with respect to the anaesthesia machine as well as with respect to a patient's anaesthetic therapy.

The various modes and approaches to the control and automation of artificial ventilation and the control and automation of Lv. and inhalational anaesthetic drug delivery are presented and discussed in detail in Parts III-IV. As automatically controlled systems are entering clinical practice, the non-medical and non-engineering aspects of au­tomated control, namely the liability and the requirements with re­spect to technical, regulatory, manufacturer's and even ethical points of view, are becoming important. This is discussed in the final part of the book. The recent development of guidelines, laws and other state­ments of regulatory character give particular emphasis to this part.

We hope that the proceedings will contribute to the discussion on control and automation in medicine and, in particular, in anaesthesiology and may thus eventually contribute to an advance­ment in anaesthetic therapy.

Our sincere thanks go to the distinguished group of speakers, chairmen and discussants who made the excellent contributions and shared freely their deep knowledge, expertise and experience.

Bonn, September 1994 HELMUT SCHWILDEN

HORST STOECKEL

Contents

I General Methods of Control and Automation

Decision Support via Fuzzy Technology H.-J. ZIMMERMANN ........... . 3

Principles of Adaptive Neural Networks for Control R. ECKMILLER . . . . . . . . . . . . . . . . . . . . . . 11

Artificial Intelligence and Expert Systems D.M. GABA ................. . 22

II Assessment and Evaluation of Signals and Measurements

a) Anaesthesia Machine Monitoring

Which Monitoring Qualities Ensure Proper Machine Function? H. FRANKENBERGER .... . . . . . . . . . . . . . . . . . 39

Reliability, Testability, Alarms, and the Fail-Safe Concept J.S. GRAVENSTEIN. . . . . . . . . . . . . . . . . . . 47

The Differences Between Closed-circuit, Low-flow, and High-flow Breathing Systems: Controllability, Monitoring, and Engineering Aspects L.H.D.J. BOOIJ and J.G.C. LEROU ........... .

b) Therapeutic Monitoring of Patients

Does the EEG Measure Therapeutic Opioid Drug Effect? V. BILLARD and S.L. SHAFER. . . . . . . . . . . . . . .

Somatosensory Evoked Potentials: Objective Measures of Antinbciception in the Anaesthetized Patient? E. KOCHS ......................... .

60

79

96

VIII Contents

Do Auditory Evoked Potentials Assess Awareness? D. SCHWENDER, S. KLASING, C. MADLER, E. POPPEL, and K. PETER . . . . . . . . . . . . . . . . . . . . . .

Should Neuromuscular Transmission Be Monitored Routinely During Anaesthesia?

107

J. VIBy-MOGENSEN . . . . . . . . . . . . . . . . . . . . 119

III Control and Automation of Artificial Ventilation

Pulmonary Function and Ventilatory Patterns During Anaesthesia P. KONIG, F. DONALD, and P.M. SUTER ....

What Can and What Should Be Controlled During Artificial Ventilation?

127

H.J. BENDER. . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Closed-Loop Control of Artificial Ventilation D.R. WESTENSKOW .............. .

IV Control and Automation of Drug Delivery

a) Volatile Anaesthetics

Adaptive Closed-Loop Control of End-Tidal Concentrations of Volatile Agents

149

D.R. WESTENSKOW . . . . . . . . . . . . . . . . . . . 155

Fuzzy Control of Arterial Blood Pressure by Volatile Anaesthetics A.M. ZBINDEN, M. DERIGHETTI, S. PETERSEN, and P. FEIGENWINTER ............. .

Model-based Adaptive Control of Volatile Anaesthetics by Quantitative EEG

158

H. SCHWILDEN and J. SCHUTTLER. . . . . . . . . . . . . 163

b) Intravenous Anaesthetics

The Target of Control: Plasma Concentrations or Drug Effect P.S.A. GLASS. . . . . . . . . . . . . . . . . . . . . . . . . . .. 177

Open-Loop Control Systems and Their Performance for Intravenous Anaesthetics J.W. SEAR ....................... . 185

Contents IX

Feedback Control of Intravenous Anaesthetics by Quantitative EEG J. SCHUTTLER and H. SCHWILDEN ...... .

Adaptive Control of Intravenous Anaesthesia by Evoked Potentials G.N.C. KENNY and D.A. RAy .......... .

c) Neuromuscular Blocking Agents and Vasoactive Drugs New Drug-Delivery Devices

Model-based Adaptive Control of Neuromuscular Blocking Agents K.T. OLKKOLA ........... .

Supervisory Adaptive Control of Arterial Blood Pressure by Vasoactive Agents N. Ty SMITH, J.F. MARTIN, J. MANDEL, A.M. SCHNEIDER,

194

208

223

and M.L. QUINN. . . . . . . . . . . . . . . . . . . . . 234

New Drug-Delivery Devices for Volatile Anaesthetics E.-G. SCHARMER. . . . . . . . . . . . . . . . . . . . . 242

New Drug-Delivery Systems for Intravenous Anaesthetics P.S.A. GLASS, J.R. JACOBS, and T. QUILL. . . . . . . . . . . 252

V Nonmedical Aspects of Automated Control: Requirements and Liability for Automated Systems

The Technical Point of View U. BOVENKAMP and H. JUNKER

Regulatory Aspects E. TSCHOPE .....

The Manufacturer's Point of View B. HERMANRUD .......... .

265

269

273

Subject Index. . . . . . . . . . . . . . . . . . . . . . . . . .. 277

Contributors

Bender, H.J.

Billard, V.

Booij, L.H.D.J.

Bovenkamp, U.

Eckmiller, R.

Frankenberger, H.

Gaba, D.M.

Institut fUr Anasthesiologie und spezielle Intensivrnedizin Klinikum der Stadt Mannheim 68135 Mannheim, Germany

Anesthesiology Service (112A) Stanford University School of Medicine 3801 Miranda Avenue Palo Alto, CA 94304, USA

Department of Anaesthesia Critical, Intensive and Emergency Care Academisch Ziekenhuis Nijmegen Geert Grooteplein 10 6500 HB Nijmegen, The Netherlands

TOV -Rheinland Sicherheit und Umweltschutz GmbH Abt. Medizintechnik 51101 K61n, Germany

Institut fur Informatik VI Universitat Bonn R6merstr.164 53117 Bonn, Germany

Labor fur Biomedizinische Technik Fachhochschule Lubeck Stephensonstr. 3 23562 Lubeck, Germany

Anesthesiology Service, 112A Palo Alto V AMC 3801 Miranda Avenue Palo Alto, CA 94304, USA

XII Contributors

Glass, P .S.A.

Gravenstein, J .S.

Hermanrud, B.

Kenny, G.N.C.

Kochs, E.

Konig, P.

Olkkola, K.T.

Scharmer, E.-G.

Schuttler, J.

Department of Anesthesiology Duke University Medical Center Durham, NC 27710, USA

Department of Anesthesiology College of Medicine University of Florida 1600 SW Archer Road Gainsville, FL 32610-0254, USA

Siemens 16 Electronics Avenue Danvers, MA 01923, USA

Department of Anaesthesia Royal Infirmary 8-16 Alexandra Parade Glasgow G31 2ER, UK

Institut fUr Anasthesiologie Klinikum Rechts der Isar Technische Universitat Miinchen Ismaninger Str. 22 81675 Munich, Germany

Hopital Cantonal Universitaire de Geneve Department d' Anesthesiologie 24, rue Michelin-du-Crest 1211 Geneva 4, Switzerland

Department of Anaesthesia Helsinki University Central Hospital Haartmaninkatu 4 00290 Helsinki, Finland

Dragerwerk Aktiengesellschaft Produktbereich Anasthesie Moislinger Allee 53/55 23542 Lubeck, Germany

Klinik fUr Anasthesiologie und spezielle Intensivmedizin Universitat Bonn Sigmund-Freud-Str.25 53105 Bonn, Germany

Contributors XIII

Schwender, D. Institut fUr Anasthesiologie Klinikum GroBhadern Ludwig-Maximilians-U niversitat Marchioninistr. 15 81377 Munich, Germany

Schwilden, H. Klinik rur Anasthesiologie und spezielle Intensivmedizin Universitat Bonn Sigmund-Freud-Str.25 53105 Bonn, Germany

Sear, J.W. Nuffield Department of Anaesthetics Level I The John Radcliffe Hospital Hadington Oxford 0X3 9DU, UK

TschOpe, E. Institut rur Arzneimittel des Bundesgesundheitsamtes Seestr.l0 13353 Berlin, Germany

Ty Smith, N. Department of Anesthesia University of California 3350 La Jolla Village Drive San Diego, CA 92161, USA

Viby-Mogensen, J. Department of Anaesthesia University Hospital Rikhshospitalet 9 Blegdamsvej 2100 Copenhagen, Denmark

Westenskow, D.R. Department of Anesthesiology University of Utah 50 North Medical Drive Salt Lake City, UH 84132, USA

Zbinden, A.M. Institut rur Anasthesiologie und Intensivbehandlung Inselspital 3010 Bern, Switzerland

XIV Contributors

Zimmermann, H.-J. Institut fUr Wirtschaftswissenschaften Rheinisch-W estfalische Technische Hochschule Templergraben 64 52056 Aachen, Germany