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New Indications for Peripheral Pulse Wave Acta Universitatis Tamperensis 2408 JARKKO HARJU New Indications for Peripheral Pulse Wave JARKKO HARJU New Indications for Peripheral Pulse Wave Acta Universitatis Tamperensis 2408 JARKKO HARJU New Indications for Peripheral Pulse Wave AUT 2408 AUT JARKKO HARJU New Indications for Peripheral Pulse Wave ACADEMIC DISSERTATION To be presented, with the permission of the Faculty Council of the Faculty of Medicine and Life Sciences of the University of Tampere, for public discussion in the auditorium of Finn-Medi 5, Biokatu 12, Tampere, on 14 September 2018, at 12 o’clock. UNIVERSITY OF TAMPERE JARKKO HARJU New Indications for Peripheral Pulse Wave Acta Universitatis Tamperensis 2408 Tampere University Press Tampere 2018 ACADEMIC DISSERTATION University of Tampere, Faculty of Medicine and Life Sciences Tampere University Hospital, Department of Anaesthesia Finland Supervised by Reviewed by Professor Arvi Yli-Hankala Docent Vesa Kontinen University of Tampere University of Turku Finland Finland Professor Niku Oksala Professor Tarmo Lipping University of Tampere Tampere University of Technology Finland Finland The originality of this thesis has been checked using the Turnitin OriginalityCheck service in accordance with the quality management system of the University of Tampere. Copyright ©2018 Tampere University Press and the author Cover design by Mikko Reinikka Acta Universitatis Tamperensis 2408 Acta Electronica Universitatis Tamperensis 1918 ISBN 978-952-03-0821-6 (print) ISBN 978-952-03-0822-3 (pdf) ISSN-L 1455-1616 ISSN 1456-954X ISSN 1455-1616 http://tampub.uta.fi Suomen Yliopistopaino Oy – Juvenes Print Tampere 2018 441 729 Painotuote To Eeva, Anna and Olli List of original publications This thesis is based on the following four original publications, referred to in the text by their Roman numerals (I-IV): I Matthias Gruenewald, M.*, Harju, J.*, Preckel, B., Molnár, Z., Yli- Hankala, A., Roßkopf, F., Koers, L., Orban, A., Bein, B. and the AoA- study Collaborators. Comparison of Adequacy of Anesthesia monitoring with standard clinical practice during routine general anesthesia: an international, multi-center, single-blinded RCT. Submitted II Harju, J., Kalliomaki, M.L., Leppikangas, H., Kiviharju, M. & Yli- Hankala, A. (2016). Surgical pleth index in children younger than 24 months of age: a randomized double-blinded trial, British journal of anaesthesia, 117(3), 358-364. III Harju, J., Vehkaoja, A., Kumpulainen, P., Campadello, S., Lindroos, V., Yli-Hankala, A. & Oksala, N. (2018). Comparison of non-invasive blood pressure monitoring using modified arterial applanation tonometry with intra-arterial measurement. Journal of Clinical Monitoring and Computing, 32(1), 13-22. IV Harju, J., Vehkaoja, A., Lindroos, V., Kumpulainen, P., Liuhanen, S., Yli-Hankala, A. & Oksala, N. (2017). Determination of saturation, heart rate, and respiratory rate at forearm using a Nellcor™ forehead SpO2- saturation sensor", Journal of Clinical Monitoring and Computing, 31(5), 1019-1026. *) Contributed equally The original publications are reprinted with the kind permission of the copyright holders. Abbreviations CO2 carbon dioxide BIS Bispectral index BSR Burst Suppression Ratio CI confidence interval CVI Composite variability index EEG electroencephalogram ECG electrocardiogram EMG electromyography ETAC end tidal anesthetic control HR heart rate ICU intensive care unit LoA limits of Agreement NIRS Near-infrared spectroscopy NMBA neuromuscular blocking agent NoL Nociception level MAC minimum alveolar concentration O2 oxygen ORI Oxygen Reserve Index PACU post anesthesia care unit PONV post-operative nausea and vomiting PPG photoplethysmography PPGA pulse photoplethysmographic amplitude PPGAnorm normalized pulse photoplethysmographic amplitude PVI Pleth variability index RE Response entropy RMSE root-mean-square-error RR respiratory rate RRI RR interval RRInorm normalized RR interval SD standard deviation SE State entropy SaO2 arterial oxygen saturation SpO2 arterial plethysmographic oxygen saturation SPI Surgical Ppleth Index StO2 tissue oxygen saturation SSI Surgical stress index TOF Train-of-four VAS Visual analogue scale Abstract The peripheral pulse wave contains a lot of important information that can be used in patient monitoring. It is easily accessible but contains several sources of potential error in measurement. The solutions using peripheral pulse wave include measurement of nociception, saturation, heart rate, respiratory rate and blood pressure among several other parameters. Surgical Pleth Index (SPI) is a novel algorithm for measuring intraoperative nociception. It combines the normalized plethysmographic amplitude and heart rate as one number indicating nociception and has been used intraoperatively to guide opioid administration. Although several studies have shown the reactivity of SPI to nociceptive stimulus, the evidence in guiding opioid administration is still scarce. Nor have such studies been accomplished on very small children. A typical site to measure SPI and other peripheral pulse wave parameters is the fingers. However, the measurement at the fingers is susceptible to artifacts caused by movement, vasoconstriction or hypothermia. A watch-like device at the distal forearm would offer a better and more convenient fixation for the measurements. Furthermore, there is some evidence that the forearm might be a better place for respiratory rate measurement using the same technology. There is at present no reliable method to measure blood pressure using plethysmography, but a wrist device with a tonometry sensor added would be one option to add that information, too. The aim of this thesis was to study new ways to utilize the peripheral pulse wave. The technologies used were plethysmography (Studies I, II and IV) and applanation tonometry (Study III) Study I was a randomized multi-center controlled trial with 494 patients. Patients were anesthetized using either standard monitoring (control group) or standard monitoring with additional monitoring of the depth of anesthesia (EntropyTM) and nociception (SPI) (test group). In this study we found no difference in the rate of signs of inadequate anesthesia. At the secondary endpoints, the time to eye-opening showed a trend in favor of the test group. In Study II the reactivity of the SPI was studied in thirty children aged less than two years. Children were randomized and double-blinded into two groups with either functional peripheral block or a placebo injection during surgery. SPI and its components were recorded blinded using a software and the time points of interest were analyzed post hoc. SPI was found to be reactive in small children and the reactivity was blunted by the use of peripheral local anesthetic block. However, the reactivity of SPI was rather small and there was marked inter-individual variability in reactions. The data for Studies III-IV was collected simultaneously. Thirty patients were monitored during postoperative care for two hours as an observation study. The data were collected using a study device attached around the distal forearm. Study III reported the measurement of non-invasive blood pressure using tonometry compared to invasive blood pressure monitoring. The blood pressure readings were found to be unacceptably inaccurate. Furthermore, the rate of failed measurements was rather high (22%). Factors affecting rate of failure consisted of movement and peripheral arterial disease. In Study IV the reliability of heart rate, respiratory rate, and saturation measurement at the distal forearm using a plethysmography sensor was compared to standard monitoring from finger plethysmography (saturation and heart rate) or impedance pneumography (respiratory rate). There was a small bias in heart rate, respiratory rate, and saturation measurements when compared to standard monitoring. However, the accuracy described by root-mean-square-error (RMSE) was unacceptably high for respiratory rate and saturation while heart rate was detected with good accuracy. Movement was associated with higher RMSE. In conclusion, the monitoring of SPI and Entropy was not associated with better management of anesthesia in a large multicenter study. Time to eye- opening was slightly shorter in the test group when compared to control group. In small children SPI seems to be similarly reactive as in adults in spite of wide inter-individual variability in reactions. A higher baseline and smaller amplitude of change when compared to adults suggest that a modification of the algorithm might be needed before introducing the index for use with small children. The measurement of blood pressure, heart rate, and saturation at the distal forearm was unacceptably inaccurate, while respiratory rate yielded slightly better results. Blood pressure measurement especially seems to be highly sensitive to movement, also at the distal forearm. Accuracy therefore needs to be improved before adopting the technologies for patient monitoring. Tiivistelmä Perifeerisen pulssiaallon sisältämää tietoa voidaan käyttää potilaan seurannassa monin tavoin. Pulssiaalto on helppo saada mitattua, mutta mittaaminen on altis useille virhelähteille. Mitattavia suureita ovat olleet muun muassa kipuärsyke, kudoshapetus, sydämen syke, hengitystaajuus, verenpaine sekä useat muut elintoiminnot. Surgical Pleth Index (SPI) on leikkauksen aikaisen kipuärsykkeen mittaamiseen tarkoitettu lukuarvo. Se yhdistää muutokset pulssiaallon suuruudessa sekä sykkeen vaihtelussa yhdeksi leikkauksen aikaista kipuärsykettä kuvaavaksi lukemaksi. Useissa tutkimuksissa on osoitettu
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