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• W2904366768 abstract "Editor—The TOF-Cuff® (RGB Medical Devices, Madrid, Spain) is a new neuromuscular monitoring device that consists of a modified blood pressure cuff with two electrodes on the inside. It overcomes some of the disadvantages of other neuromuscular monitoring devices. For instance, the TOF-Cuff can be used during surgical procedures where the arms need to be adducted alongside the patient's body, as the measurements do not require a free-moving thumb. However, the TOF-Cuff has thus far only been compared with mechanomyography (MMG).1Rodiera J. Serradell A. Alvarez-Gomez J.A. Aliaga L. The cuff method: a pilot study of a new method of monitoring neuromuscular function.Acta Anaesth Scand. 2005; 49: 1552-1558Crossref PubMed Scopus (12) Google Scholar, 2Veiga Ruiz G. Garcia Cayuela J. Orozco Montes J. Parreno Caparros M. Garcia Rojo B. Aguayo Albasini J.L. Monitoring intraoperative neuromuscular blockade and blood pressure with one device (TOF-Cuff): a comparative study with mechanomyography and invasive blood pressure.Rev Esp Anestesiol Reanim. 2017; 64: 560-567Crossref PubMed Scopus (14) Google Scholar We aim to provide additional validation by comparing it with electromyography (EMG; EMG-NMT module with CARESCAPE™ B450 monitor; General Electric, Helsinki, Finland) and acceleromyography (AMG; TOF-Watch® SX with Hand Adapter; Organon, Oss, The Netherlands). We present the combined data of two independent research protocols, both conducted from January to May 2018 at the Radboud University Medical Centre (Nijmegen, The Netherlands; TOF-Cuff vs AMG) and Leiden University Medical Centre (Leiden, The Netherlands; TOF-Cuff vs EMG). Both protocols were approved by local ethics committees (2017–3858; p17.049) and registered (NTR6913; NCT03117387). The combined publication was not pre-planned. However, because the protocols are very similar, we reasoned that combined publication of the data would increase the validity of the results. For both protocols, a necessary sample size of 15 subjects was calculated to detect a bias of 0.06 (alpha 0.05; beta 0.20). After written informed consent was obtained, 30 adult subjects with ASA physical status 1–3, who were scheduled for elective surgery with general anaesthesia with the use of a neuromuscular blocking agent, were included. Exclusion criteria included neuromuscular disease, diabetes mellitus, indication for rapid sequence induction, expected difficult intubation, pregnancy, and known allergy to rocuronium. The protocols had a non-interventional design. Consequently, all anaesthetic procedures were left at the discretion of the attending anaesthesiologist. Normothermia was maintained. The TOF-Cuff was placed with the electrodes at the medial bicipital groove on one of either upper arm (non-randomised). The EMG and AMG devices were connected to the ipsi- and contralateral extremity, respectively. For AMG, the preload Hand Adapter and fingers were fixated using adhesive tape, allowing the thumb to move freely. After induction of anaesthesia, but before administration of rocuronium, devices were calibrated using built-in automatic calibration modes (AutoPilot in TOF-Cuff) to ensure supramaximal stimulation. Pulse width was 0.2 ms by default. Stable train-of-four (TOF) recordings in all devices were verified and defined as a difference of <5% in three consecutive measurements. Paired measurements were recorded every 30–60 s during spontaneous recovery from neuromuscular block and normalised for baseline TOF ratio. Data acquisition ceased when sugammadex was administered. To avoid underestimating bias in the last part of the recovery phase, paired data were discarded after one of the devices reached a normalised TOF ratio of 1.0 because ultimately both devices will return to a TOF ratio of 1.0. Data were stored in electronic case record forms (Castor EDC, CIWIT B.V., www.castoredc.com). A total of 310 paired measurements were analysed. Subject characteristics were not significantly different between the two groups. The mean induction dose of rocuronium was 44.3 mg (standard deviation = 7.5) in Nijmegen and 45.6 mg (5.0) in Leiden. One subject was excluded because stable baseline measurements by TOF-watch SX could not be established. Three subjects were excluded because sugammadex was given early in the recovery phase resulting in insufficient data. All four subjects were replaced. Only sugammadex was used as reversal agent. Data were analysed using a modified Bland–Altman analysis for repeated measurements.3Olofsen E. Dahan A. Borsboom G. Drummond G. Improvements in the application and reporting of advanced Bland–Altman methods of comparison.J Clin Monit Comput. 2015; 29: 127-139Crossref PubMed Scopus (61) Google Scholar The bias [95% confidence interval (CI)] for the TOF-ratio range of 0–1 was 0.28 (0.20–0.37) and 0.30 (0.24–0.37) for TOF-Cuff minus EMG and TOF-Cuff minus AMG, respectively, with wide limits of agreement (LoA; Fig. 1). For TOF-ratio range of 0.8–1, bias was 0.31 (0.20–0.42) and 0.38 (0.29–0.48). The average time of recovery (95% CI) until a normalised TOF ratio >0.9 was 24.0 (10.9–37.1) min (EMG) and 25.3 (11.6–39.0) min (AMG) longer than with TOF-Cuff. Our study is the first to compare the TOF-Cuff with EMG and AMG. Two other studies used MMG as reference method and, similar to our data, both found that recovery from neuromuscular block measured by TOF-Cuff preceded MMG.1Rodiera J. Serradell A. Alvarez-Gomez J.A. Aliaga L. The cuff method: a pilot study of a new method of monitoring neuromuscular function.Acta Anaesth Scand. 2005; 49: 1552-1558Crossref PubMed Scopus (12) Google Scholar, 2Veiga Ruiz G. Garcia Cayuela J. Orozco Montes J. Parreno Caparros M. Garcia Rojo B. Aguayo Albasini J.L. Monitoring intraoperative neuromuscular blockade and blood pressure with one device (TOF-Cuff): a comparative study with mechanomyography and invasive blood pressure.Rev Esp Anestesiol Reanim. 2017; 64: 560-567Crossref PubMed Scopus (14) Google Scholar They did, however, find a much smaller bias. Rodiera and colleagues1Rodiera J. Serradell A. Alvarez-Gomez J.A. Aliaga L. The cuff method: a pilot study of a new method of monitoring neuromuscular function.Acta Anaesth Scand. 2005; 49: 1552-1558Crossref PubMed Scopus (12) Google Scholar found a bias of –0.04 (MMG minus TOF-Cuff, 95% CI –0.06 to –0.02, LoA –0.21 to 0.12) for a TOF ratio >0.70 in 40 adults and 20 children. Veiga Ruiz and colleagues2Veiga Ruiz G. Garcia Cayuela J. Orozco Montes J. Parreno Caparros M. Garcia Rojo B. Aguayo Albasini J.L. Monitoring intraoperative neuromuscular blockade and blood pressure with one device (TOF-Cuff): a comparative study with mechanomyography and invasive blood pressure.Rev Esp Anestesiol Reanim. 2017; 64: 560-567Crossref PubMed Scopus (14) Google Scholar included 32 adults and calculated a bias of 0.047 (TOF-Cuff minus MMG) by comparing TOF-Cuff TOF ratio >0.7 with MMG TOF ratio >0.9. However, we contend that this is not a sound comparison. Additionally, neostigmine or sugammadex was routinely used in both studies, which may have attenuated bias. Note that our results are in concordance with the preliminary results presented by another research group.4Sfeir Machado E. Dupuis-Lozeron E. Kely Barcelos G. Tramer M.R. Czarnetzki C. Comparison of the TOF-cuff monitor with the TOF watch SX monitor.An observational study. Euroanaesthesia, Copenhagen2018Google Scholar Similar to other alternative monitoring sites, such as the orbicularis oculi or corrugator supercilii muscles, our study shows that the upper arm muscles and the adductor pollicis muscle have different neuromuscular properties.5Larsen P.B. Gatke M.R. Fredensborg B.B. Berg H. Engbaek J. Viby-Mogensen J. Acceleromyography of the orbicularis oculi muscle: II. Comparing the orbicularis oculi and adductor pollicis muscles.Acta Anaesthesiol Scand. 2002; 46: 1131-1136Crossref PubMed Scopus (31) Google Scholar, 6Yamamoto S. Yamamoto Y. Kitajima O. Maeda T. Suzuki T. Reversal of neuromuscular block with sugammadex: a comparison of the corrugator supercilii and adductor pollicis muscles in a randomized dose–response study.Acta Anaesthesiol Scand. 2015; 59: 892-901Crossref PubMed Scopus (17) Google Scholar In general, central muscles such as the diaphragm have a faster onset and earlier recovery from block than peripheral muscles such as the adductor pollicis and upper airway muscles.7Hemmerling T.M. Donati F. Neuromuscular blockade at the larynx, the diaphragm and the corrugator supercilii muscle: a review.Can J Anaesth. 2003; 50: 779-794Crossref PubMed Scopus (79) Google Scholar Consequently, even shallow levels of residual block in these muscles attenuate upper airway patency and inhibit protective airway reflexes.8Eikermann M. Blobner M. Groeben H. et al.Postoperative upper airway obstruction after recovery of the train of four ratio of the adductor pollicis muscle from neuromuscular blockade.Anesth Analg. 2006; 102: 937-942Crossref PubMed Scopus (71) Google Scholar, 9Sundman E. Witt H. Olsson R. Ekberg O. Kuylenstierna R. Eriksson L.I. The incidence and mechanisms of pharyngeal and upper esophageal dysfunction in partially paralyzed humans: pharyngeal videoradiography and simultaneous manometry after atracurium.Anesthesiology. 2000; 92: 977-984Crossref PubMed Scopus (256) Google Scholar, 10Eriksson L.I. Sundman E. Olsson R. et al.Functional assessment of the pharynx at rest and during swallowing in partially paralyzed humans: simultaneous videomanometry and mechanomyography of awake human volunteers.Anesthesiology. 1997; 87: 1035-1043Crossref PubMed Scopus (346) Google Scholar Because there is a time lag between the recovery from neuromuscular block at the upper arm and AMG and EMG at the adductor pollicis, the latter devices are more appropriate to exclude the presence of residual neuromuscular block. Measurement of block at the upper arm could be a better estimate of block at central muscles such as the diaphragm and vocal cords. This opens interesting opportunities for future studies. In addition, the behaviour of the TOF-Cuff in the situation were neuromuscular reversal agents are routinely administered deserves further attention. Our data indicate that measurement of neuromuscular block at the muscles of the upper arm using the TOF-Cuff cannot be used interchangeably with measurements at the adductor pollicis using EMG or AMG. Recovery to a normalised TOF ratio of >0.9 took on average 25 min longer with EMG or AMG compared with the TOF-Cuff. Therefore, EMG and AMG are more appropriate to exclude residual neuromuscular block. Study design: PK, MB, CK-B, AD. Data collection: PK, MB, HJE, GH. Measurements: HJE, GH, CM, AD. Statistical analysis: PK, MB, HJE, EO, GH. Interpretation of data: GH, PK, CM, MB, AD. Writing of the manuscript: PK, MB. Revision of the manuscript: HJE, CK-B, GJS, EO, GH, CM, AD. Discussed the results and contributed to the final manuscript: all authors. MB, AD and CM received consultancy, speaker fees, or both, from MSD. CK-B and PK received speaker fees from MSD. The investigator initiated trial in the Leiden University Medical Centre was partly supported by MSD Nederland BV through a MISP grant to AD." @default.
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• W2904366768 title "Comparison of the TOF-Cuff® monitor with electromyography and acceleromyography during recovery from neuromuscular block" @default.
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