Comparison of Two Quantitative EMG Monitors for Deep Neuromuscular Block in Laparoscopic/Robotic and VATS Surgery
9. července 2026 aktualizováno: Boris Mraovic, Ohio State University
Comparison of Two Quantitative Electromyography Monitors for Deep Neuro Muscular Block in Patients Undergoing Abdominal Laparoscopic/Robotic or Thoracic Video-Assisted (VATS) Surgeries
The main objective of the study is to compare the frequency of intraoperative spontaneous diaphragmatic movements and breath-initiation efforts in participants undergoing robotic and/or thoracic surgery under deep neuromuscular blockade (NMB), using either the TetraGraph or TwitchView applied to the dominant hand.
These events will serve as objective indicators to evaluate each device's ability to monitor and maintain adequate deep NMB.
Přehled studie
Postavení
Nábor
Podmínky
Detailní popis
This study is a prospective intraoperative device comparison trial evaluating neuromuscular blockade monitoring using two quantitative EMG-based devices, the TetraGraph (Senzime) and TwitchView (Blink), during elective laparoscopic, robotic, or video-assisted thoracoscopic (VATS) abdominal surgeries requiring neuromuscular blockade.
Participants will be assigned to receive both monitoring devices simultaneously, placed on opposite upper extremities, allowing each subject to serve as their own control.
Standard anesthesia care will be maintained throughout the procedure, including volatile anesthetic titration, opioid administration as needed, mechanical ventilation targeting normocapnia, temperature regulation, and routine neuromuscular blockade management with rocuronium and reversal with sugammadex per institutional practice.
Neuromuscular function will be continuously assessed using train-of-four (TOF), train-of-four ratio, and post-tetanic count (PTC) measurements, with data recorded at predefined intraoperative time points including baseline, post-paralytic administration, maintenance, reversal, and prior to extubation.
Additional data will include dosing of neuromuscular blocking agents, physiologic parameters, and intraoperative clinical observations relevant to depth of blockade and recovery.
Provider usability and workflow integration will be evaluated postoperatively through brief standardized surveys assessing device usability, signal quality, and overall satisfaction.
All collected data will be derived from device outputs and routine perioperative clinical documentation without altering standard patient care.
Typ studie
Intervenční
Zápis (Odhadovaný)
35
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Alberto Uribe, MD
- Telefonní číslo: 6142933559
- E-mail: alberto.uribe@Osumc.edu
Studijní záloha kontaktů
- Jméno: Elvia Vera, MD
- Telefonní číslo: 6142933559
- E-mail: Elvia.VeraMiquilena@osumc.edu
Studijní místa
-
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Ohio
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Columbus, Ohio, Spojené státy, 43201
- Nábor
- The Ohio State University Wexner Medical Center
-
Kontakt:
- Alberto Uribe, MD
- Telefonní číslo: 614-293-0775
- E-mail: alberto.uribe@osumc.edu
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
Inclusion Criteria:
- Adult male or female patients aged ≥ 18 years old.
- Patients undergo elective abdominal laparoscopic/robotic or thoracic video-assisted (VAT) surgeries requiring general anesthesia for greater than 3 hours at The Ohio State University Wexner Medical Center.
- Able to provide a signed, written informed consent.
- Able to speak, read, and write in English.
- ASA physical status I-III.
Exclusion Criteria:
- Patients who require emergency surgery or an emergent intervention.
- Any documented cognitive or psychological disorders that, in the investigator's opinion, can interfere with the patient's pain perception.
- Vulnerable populations: pregnant females, prisoners, breastfeeding.
- Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study (patients with pre-existing neuromuscular diseases.
- Allergy or contraindications to any of the anesthetics, NMB agents, or sugammadex.
- Patients with anatomical abnormalities of the hands or arms that prevent proper placement of the sensors for nerve stimulation.
- Limited access to the monitoring area due to surgical positioning.
- Patients with peripheral vascular disease, since it may affect measurement accuracy.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: TetraGraph (Senzime) Dominant Hand
Participants will have the TetraGraph (Senzime) electromyography (EMG) neuromuscular monitoring device placed on the dominant hand and the TwitchView (Blink) EMG neuromuscular monitoring device placed on the non-dominant hand.
The device placed on the dominant hand will be used to guide intraoperative neuromuscular blockade management, while measurements from both devices will be collected for comparison of quantitative neuromuscular monitoring performance.
|
The TetraGraph (Senzime) quantitative electromyography (EMG) neuromuscular monitoring device will be applied to the participant's dominant hand after induction of general anesthesia and prior to neuromuscular blocking agent administration.
Surface electrodes will be placed over the ulnar nerve per manufacturer instructions, and the device will be calibrated to obtain baseline Train-of-Four (TOF) measurements.
Following rocuronium administration, the device will continuously monitor neuromuscular function, recording TOF approximately every 15 seconds and post-tetanic count (PTC) every 5 minutes when TOF count is zero.
As the dominant-hand monitor, its readings will guide rocuronium redosing to maintain deep neuromuscular blockade (PTC 0-3) and assess recovery.
During emergence, it will guide reversal, with extubation at TOF ratio ≥0.9.
|
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Experimentální: TwitchView (Blink) Dominant Hand
Participants will have the TwitchView (Blink) electromyography (EMG) neuromuscular monitoring device placed on the dominant hand and the TetraGraph (Senzime) EMG neuromuscular monitoring device placed on the non-dominant hand.
The device placed on the dominant hand will be used to guide intraoperative neuromuscular blockade management, while measurements from both devices will be collected for comparison of quantitative neuromuscular monitoring performance.
|
The TwitchView (Blink) quantitative electromyography (EMG) neuromuscular monitoring device will be applied to the participant's dominant hand after induction of general anesthesia and prior to administration of neuromuscular blocking agents.
Surface electrodes will be placed over the ulnar nerve per manufacturer instructions, and the device will be calibrated to obtain baseline Train-of-Four (TOF) measurements.
Following rocuronium administration, neuromuscular function will be continuously monitored, with TOF recorded approximately every 15 seconds and post-tetanic count (PTC) every 5 minutes when TOF count is zero.
As the dominant-hand device, its measurements will guide rocuronium redosing to maintain deep neuromuscular blockade (PTC 0-3) and assess recovery.
During emergence, it will guide reversal, with extubation at TOF ratio ≥0.9.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of intraoperative diaphragmatic movement during deep neuromuscular blockade
Časové okno: During maintenance of deep neuromuscular blockade throughout the surgical procedure, from achievement of deep neuromuscular blockade after induction of general anesthesia until completion of surgery prior to emergence.
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The number of spontaneous diaphragmatic movement events observed during maintenance of deep neuromuscular blockade will be recorded and compared between participants monitored with the TetraGraph (Senzime) and TwitchView (Blink) electromyography (EMG) neuromuscular monitoring devices.
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During maintenance of deep neuromuscular blockade throughout the surgical procedure, from achievement of deep neuromuscular blockade after induction of general anesthesia until completion of surgery prior to emergence.
|
|
Incidence of spontaneous breath-initiation efforts during deep neuromuscular blockade
Časové okno: During maintenance of deep neuromuscular blockade throughout the surgical procedure, from achievement of deep neuromuscular blockade after induction of general anesthesia until completion of surgery prior to emergence.
|
The number of spontaneous breath-initiation efforts observed during maintenance of deep neuromuscular blockade will be recorded and compared between participants monitored with the TetraGraph (Senzime) and TwitchView (Blink) EMG neuromuscular monitoring devices.
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During maintenance of deep neuromuscular blockade throughout the surgical procedure, from achievement of deep neuromuscular blockade after induction of general anesthesia until completion of surgery prior to emergence.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Intubation Difficulty Scale (IDS) score
Časové okno: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
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Intubation difficulty will be assessed using the Intubation Difficulty Scale (IDS), a composite score ranging from 0 upward, where 0 represents easy intubation and higher scores indicate greater intubation difficulty.
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During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
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Incidence of patient movement or bucking during intubation
Časové okno: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
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Percentage of participants with patient movement or bucking during tracheal intubation, assessed as a clinical indicator of inadequate neuromuscular blockade.
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During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
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Cormack-Lehane grade of vocal cord visibility during intubation
Časové okno: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
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Vocal cord visibility will be assessed during tracheal intubation using the Cormack-Lehane laryngoscopic grading system (Grades I-IV), where Grade I indicates the best glottic view and Grade IV indicates the poorest view.
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During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
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Vocal cord movement during intubation
Časové okno: During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
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Vocal cord movement will be assessed during tracheal intubation using the predefined study classification (e.g., open, moving, closing, or closed) as an indicator of intubating conditions.
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During tracheal intubation following induction of general anesthesia and administration of neuromuscular blockade, prior to surgical incision.
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Post-tetanic count (PTC)
Časové okno: Throughout the intraoperative period during maintenance of neuromuscular blockade, from induction of general anesthesia until initiation of emergence from anesthesia.
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Post-tetanic count (PTC), reported as the number of muscle responses (count), will be measured using the TetraGraph and TwitchView neuromuscular monitoring devices and compared for agreement and correlation.
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Throughout the intraoperative period during maintenance of neuromuscular blockade, from induction of general anesthesia until initiation of emergence from anesthesia.
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Train-of-four (TOF) count
Časové okno: Throughout the intraoperative period during maintenance of neuromuscular blockade, from induction of general anesthesia until initiation of emergence from anesthesia.
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Train-of-four (TOF) count, reported as the number of twitch responses (0-4), will be measured using the TetraGraph and TwitchView devices and compared for agreement and correlation.
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Throughout the intraoperative period during maintenance of neuromuscular blockade, from induction of general anesthesia until initiation of emergence from anesthesia.
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Time to recovery of train-of-four ratio >0.9
Časové okno: During emergence from anesthesia, from administration of neuromuscular blockade reversal agent until extubation.
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Time, in minutes, from administration of neuromuscular blockade reversal agent to achievement of a train-of-four (TOF) ratio >0.9, as measured by the TetraGraph and TwitchView devices.
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During emergence from anesthesia, from administration of neuromuscular blockade reversal agent until extubation.
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Train-of-four ratio before extubation
Časové okno: Immediately before extubation following completion of surgery and recovery from neuromuscular blockade.
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Train-of-four (TOF) ratio, reported as a decimal value from 0 to 1.0 (or percentage), measured immediately before extubation using the TetraGraph and TwitchView devices.
Higher values indicate greater recovery of neuromuscular function.
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Immediately before extubation following completion of surgery and recovery from neuromuscular blockade.
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System Usability Scale (SUS) score
Časové okno: Immediately after completion of the intraoperative procedure and device use.
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Anesthesia care providers will evaluate device usability using the System Usability Scale (SUS), which ranges from 0 to 100, with higher scores indicating better perceived usability.
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Immediately after completion of the intraoperative procedure and device use.
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Leiden Surgical Rating Scale (L-SRS) score
Časové okno: At completion of the surgical procedure, prior to emergence from general anesthesia.
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Surgeon-rated surgical conditions will be assessed using the Leiden Surgical Rating Scale (L-SRS), a 5-point ordinal scale ranging from 1 to 5, where 1 indicates extremely poor surgical conditions and 5 indicates optimal surgical conditions.
Higher scores indicate better surgical conditions.
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At completion of the surgical procedure, prior to emergence from general anesthesia.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Kopman AF, Brull SJ. Etiology of Acceleromyographic Train-of-four Overshoot: A Hypothesis. Anesthesiology. 2025 Jun 1;142(6):1171-1173. doi: 10.1097/ALN.0000000000005377. Epub 2025 Apr 7. No abstract available.
- Blobner M, Frick CG, Stauble RB, Feussner H, Schaller SJ, Unterbuchner C, Lingg C, Geisler M, Fink H. Neuromuscular blockade improves surgical conditions (NISCO). Surg Endosc. 2015 Mar;29(3):627-36. doi: 10.1007/s00464-014-3711-7. Epub 2014 Aug 15.
- Ahluwalia JS, Morley CJ, Mockridge JN. Computerised determination of spontaneous inspiratory and expiratory times in premature neonates during intermittent positive pressure ventilation. II: Results from 20 babies. Arch Dis Child Fetal Neonatal Ed. 1994 Nov;71(3):F161-4. doi: 10.1136/fn.71.3.f161.
- Bussey L, Jelacic S, Togashi K, Hulvershorn J, Bowdle A. Train-of-four monitoring with the twitchview monitor electctromyograph compared to the GE NMT electromyograph and manual palpation. J Clin Monit Comput. 2021 Dec;35(6):1477-1483. doi: 10.1007/s10877-020-00615-7. Epub 2020 Nov 9.
- Matsuda K. [Mechanical properties of dental alloys for clasps]. Kokubyo Gakkai Zasshi. 1976 Jun;43(2):192. No abstract available. Japanese.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
9. února 2026
Primární dokončení (Odhadovaný)
9. února 2028
Dokončení studie (Odhadovaný)
9. srpna 2028
Termíny zápisu do studia
První předloženo
14. května 2026
První předloženo, které splnilo kritéria kontroly kvality
9. července 2026
První zveřejněno (Aktuální)
15. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
15. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. července 2026
Naposledy ověřeno
1. května 2026
Více informací
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