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出境医 / 临床实验 / Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit

Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit

Study Description
Brief Summary:
The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.

Condition or disease Intervention/treatment Phase
Residual Neuromuscular Blockade Device: TetraGraph (TG) Device: ToFscan (TS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
Actual Study Start Date : February 28, 2019
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : November 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Tetragraph (TG)
TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand
 Device: TetraGraph (TG)
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.

Device: ToFscan (TS)
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.
Active Comparator: ToFscan (TS)
ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand
 Device: TetraGraph (TG)
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.

Device: ToFscan (TS)
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.
Outcome Measures
Primary Outcome Measures :
  1. Mean Train-of-Four Ratios (TOFR's) [ Time Frame: baseline, after 5 minutes, after + 10 minutes ]
    Train-of-four ratios is the ratio of the fourth muscle response to the first one.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age > or = 18 years old
  • Patients willing to participate and provide an informed consent
  • Patients undergoing an elective surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively.

Exclusion Criteria

  • Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
  • Patients with systemic neuromuscular diseases such as myasthenia gravis
  • Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
Contacts and Locations

Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Hungary
University of Debrecen
Debrecen, Hungary, 4031
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: J Ross Renew, MD Mayo Clinic
Tracking Information
First Submitted Date  ICMJE February 13, 2019
First Posted Date  ICMJE April 19, 2019
Results First Submitted Date  ICMJE March 1, 2021
Results First Posted Date  ICMJE April 29, 2021
Last Update Posted Date April 29, 2021
Actual Study Start Date  ICMJE February 28, 2019
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2021) 		Mean Train-of-Four Ratios (TOFR's) [ Time Frame: baseline, after 5 minutes, after + 10 minutes ]
Train-of-four ratios is the ratio of the fourth muscle response to the first one.
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019) 		Consistency in values obtained by ToFscan and TetraGraph [ Time Frame: up to 10 hours postoperatively ]
Obtain ToFscan values and TetraGraph values simultaneously in the recovery period simultaneously.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • Number of patients with incomplete neuromuscular blockade reversal [ Time Frame: up to 10 hours postoperatively ]
    Identify patients who demonstrate TOF reading below 90% in the recovery period
  • Patient's reported discomfort with use of devices [ Time Frame: up to 10 hours postoperatively ]
    Number of patients reporting discomfort associated with use of either device
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
Official Title  ICMJE Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
Brief Summary The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Residual Neuromuscular Blockade
Intervention  ICMJE
  • Device: TetraGraph (TG)
    TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.
  • Device: ToFscan (TS)
    ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.
Study Arms  ICMJE
  • Experimental: Tetragraph (TG)
    TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand
    Interventions:
    • Device: TetraGraph (TG)
    • Device: ToFscan (TS)
  • Active Comparator: ToFscan (TS)
    ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand
    Interventions:
    • Device: TetraGraph (TG)
    • Device: ToFscan (TS)
Publications * Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur M, Benson J, Newmark RL, Maher CE. Comparison of the TOFscan and the TOF-Watch SX during Recovery of Neuromuscular Function. Anesthesiology. 2018 Nov;129(5):880-888. doi: 10.1097/ALN.0000000000002400.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2019) 		120
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2019) 		30
Actual Study Completion Date  ICMJE November 30, 2020
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Age > or = 18 years old
  • Patients willing to participate and provide an informed consent
  • Patients undergoing an elective surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively.

Exclusion Criteria

  • Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
  • Patients with systemic neuromuscular diseases such as myasthenia gravis
  • Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920670
Other Study ID Numbers  ICMJE 18-011298
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party J. Ross Renew, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: J Ross Renew, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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