Study NCT03920670
Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
Submitted Date:  March 1, 2021 (v6)
Quality Control Review Has Not Concluded

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Open or close this module Study Identification
Unique Protocol ID: 18-011298
Brief Title: Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
Official Title: Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2021
Overall Status: Completed
Study Start: February 28, 2019
Primary Completion: November 30, 2020 [Actual]
Study Completion: November 30, 2020 [Actual]
First Submitted: February 13, 2019
First Submitted that
Met QC Criteria:
April 15, 2019
First Posted: April 19, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: March 26, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Mayo Clinic
Responsible Party: Principal Investigator
Investigator: J. Ross Renew, M.D.
Official Title: Principal Investigator
Affiliation: Mayo Clinic
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Residual Neuromuscular Blockade
Keywords: Neuromuscular Blockade
ToFscan
Tetragraph
AMG
EMG
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 120 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Study Officials: J Ross Renew, MD
Principal Investigator
Mayo Clinic
Locations: 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
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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. PubMed 30130260
Links: Description: Mayo Clinic Clinical Trials
Available IPD/Information:

Open or close this module Documents
Study Protocol and Statistical Analysis Plan
Document Date: October 11, 2019
Uploaded: 02/26/2021 13:49
File Name: Prot_SAP_000.pdf

Study Results
Open or close this module Participant Flow
Reporting Groups
Description
Tetragraph (TG)

TetraGraph was placed on dominant hand, ToFscan (TS) was placed on non-dominant hand

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 was measured.

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 was measured.

ToFscan (TS)

ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand

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 was measured.

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 was measured.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Information within the Participant Flow module appears inconsistent.
Overall Study
  Tetragraph (TG) ToFscan (TS)
Started 60 60
Completed 57 58
Not Completed 3 2
Reason Not Completed
Protocol Violation 2 2
Adverse Event 1 0
Open or close this module Baseline Characteristics
Reporting Groups
Description
Tetragraph (TG)

TetraGraph was placed on dominant hand, ToFscan was placed on non-dominant hand

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 was measured.

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 was measured.

ToFscan (TS)

ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand

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 was measured.

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 was measured.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Information here appears inconsistent with information in other parts of the record.
Baseline Measures
    Tetragraph (TG) ToFscan (TS) Total
Overall Number of Participants 60 60 120
Age, Continuous
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed60 Participants60 Participants120 Participants
55.5(15.2)55.6(15.1)55.6(15.2)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed60 Participants60 Participants120 Participants
Female36 60%38 63.33%74 61.67%
Male24 40%22 36.67%46 38.33%
Race and Ethnicity Not Collected [1]
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed60 Participants60 Participants120 Participants
0
 
[1]

Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.

Region of Enrollment
Measure Type: Number
Unit of measure: participants
Number Analyzed60 Participants60 Participants120 Participants
United States
6060120
Open or close this module Outcome Measures
1. Primary Outcome Measure:
Measure Title Mean Train-of-Four Ratios (TOFR's)
Measure Description Train-of-four ratios is the ratio of the fourth muscle response to the first one.
Time Frame baseline, after 5 minutes, after + 10 minutes
Analysis Population Description
[Not Specified]
Reporting Groups
Description
Tetragraph (TG)

TetraGraph was placed on dominant hand, ToFscan was placed on non-dominant hand

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 was measured.

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 was measured.

ToFscan (TS)

ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand

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 was measured.

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 was measured.

Measured Values
  Tetragraph (TG) ToFscan (TS)
Overall Number of Participants Analyzed 57 58
Mean Train-of-Four Ratios (TOFR's)
Measure Type: Mean (Standard Deviation)
Unit of Measure: Train-of-four ratios
baseline 0.97 (0.18) 0.94 (0.13)
after 5 minutes 0.96 (0.20) 0.95 (0.12)
after + 10 minutes 0.99 (.014) 0.94 (0.12)

Quality Control Review Comment provided by the National Library of Medicine:

  1. Information within the measure appears inconsistent.
  2. The measure does not appear to include sufficient information to understand how outcomes are measured and reported.
Open or close this module Reported Adverse Events
Time Frame Adverse events were collected from baseline to end of scan, for a total of approximately 10 minutes
Adverse Event Reporting Description [Not specified]
Reporting Groups
Description
Tetragraph (TG)

TetraGraph was placed on dominant hand, ToFscan was placed on non-dominant hand

TetraGraph (TG): AMG and EMG neuromuscular blockade monitoring. The TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.

ToFscan (TS): Neuromuscular transmission monitor. A measure of muscle relaxation on an anesthetized subjects. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.

ToFscan (TS)

ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand

TetraGraph (TG): AMG and EMG neuromuscular blockade monitoring. The TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.

ToFscan (TS): Neuromuscular transmission monitor. A measure of muscle relaxation on an anesthetized subjects. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.

Quality Control Review Comment provided by the National Library of Medicine:

  1. Information here appears inconsistent with information in other parts of the record.
All-Cause Mortality
  Tetragraph (TG) ToFscan (TS)
 Affected/At Risk (%)Affected/At Risk (%)
Total All-Cause Mortality 0 / 57 (0%)0 / 58 (0%)

Quality Control Review Comment provided by the National Library of Medicine:

  1. The number of participants at risk appears inconsistent with data here or in other parts of the record.
Serious Adverse Events
  Tetragraph (TG) ToFscan (TS)
 Affected/At Risk (%)Affected/At Risk (%)
Total 0 / 57 (0%)0 / 58 (0%)

Quality Control Review Comment provided by the National Library of Medicine:

  1. The number of participants at risk appears inconsistent with data here or in other parts of the record.
Other Adverse Events
Frequency Threshold Above Which Other Adverse Events are Reported: 0%
  Tetragraph (TG) ToFscan (TS)
 Affected/At Risk (%)Affected/At Risk (%)
Total 0 / 57 (0%)0 / 58 (0%)

Quality Control Review Comment provided by the National Library of Medicine:

  1. The number of participants at risk appears inconsistent with data here or in other parts of the record.
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact:
Name/Official Title: J. Ross Renew, M.D.
Organization: Mayo Clinic
Phone: 904-956-3328
Email: Renew.J@mayo.edu

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