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

NCT03920670 | Completed Results FDA Device

• 1 other identifier: 18-011298
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 3

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.

Conditions

Residual Neuromuscular Blockade

Keywords

Neuromuscular Blockade; ToFscan; Tetragraph; AMG; EMG

Outcome Measures

Primary Outcomes (1)

• Mean Train-of-Four Ratios (TOFR's)

  Train-of-four ratios is the ratio of the fourth muscle response to the first one.

  baseline, after 5 minutes, after + 10 minutes

Study Arms (2)

Tetragraph (TG)

EXPERIMENTAL

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

Device: TetraGraph (TG); Device: ToFscan (TS)

ToFscan (TS)

ACTIVE COMPARATOR

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

Device: TetraGraph (TG); Device: ToFscan (TS)

Interventions

TetraGraph (TG) DEVICE

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.

Tetragraph (TG); ToFscan (TS)

ToFscan (TS) DEVICE

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.

Tetragraph (TG); ToFscan (TS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

University of Debrecen

Debrecen, 4031, Hungary

Location

Related Publications (1)

• 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.

  PMID: 30130260 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: J. Ross Renew, M.D.
• Organization: Mayo Clinic

Renew.J@mayo.edu

904-956-3328

Study Officials

• J Ross Renew, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: April 19, 2019
• Study Start: February 28, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: April 29, 2021
• Results First Posted: April 29, 2021

Record last verified: 2021-03

Locations

US (2); HU (1)