Train-of-four Monitoring Using the Tetragraph

Train-of-four Monitoring Using the Tetragraph Neuromuscular Transmission Monitor and Comparison to Standard (Visual) Train-of-four Assessment With a Peripheral Nerve Stimulator

This is a prospective study that will evaluate the feasibility of using the Tetragraph Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: Tetragraph (TM) NMT Monitor

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric patients requiring anesthetic care and use of neuromuscular blockade
• Weight range of 20 - 60 kg

Exclusion Criteria:

• Patients with history of a peripheral neurologic or neuropathic disorder
• Patients in whom the upper extremity cannot be used for TOF monitoring
• Patients undergoing a surgical procedure in which neuromuscular blockade is not required
• Edematous patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tetragraph	Device: Tetragraph (TM) NMT Monitor; TetraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline TOFr (%)	Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Baseline TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) prior to administration of the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A lower TOFr equals stronger neuromuscular block and more muscle paralysis.	Immediately prior to start of surgery
Recovered TOFr (%)	Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Recovered TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) after recovery from the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A TOFr greater than or equal to 90% indicates adequate recovery from the neuromuscular block.	At the end of surgery (maximum 7 hours from baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Amplitude (mV)	The amplitude of the muscle action potential prior to administration of the neuromuscular blocking agent.	Immediately prior to start of surgery
Recovered Amplitude (mV)	The amplitude of the muscle action potential after recovery from the neuromuscular blocking agent.	At the end of surgery (maximum 7 hours from baseline)
Rate of Muscle Recovery (Minutes)	The amount of time it took to return to a TOFr >90% following reversal of neuromuscular blocking agent.	At the end of surgery (maximum 7 hours from baseline)

Collaborators and Investigators

• Sponsor: Joseph D. Tobias

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00001075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No