TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age

April 21, 2026 updated by: Joseph D. Tobias

Train-of-four Monitoring Using the Tetragraph Neuromuscular Transmission Monitor and Comparison to Standard (Visual) Train-of-four Assessment With a Peripheral Nerve Stimulator in Patients Less Than 1 Year of Age.

The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in pediatric patients less than 1 year of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA 1-4
  • ≤ 1 year of age
  • undergoing a surgical procedure with general anesthesia and requiring the administration of an NMBA

Exclusion Criteria:

  • Patients less than 28 days old
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
TOFr (%)
Time Frame: During the surgery (1-3 hrs. avg.)
The Train of Four ratio (TOFr) is a quantitative measure used in anesthesia to assess the depth of neuromuscular blockade and recovery, calculated by dividing the amplitude of the fourth twitch by the first twitch after four 2-Hz stimuli. A TOF ratio is the standard threshold for safe extubation and indicates sufficient recovery from nondepolarizing agents. A TOF ratio >/= 90% is the standard threshold for safe extubation and indicates sufficient recovery from nondepolarizing agents.
During the surgery (1-3 hrs. avg.)
Amplitude
Time Frame: During the surgery (1-3 hrs. avg.)
The amplitude of the muscle action potential in response to electrical stimulation of its corresponding peripheral nerve.
During the surgery (1-3 hrs. avg.)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Muscle Recovery
Time Frame: Baseline, After reversal of neuromuscular blockade during surgery (avg of 1-3 hrs)
The amount of time from administration of neuromuscular blockade reversal agent to muscle recovery (TOFr >/= 90).
Baseline, After reversal of neuromuscular blockade during surgery (avg of 1-3 hrs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph D. Tobias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2024

Primary Completion (Actual)

September 4, 2024

Study Completion (Actual)

September 4, 2024

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00004121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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