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Neuromuscular Monitoring Device

TetraGraph Monitoring for Infants Undergoing Surgery

N/A
Waitlist Available
Research Sponsored by Joseph D. Tobias
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing a surgical procedure with general anesthesia and requiring the administration of an NMBA
ASA 1-4
Must not have
Patients less than 28 days old
Patients with history of a peripheral neurologic or neuropathic disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare the effectiveness of a new monitoring device called TetraGraph in measuring muscle function in babies under 1 year old, to the traditional monitoring method.

Who is the study for?
This trial is for infants under 1 year old who are undergoing surgery. The study aims to include those who can safely undergo neuromuscular transmission monitoring during their procedure.
What is being tested?
The trial is testing the effectiveness of a device called TetraGraph in monitoring muscle response, known as train-of-four (TOF), during surgery in infants compared to standard TOF monitors when possible.
What are the potential side effects?
Since this trial involves non-invasive monitoring with the TetraGraph, there are no direct side effects from the device itself. However, general risks associated with surgical procedures and anesthesia apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having surgery that needs general anesthesia and muscle relaxants.
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My health is stable enough for surgery.
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I am 1 year old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a newborn, less than 28 days old.
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I have a history of nerve disorders.
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My upcoming surgery does not require muscle paralysis.
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I cannot use my arm for muscle strength tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
EMG changes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TetraGraph (TM) NMT MonitorExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Joseph D. TobiasLead Sponsor
22 Previous Clinical Trials
3,844 Total Patients Enrolled
6 Trials studying Surgery
522 Patients Enrolled for Surgery
~67 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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