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

NCT ID: NCT06458023

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-11

Study Completion Date

2025-12-31

Brief Summary

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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 and when feasible to compare it to standard TOF monitoring using a qualitative monitor.

Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TetraGraph (TM) NMT Monitor

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joseph D. Tobias

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Tobias

Chief, Dept. of Anesthesiology & Pain Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004121

Identifier Type: -

Identifier Source: org_study_id

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