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NCT06458023 Clinical Trial

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

Surgery Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06458023
Other study ID # STUDY00004121
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 10, 2024
Est. completion date December 31, 2025

Study information
Verified date June 2024
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Month to 12 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary EMG changes Changes in the amplitude of the evoked response of the muscles. During the surgery
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