NCT06458023

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

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Joseph D. Tobias · Academic / Other
• Sex: All
• Age: 1 Month – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-11
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-06-13
• Last updated: 2025-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study