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

Joseph D. Tobias

Status: Active, not recruiting

Conditions: Surgery

Treatments: Device: TetraGraph (TM) NMT Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06458023

STUDY00004121

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

TetraGraph (TM) NMT Monitor

Experimental group

Description:

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.

Treatment:

Device: TetraGraph (TM) NMT Monitor