Train-of-four Monitoring Using the Tetragraph

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475250
• Other study ID #: STUDY00001075
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: January 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective study that will evaluate the feasibility of using the Tetragraph Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Pediatric patients requiring anesthetic care and use of neuromuscular blockade

• Weight range of 20 - 60 kg

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Surgery

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