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

NCT06458023 | Completed Results FDA Device

• 1 other identifier: STUDY00004121
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (2)

• TOFr (%)

  The Train of Four ratio (TOFr) is a quantitative measure used in anesthesia to assess the depth of neuromuscular blockade and recovery, calculated by dividing the amplitude of the fourth twitch by the first twitch after four 2-Hz stimuli. A TOF ratio is the standard threshold for safe extubation and indicates sufficient recovery from nondepolarizing agents. A TOF ratio \>/= 90% is the standard threshold for safe extubation and indicates sufficient recovery from nondepolarizing agents.

  During the surgery (1-3 hrs. avg.)

• Amplitude

  The amplitude of the muscle action potential in response to electrical stimulation of its corresponding peripheral nerve.

  During the surgery (1-3 hrs. avg.)

Secondary Outcomes (1)

• Rate of Muscle Recovery

  Baseline, After reversal of neuromuscular blockade during surgery (avg of 1-3 hrs)

Study Arms (1)

TetraGraph (TM) NMT Monitor

EXPERIMENTAL

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.

Device: TetraGraph (TM) NMT Monitor

Interventions

TetraGraph (TM) NMT Monitor 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.

TetraGraph (TM) NMT Monitor

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA 1-4
• ≤ 1 year of age
• undergoing a surgical procedure with general anesthesia and requiring the administration of an NMBA

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph D. Tobias: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• Chaney A, Villalobos EE, Rice-Weimer J, Tobias JD. Intraoperative Electromyographic Monitoring in Children Less Than 1 Year of Age. Paediatr Anaesth. 2025 Nov;35(11):934-939. doi: 10.1111/pan.70043. Epub 2025 Aug 27.

  PMID: 40862479 DERIVED

Results Point of Contact

• Title: Dr. Joseph Tobias
• Organization: Nationwide Children's Hospital

Joseph.Tobias@nationwidechildrens.org

614-722-4200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: June 11, 2024
• Primary Completion: September 4, 2024
• Study Completion: September 4, 2024
• Last Updated: May 13, 2026
• Results First Posted: May 13, 2026

Record last verified: 2026-03

Locations

US (1)