NCT06458023

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 and when feasible to compare it to standard TOF monitoring using a qualitative monitor.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 11, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

June 10, 2024

Last Update Submit

August 19, 2025

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • EMG changes

    Changes in the amplitude of the evoked response of the muscles.

    During the surgery

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 MonitorDEVICE

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

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

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

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations

US(1)