NCT04475250

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

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

July 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 12, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

2.3 years

First QC Date

July 13, 2020

Results QC Date

June 21, 2024

Last Update Submit

August 7, 2024

Conditions

Surgery

Outcome Measures

Primary Outcomes (2)

  • Baseline TOFr (%)

    Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Baseline TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) prior to administration of the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A lower TOFr equals stronger neuromuscular block and more muscle paralysis.

    Immediately prior to start of surgery

  • Recovered TOFr (%)

    Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Recovered TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) after recovery from the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A TOFr greater than or equal to 90% indicates adequate recovery from the neuromuscular block.

    At the end of surgery (maximum 7 hours from baseline)

Secondary Outcomes (3)

  • Baseline Amplitude (mV)

    Immediately prior to start of surgery

  • Recovered Amplitude (mV)

    At the end of surgery (maximum 7 hours from baseline)

  • Rate of Muscle Recovery (Minutes)

    At the end of surgery (maximum 7 hours from baseline)

Study Arms (1)

Tetragraph

EXPERIMENTAL
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

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pediatric patients requiring anesthetic care and use of neuromuscular blockade
  • Weight range of 20 - 60 kg

You may not qualify if:

  • 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

Related Publications (1)

  • Tobias JD, Epstein RH, Rice-Weimer J, Yemele Kitio SA, Brull SJ, Kalsotra S. Pediatric Intraoperative Electromyographic Responses at the Adductor Pollicis and Flexor Hallucis Brevis Muscles: A Prospective, Comparative Analysis. Anesth Analg. 2024 Jul 1;139(1):36-43. doi: 10.1213/ANE.0000000000006926. Epub 2024 Jun 17.

    PMID: 38885397DERIVED

Results Point of Contact

Title
Joseph D. Tobias, MD
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
Chairman, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 17, 2020

Study Start

February 1, 2021

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

August 12, 2024

Results First Posted

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)