Tetragraph® Monitor: Tolerance of Preoperative Placement

NCT05964166 | Completed Results FDA Device

• 1 other identifier: STUDY00003295
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, non-blinded, single arm study. The primary objective of this study is to evaluate the tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 12 years of age.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Tolerance to Preop Placement as Assessed by Likert Scale

  Patient's tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor will be assessed by using a 10-point Likert scale with 0=very badly/pulled sensor off and 10=very well/left sensor alone.

  30 mins. prior to surgery

Secondary Outcomes (1)

• Application Ease

  30 minutes prior to surgery

Study Arms (1)

Tetragraph

EXPERIMENTAL

Device: TetraGraph NMT Monitor

Interventions

TetraGraph 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

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients requiring anesthetic care and use of neuromuscular blockade
• Age ≤ 12 years
• ASA 1-4

You may not qualify if:

• History of a peripheral neurologic or neuropathic disorder
• Upper extremity cannot be used for TOF monitoring
• Undergoing a surgical procedure in which neuromuscular blockade is not required
• Patient is edematous
• Patients with significant behavioral or neurocognitive issues which affect behavior and impact the ability to place the sensor

Sponsors & Collaborators

• Joseph D. Tobias: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Results Point of Contact

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

Joseph.Tobias@nationwidechildrens.org

6147224200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 27, 2023
• Study Start: May 31, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 18, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)