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OpenTrials
Completed

NCT Number: NCT05964166

Tetragraph® Monitor: Tolerance of Preoperative Placement

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.

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Key information

Conditions

Surgery

Age range

3 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Tolerance to Preop Placement as Assessed by Likert Scale

    Time frame: 30 mins. prior to surgery

    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.

Secondary outcomes

  1. Application Ease

    Time frame: 30 minutes prior to surgery

    The ease of preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor will be assessed by the research staff by using a 10-point Likert scale with 0=very difficult and 10=very easy.

Sponsors and collaborators

Lead sponsor

Joseph D. Tobias

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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