Tetragraph® Monitor: Tolerance of Preoperative Placement

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Device: TetraGraph NMT Monitor

• Registration Number: NCT05964166
• Lead Sponsor: Joseph D. Tobias

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-31
• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-27
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Results First Submitted: 2024-08-12
• Results First Submitted QC: 2024-08-12
• Results First Posted: 2024-09-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tetragraph	TetraGraph NMT Monitor	-

Primary Outcome Measures

Name	Time	Method
Tolerance to Preop Placement as Assessed by Likert Scale	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 Outcome Measures

Name	Time	Method
Application Ease	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States