Tetragraph® Monitor: Tolerance of Preoperative Placement

Surgery Clinical Trial

Official title:

Tetragraph® Monitor: Tolerance of Preoperative Placement

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05964166
• Other study ID #: STUDY00003295
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• TetraGraph NMT Monitor
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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	EMG changes	Changes in the amplitude of the evoked response of the muscles.	During surgery