Tetragraph® Monitor: Tolerance of Preoperative Placement

• Sponsor: Joseph D. Tobias (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05964166
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.1
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Device: TetraGraph NMT Monitor	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tetragraph® Monitor: Tolerance of Preoperative Placement
• Actual Study Start Date: May 31, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tetragraph	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. EMG changes [During surgery]

   Changes in the amplitude of the evoked response of the muscles.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Joseph D. Tobias

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joseph D. Tobias, Chief of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT05964166
• Other Study ID Numbers: STUDY00003295
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Jul 27, 2023