Tetragraph® Monitor: Tolerance of Preoperative Placement

Joseph D. Tobias

Status: Completed

Conditions: Surgery

Treatments: Device: TetraGraph NMT Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05964166

STUDY00003295

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 3 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Tetragraph

Experimental group

Treatment:

Device: TetraGraph NMT Monitor