N/A
N=40
Tetragraph® Monitor: Tolerance of Preoperative Placement
Surgery
Bottom Line
View on ClinicalTrials.gov: NCT05964166 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Tolerance to Preop Placement as Assessed by Likert Scale — 0; 10; 0; 10 units on a scale (0-10)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TetraGraph NMT Monitor (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Joseph D. Tobias
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerance to Preop Placement as Assessed by Likert Scale |
0; 10; 0; 10 | — |
| SECONDARY Application Ease |
4; 10 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05964166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.