TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age
Not Applicable
- Conditions
- Surgery
- Interventions
- Device: TetraGraph (TM) NMT Monitor
- Registration Number
- NCT06458023
- Lead Sponsor
- Joseph D. Tobias
- Brief Summary
The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in pediatric patients less than 1 year of age and when feasible to compare it to standard TOF monitoring using a qualitative monitor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- ASA 1-4
- ≤ 1 year of age
- undergoing a surgical procedure with general anesthesia and requiring the administration of an NMBA
Exclusion Criteria
- Patients less than 28 days old
- Patients with history of a peripheral neurologic or neuropathic disorder
- Patients in whom the upper extremity cannot be used for TOF monitoring
- Patients undergoing a surgical procedure in which neuromuscular blockade is not required
- Edematous patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TetraGraph (TM) NMT Monitor TetraGraph (TM) 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.
- Primary Outcome Measures
Name Time Method EMG changes During the surgery Changes in the amplitude of the evoked response of the muscles.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States