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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TetraGraph (TM) NMT Monitor | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TetraGraph (TM) NMT Monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| TOFr (%) | The Train of Four ratio (TOFr) is a quantitative measure used in anesthesia to assess the depth of neuromuscular blockade and recovery, calculated by dividing the amplitude of the fourth twitch by the first twitch after four 2-Hz stimuli. A TOF ratio is the standard threshold for safe extubation and indicates sufficient recovery from nondepolarizing agents. A TOF ratio >/= 90% is the standard threshold for safe extubation and indicates sufficient recovery from nondepolarizing agents. | During the surgery (1-3 hrs. avg.) |
| Amplitude | The amplitude of the muscle action potential in response to electrical stimulation of its corresponding peripheral nerve. | During the surgery (1-3 hrs. avg.) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Muscle Recovery | The amount of time from administration of neuromuscular blockade reversal agent to muscle recovery (TOFr >/= 90). | Baseline, After reversal of neuromuscular blockade during surgery (avg of 1-3 hrs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40862479 | Derived | Chaney A, Villalobos EE, Rice-Weimer J, Tobias JD. Intraoperative Electromyographic Monitoring in Children Less Than 1 Year of Age. Paediatr Anaesth. 2025 Nov;35(11):934-939. doi: 10.1111/pan.70043. Epub 2025 Aug 27. |
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One subject was excluded from the study prior to the TetraGraph being placed because the surgeon decided a neuromuscular blocking agent was not required clinically to complete the surgery. All other subjects were placed in the TetraGraph group.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | TOFr (%) | The Train of Four ratio (TOFr) is a quantitative measure used in anesthesia to assess the depth of neuromuscular blockade and recovery, calculated by dividing the amplitude of the fourth twitch by the first twitch after four 2-Hz stimuli. A TOF ratio is the standard threshold for safe extubation and indicates sufficient recovery from nondepolarizing agents. A TOF ratio >/= 90% is the standard threshold for safe extubation and indicates sufficient recovery from nondepolarizing agents. | Posted | Mean | Standard Deviation | percent | During the surgery (1-3 hrs. avg.) |
|
Day of surgery, 1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Tobias | Nationwide Children's Hospital | 614-722-4200 | Joseph.Tobias@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2024 | Mar 31, 2026 | Prot_SAP_000.pdf |
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| months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilograms |
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| Participants per weight group | The number of participants in each weight group. | Count of Participants | Participants |
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| Primary | Amplitude | The amplitude of the muscle action potential in response to electrical stimulation of its corresponding peripheral nerve. | Posted | Mean | Standard Deviation | millivolts | During the surgery (1-3 hrs. avg.) |
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| Secondary | Rate of Muscle Recovery | The amount of time from administration of neuromuscular blockade reversal agent to muscle recovery (TOFr >/= 90). | Posted | Mean | Standard Deviation | minutes | Baseline, After reversal of neuromuscular blockade during surgery (avg of 1-3 hrs) |
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| 49 |
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| 49 |
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