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This is a prospective study that will evaluate the feasibility of using the Tetragraph Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetragraph | Experimental |
|
| 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 |
|---|---|---|
| Baseline TOFr (%) | Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Baseline TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) prior to administration of the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A lower TOFr equals stronger neuromuscular block and more muscle paralysis. | Immediately prior to start of surgery |
| Recovered TOFr (%) | Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Recovered TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) after recovery from the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A TOFr greater than or equal to 90% indicates adequate recovery from the neuromuscular block. | At the end of surgery (maximum 7 hours from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Amplitude (mV) | The amplitude of the muscle action potential prior to administration of the neuromuscular blocking agent. | Immediately prior to start of surgery |
| Recovered Amplitude (mV) |
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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 |
|---|---|---|---|
| 38885397 | Derived | Tobias JD, Epstein RH, Rice-Weimer J, Yemele Kitio SA, Brull SJ, Kalsotra S. Pediatric Intraoperative Electromyographic Responses at the Adductor Pollicis and Flexor Hallucis Brevis Muscles: A Prospective, Comparative Analysis. Anesth Analg. 2024 Jul 1;139(1):36-43. doi: 10.1213/ANE.0000000000006926. Epub 2024 Jun 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tetragraph | 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 | 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 |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Baseline TOFr (%) | Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Baseline TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) prior to administration of the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A lower TOFr equals stronger neuromuscular block and more muscle paralysis. | Posted | Mean | Standard Deviation | percent | Immediately prior to start 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 | 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 | |
|---|---|---|---|---|
| Joseph D. Tobias, MD | 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 | Nov 7, 2022 | Jun 20, 2024 | Prot_SAP_000.pdf |
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|
The amplitude of the muscle action potential after recovery from the neuromuscular blocking agent.
| At the end of surgery (maximum 7 hours from baseline) |
| Rate of Muscle Recovery (Minutes) | The amount of time it took to return to a TOFr >90% following reversal of neuromuscular blocking agent. | At the end of surgery (maximum 7 hours from baseline) |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kilograms |
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| Height | Mean | Standard Deviation | centimeters |
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| Body mass index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Recovered TOFr (%) | Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Recovered TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) after recovery from the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A TOFr greater than or equal to 90% indicates adequate recovery from the neuromuscular block. | Posted | Mean | Standard Deviation | percent | At the end of surgery (maximum 7 hours from baseline) |
|
|
|
| Secondary | Baseline Amplitude (mV) | The amplitude of the muscle action potential prior to administration of the neuromuscular blocking agent. | Posted | Mean | Standard Deviation | millivolts | Immediately prior to start of surgery |
|
|
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| Secondary | Recovered Amplitude (mV) | The amplitude of the muscle action potential after recovery from the neuromuscular blocking agent. | Posted | Mean | Standard Deviation | millivolts | At the end of surgery (maximum 7 hours from baseline) |
|
|
|
| Secondary | Rate of Muscle Recovery (Minutes) | The amount of time it took to return to a TOFr >90% following reversal of neuromuscular blocking agent. | Posted | Mean | Standard Deviation | minutes | At the end of surgery (maximum 7 hours from baseline) |
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| 0 |
| 100 |
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| 100 |
| 0 |
| 100 |
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