Trial Outcomes & Findings for TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age (NCT NCT06458023)
NCT ID: NCT06458023
Last Updated: 2026-05-13
Results Overview
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.
COMPLETED
NA
50 participants
During the surgery (1-3 hrs. avg.)
2026-05-13
Participant Flow
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.
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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50
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Overall Study
COMPLETED
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49
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Patient didn't receive neuromuscular blocking agent
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1
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Baseline Characteristics
TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age
Baseline characteristics by cohort
| Measure |
TetraGraph (TM) NMT Monitor
n=49 Participants
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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|---|---|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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44 Participants
n=1512 Participants
|
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Age, Continuous
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5.45 months
STANDARD_DEVIATION 2.67 • n=1512 Participants
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Sex: Female, Male
Female
|
21 Participants
n=1512 Participants
|
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Sex: Female, Male
Male
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28 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=1512 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=1512 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Black or African American
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4 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
White
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34 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=1512 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1512 Participants
|
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Region of Enrollment
United States
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49 participants
n=1512 Participants
|
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Weight
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3.1 kilograms
STANDARD_DEVIATION 1.83 • n=1512 Participants
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Participants per weight group
0 to <4 kg
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3 Participants
n=1512 Participants
|
|
Participants per weight group
4 to <6 kg
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20 Participants
n=1512 Participants
|
|
Participants per weight group
6 to <8 kg
|
16 Participants
n=1512 Participants
|
|
Participants per weight group
More than 8 kg
|
10 Participants
n=1512 Participants
|
PRIMARY outcome
Timeframe: During the surgery (1-3 hrs. avg.)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.
Outcome measures
| Measure |
TetraGraph (TM) NMT Monitor
n=49 Participants
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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|---|---|
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TOFr (%)
Baseline
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99 percent
Standard Deviation 16.3
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TOFr (%)
Recovered (after reversal of neuromuscular blockade)
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95 percent
Standard Deviation 10
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PRIMARY outcome
Timeframe: During the surgery (1-3 hrs. avg.)The amplitude of the muscle action potential in response to electrical stimulation of its corresponding peripheral nerve.
Outcome measures
| Measure |
TetraGraph (TM) NMT Monitor
n=49 Participants
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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|---|---|
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Amplitude
Baseline
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6.8 millivolts
Standard Deviation 2.2
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Amplitude
Recovered
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4.7 millivolts
Standard Deviation 1.5
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SECONDARY outcome
Timeframe: Baseline, After reversal of neuromuscular blockade during surgery (avg of 1-3 hrs)The amount of time from administration of neuromuscular blockade reversal agent to muscle recovery (TOFr \>/= 90).
Outcome measures
| Measure |
TetraGraph (TM) NMT Monitor
n=49 Participants
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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|---|---|
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Rate of Muscle Recovery
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2.7 minutes
Standard Deviation 1.4
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Adverse Events
TetraGraph (TM) NMT Monitor
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place