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Trial Outcomes & Findings for Train-of-four Monitoring Using the Tetragraph (NCT NCT04475250)

NCT ID: NCT04475250

Last Updated: 2024-08-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

Immediately prior to start of surgery

Results posted on

2024-08-12

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
100
Overall Study
COMPLETED
100
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Train-of-four Monitoring Using the Tetragraph

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tetragraph
n=100 Participants
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.
Age, Categorical
<=18 years
100 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
11 years
STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male
Female
38 Participants
n=5 Participants
Sex: Female, Male
Male
62 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
97 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
Race (NIH/OMB)
White
90 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
4 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
100 participants
n=5 Participants
Weight
39.5 kilograms
STANDARD_DEVIATION 10.8 • n=5 Participants
Height
145 centimeters
STANDARD_DEVIATION 16 • n=5 Participants
Body mass index (BMI)
18.7 kg/m2
STANDARD_DEVIATION 3.3 • n=5 Participants

PRIMARY outcome

Timeframe: Immediately prior to start of surgery

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.

Outcome measures

Outcome measures
Measure
Tetragraph
n=100 Participants
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.
Baseline TOFr (%)
100.1 percent
Standard Deviation 8.4

PRIMARY outcome

Timeframe: At the end of surgery (maximum 7 hours from baseline)

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.

Outcome measures

Outcome measures
Measure
Tetragraph
n=100 Participants
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.
Recovered TOFr (%)
90.1 percent
Standard Deviation 13.1

SECONDARY outcome

Timeframe: Immediately prior to start of surgery

The amplitude of the muscle action potential prior to administration of the neuromuscular blocking agent.

Outcome measures

Outcome measures
Measure
Tetragraph
n=100 Participants
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.
Baseline Amplitude (mV)
7.5 millivolts
Standard Deviation 2.4

SECONDARY outcome

Timeframe: At the end of surgery (maximum 7 hours from baseline)

The amplitude of the muscle action potential after recovery from the neuromuscular blocking agent.

Outcome measures

Outcome measures
Measure
Tetragraph
n=100 Participants
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.
Recovered Amplitude (mV)
6.5 millivolts
Standard Deviation 2

SECONDARY outcome

Timeframe: At the end of surgery (maximum 7 hours from baseline)

The amount of time it took to return to a TOFr \>90% following reversal of neuromuscular blocking agent.

Outcome measures

Outcome measures
Measure
Tetragraph
n=100 Participants
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.
Rate of Muscle Recovery (Minutes)
2.6 minutes
Standard Deviation 1.4

Adverse Events

Tetragraph

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph D. Tobias, MD

Nationwide Children's Hospital

Phone: 614-722-4200

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place