Trial Outcomes & Findings for Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit (NCT NCT03920670)
NCT ID: NCT03920670
Last Updated: 2021-04-29
Results Overview
Train-of-four ratios is the ratio of the fourth muscle response to the first one.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
baseline, after 5 minutes, after + 10 minutes
Results posted on
2021-04-29
Participant Flow
Participant milestones
| Measure |
Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand
TetraGraph was placed on dominant hand, ToFscan (TS) was placed on non-dominant hand
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
|
ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand
ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
57
|
58
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand
TetraGraph was placed on dominant hand, ToFscan (TS) was placed on non-dominant hand
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
|
ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand
ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand
n=60 Participants
TetraGraph was placed on dominant hand, ToFscan was placed on non-dominant hand
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
|
ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand
n=60 Participants
ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 15.2 • n=60 Participants
|
55.6 years
STANDARD_DEVIATION 15.1 • n=60 Participants
|
55.6 years
STANDARD_DEVIATION 15.2 • n=120 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=60 Participants
|
38 Participants
n=60 Participants
|
74 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=60 Participants
|
22 Participants
n=60 Participants
|
46 Participants
n=120 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
60 participants
n=60 Participants
|
60 participants
n=60 Participants
|
120 participants
n=120 Participants
|
PRIMARY outcome
Timeframe: baseline, after 5 minutes, after + 10 minutesPopulation: Dominant arm Train-of-Four Ratios collected for analysis
Train-of-four ratios is the ratio of the fourth muscle response to the first one.
Outcome measures
| Measure |
Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand
n=57 Participants
TetraGraph was placed on dominant hand, ToFscan was placed on non-dominant hand
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
Dominant arm Train-of-Four Ratios collected for analysis
|
ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand
n=58 Participants
ToFscan was placed on dominant hand, TetraGraph (TG) was placed on non-dominant hand
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
Dominant arm Train-of-Four Ratios collected for analysis
|
|---|---|---|
|
Mean Train-of-Four Ratios (TOFR's)
baseline
|
0.97 Ratio
Standard Deviation 0.18
|
0.94 Ratio
Standard Deviation 0.13
|
|
Mean Train-of-Four Ratios (TOFR's)
after 5 minutes
|
0.96 Ratio
Standard Deviation 0.20
|
0.95 Ratio
Standard Deviation 0.12
|
|
Mean Train-of-Four Ratios (TOFR's)
after + 10 minutes
|
0.99 Ratio
Standard Deviation .014
|
0.94 Ratio
Standard Deviation 0.12
|
Adverse Events
Tetragraph (TG) Dominant Hand ToFscan (TS) Non-dominant Hand
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ToFscan (TS) Dominant Hand TetraGraph (TG) Non-dominant Hand
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place