SurgeryNCT04475250

Train-of-four Monitoring Using the Tetragraph

A study testing Tetragraph (TM) NMT Monitor in people with Surgery, run by Joseph D. Tobias at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 2 to 18 years
Conditions the study is for: Surgery
What is being tested?: Tetragraph (TM) NMT Monitor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2021to 30 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Pediatric patients requiring anesthetic care and use of neuromuscular blockade
Weight range of 20 - 60 kg

Who cannot join

Patients with history of a peripheral neurologic or neuropathic disorder
Patients in whom the upper extremity cannot be used for TOF monitoring
Patients undergoing a surgical procedure in which neuromuscular blockade is not required
Edematous patients

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

Official title: Train-of-four Monitoring Using the Tetragraph Neuromuscular Transmission Monitor and Comparison to Standard (Visual) Train-of-four Assessment With a Peripheral Nerve Stimulator

Conditions: Surgery
Being tested: Tetragraph (TM) NMT Monitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tetragraph (TM) NMT MonitorDevice
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.

Study groups in NCT04475250
Study group	Role	What they receive
Tetragraph	Experimental	Not described Receives: Device: Tetragraph (TM) NMT Monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Baseline Amplitude (mV)
The amplitude of the muscle action potential prior to administration of the neuromuscular blocking agent.
Measured: Immediately prior to start of surgery
Recovered Amplitude (mV)
The amplitude of the muscle action potential after recovery from the neuromuscular blocking agent.
Measured: 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.
Measured: At the end of surgery (maximum 7 hours from baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202130 May 2023

First posted17 Jul 2020
Study start1 Feb 2021
Primary completion30 May 2023
Study completion30 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04475250
Sponsor's protocol ID: STUDY00001075
Status last verified: Aug 2024
First submitted: 13 Jul 2020
Last updated: 12 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 38885397

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Train-of-four Monitoring Using the Tetragraph Neuromuscular Transmission Monitor and Comparison to Standard (Visual) Train-of-four Assessment With a Peripheral Nerve Stimulator
ClinicalTrials.gov ID: NCT04475250
Acronym / sponsor ID: STUDY00001075
Conditions: Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Joseph D. TobiasUniversity, hospital or other
Study start: 1 Feb 2021 (actual)
Primary completion: 30 May 2023 (actual)
Study completion: 30 May 2023 (actual)
First posted: 17 Jul 2020 (actual)
Results: Posted 12 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tetragraph	Experimental	Device: Tetragraph (TM) NMT Monitor

Who may qualify

Ages: 2 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Pediatric patients requiring anesthetic care and use of neuromuscular blockade
Weight range of 20 - 60 kg

Key exclusion criteria (4 listed)

Patients with history of a peripheral neurologic or neuropathic disorder
Patients in whom the upper extremity cannot be used for TOF monitoring
Patients undergoing a surgical procedure in which neuromuscular blockade is not required
Edematous patients

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tetragraph (TM) NMT MonitorTetraGraph 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.	Device	Tetragraph

Primary outcome

Baseline TOFr (%)
Time frame: 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.
Recovered TOFr (%)
Time frame: 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.

3 secondary outcomes

Baseline Amplitude (mV)
Time frame: Immediately prior to start of surgery
Recovered Amplitude (mV)
Time frame: At the end of surgery (maximum 7 hours from baseline)
Rate of Muscle Recovery (Minutes)
Time frame: At the end of surgery (maximum 7 hours from baseline)

Results and safety

Results posted to the registry on 12 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tetragraph	100	100

Primary outcome: Baseline TOFr (%)

Time frame: Immediately prior to start of surgery. Mean (Standard Deviation). Unit: percent

Measure	Tetragraph n = 100
Value	100.1 (8.4)

Primary outcome: Recovered TOFr (%)

Time frame: At the end of surgery (maximum 7 hours from baseline). Mean (Standard Deviation). Unit: percent

Measure	Tetragraph n = 100
Value	90.1 (13.1)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tetragraph	0 of 100 (0%)	0 of 100 (0%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38885397Tobias 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.
Individual participant dataSharing planned: No

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Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tetragraph (TM) NMT Monitor in people with Surgery, run by Joseph D. Tobias at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline TOFr (%) (time frame: Immediately prior to start of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04475250, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.