SurgeryNCT06458023

TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age

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

The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in pediatric patients less than 1 year of age. Read more about this study

Who is it for?: Ages 1 month to 12 months
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: 50 participants
Where: 1 siteUnited States
Study dates: 11 Jun 2024to 4 Sep 2024
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 1 month to 12 months
All sexes
No healthy volunteers
Child

Who may be able to join

ASA 1-4
≤ 1 year of age
undergoing a surgical procedure with general anesthesia and requiring the administration of an NMBA

Who cannot join

Patients less than 28 days old
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 in Patients Less Than 1 Year of Age.

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 NCT06458023
Study group	Role	What they receive
TetraGraph (TM) NMT Monitor	Experimental	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. Receives: Device: TetraGraph (TM) NMT Monitor

What is being measured

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

TOFr (%)
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.
Measured: During the surgery (1-3 hrs. avg.)
Amplitude
The amplitude of the muscle action potential in response to electrical stimulation of its corresponding peripheral nerve.
Measured: During the surgery (1-3 hrs. avg.)

Secondary outcomes (1)

Rate of Muscle Recovery
The amount of time from administration of neuromuscular blockade reversal agent to muscle recovery (TOFr >/= 90).
Measured: Baseline, After reversal of neuromuscular blockade during surgery (avg of 1-3 hrs)

Timeline

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

11 Jun 20244 Sep 2024

First posted13 Jun 2024
Study start11 Jun 2024
Primary completion4 Sep 2024
Study completion4 Sep 2024

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: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06458023
Sponsor's protocol ID: STUDY00004121
Status last verified: Mar 2026
First submitted: 10 Jun 2024
Last updated: 13 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

Chaney A, Villalobos EE, Rice-Weimer J, Tobias JD. Intraoperative Electromyographic Monitoring in Children Less Than 1 Year of Age. Paediatr Anaesth. 2025 Nov;35(11):934-939. doi: 10.1111/pan.70043. Epub 2025 Aug 27.
PubMed 40862479

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

Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma

All Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2026. 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 in Patients Less Than 1 Year of Age.
ClinicalTrials.gov ID: NCT06458023
Acronym / sponsor ID: STUDY00004121
Conditions: Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Joseph D. TobiasUniversity, hospital or other
Study start: 11 Jun 2024 (actual)
Primary completion: 4 Sep 2024 (actual)
Study completion: 4 Sep 2024 (actual)
First posted: 13 Jun 2024 (actual)
Results: Posted 13 May 2026

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 (TM) NMT Monitor	Experimental	Device: 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.

Who may qualify

Ages: 1 month to 12 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

ASA 1-4
≤ 1 year of age
undergoing a surgical procedure with general anesthesia and requiring the administration of an NMBA

Key exclusion criteria (5 listed)

Patients less than 28 days old
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 (TM) NMT Monitor

Primary outcome

TOFr (%)
Time frame: 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.
Amplitude
Time frame: During the surgery (1-3 hrs. avg.)
The amplitude of the muscle action potential in response to electrical stimulation of its corresponding peripheral nerve.

1 secondary outcome

Rate of Muscle Recovery
Time frame: Baseline, After reversal of neuromuscular blockade during surgery (avg of 1-3 hrs)

Results and safety

Results posted to the registry on 13 May 2026, 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 (TM) NMT Monitor	50	49

Primary outcome: TOFr (%)

Time frame: During the surgery (1-3 hrs. avg.). Mean (Standard Deviation). Unit: percent

Measure	TetraGraph (TM) NMT Monitor n = 49
Baseline	99 (16.3)
Recovered (after reversal of neuromuscular blockade)	95 (10)

Primary outcome: Amplitude

Time frame: During the surgery (1-3 hrs. avg.). Mean (Standard Deviation). Unit: millivolts

Measure	TetraGraph (TM) NMT Monitor n = 49
Baseline	6.8 (2.2)
Recovered	4.7 (1.5)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day of surgery, 1 day. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TetraGraph (TM) NMT Monitor	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40862479Chaney A, Villalobos EE, Rice-Weimer J, Tobias JD. Intraoperative Electromyographic Monitoring in Children Less Than 1 Year of Age. Paediatr Anaesth. 2025 Nov;35(11):934-939. doi: 10.1111/pan.70043. Epub 2025 Aug 27.
Individual participant dataSharing planned: Undecided

Related trials for Surgery

Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma

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 3 inclusion and 5 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 13 May 2026. 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 13 May 2026). 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?

TOFr (%) (time frame: During the surgery (1-3 hrs. avg.)). 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 NCT06458023, 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 13 May 2026.