SurgeryNCT07133412
An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraph
A study testing TetraGraph in people with Surgery, run by Joseph D. Tobias at 1 site in United States.
Trial summary
The goal of this study is to use electromyography-based train-of-four monitoring (TetraGraph™ Neuromuscular Transmission Monitor) as a means of evaluating differences in neuromuscular transmission between infants ≤ 3 months of age and adolescent and older patients (≥ 12 years of age). Read more about this study
- Who is it for?
- Ages 28 days to 25 years
- Conditions the study is for
- Surgery
- What is being tested?
- TetraGraph
- 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
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 28 days to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA 1-3 patients
- Aged 28 days - 3 months or ≥ 12 years
- Undergoing a surgical procedure with a volatile-agent based anesthetic that does not require administration of a neuromuscular blocking agent
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 required
- Edematous patients
- Patients receiving total intravenous anesthesia (TIVA)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
Julie Rice-Weimer, RN, 614-355-3142, Julie.Rice-Weimer@nationwidechildrens.org
Joseph Tobias, MD
About this study
Official title: An Evaluation of the Neuromuscular Junction in Infants Using Train-of-four Monitoring With the TetraGraph™ Neuromuscular Transmission Monitor
The goal of this study is to use electromyography-based train-of-four monitoring (TetraGraph™ Neuromuscular Transmission Monitor) as a means of evaluating differences in neuromuscular transmission between infants ≤ 3 months of age and adolescent and older patients (≥ 12 years of age).
- Conditions
- Surgery
- Being tested
- TetraGraph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetraGraphDevice
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 group | Role | What they receive |
|---|---|---|
| Infants | Experimental | Infants 28 days to 3 months old undergoing surgery. Receives: Device: TetraGraph |
| Adolescents | Active comparator | Adolescents/young adults 12 years of age or above undergoing surgery. Receives: Device: TetraGraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude
Average amplitude of the evoked response of the muscles.
Measured: First 30 minutes of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph D. Tobias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph D Tobias, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133412
- Sponsor's protocol ID
- STUDY00005296
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Neuromuscular Junction in Infants Using Train-of-four Monitoring With the TetraGraph™ Neuromuscular Transmission Monitor
- ClinicalTrials.gov ID
- NCT07133412
- Acronym / sponsor ID
- STUDY00005296
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to use electromyography-based train-of-four monitoring (TetraGraph™ Neuromuscular Transmission Monitor) as a means of evaluating differences in neuromuscular transmission between infants ≤ 3 months of age and adolescent and older patients (≥ 12 years of age).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants | Experimental | Device: TetraGraphInfants 28 days to 3 months old undergoing surgery. |
| Adolescents | Active comparator | Device: TetraGraphAdolescents/young adults 12 years of age or above undergoing surgery. |
Who may qualify
- Ages
- 28 days to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- ASA 1-3 patients
- Aged 28 days - 3 months or ≥ 12 years
- Undergoing a surgical procedure with a volatile-agent based anesthetic that does not require administration of a neuromuscular blocking agent
Key exclusion criteria (5 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 required
- Edematous patients
- Patients receiving total intravenous anesthesia (TIVA)
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 |
|---|---|---|
| TetraGraphTetraGraph 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 | Adolescents, Infants |
Primary outcome
Amplitude
Time frame: First 30 minutes of surgery
Average amplitude of the evoked response of the muscles.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
Joseph D Tobias, MD principal investigator
Nationwide Children's Hospital
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 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: opening soon, as of the sponsor's last update on 9 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Rice-Weimer, RN (614-355-3142, julie.rice-weimer@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude (time frame: First 30 minutes of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.