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.
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
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.
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.
- 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 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.
- 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)
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
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
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.
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.
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
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
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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 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; AzTrials last refreshed its copy on 8 Nov 2026.