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New muscle monitor tested in tiny infants: could make surgery safer?

NCT ID NCT06458023

Knowledge-focused Sponsor: Joseph D. Tobias Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study tested a new device called the TetraGraph, which measures muscle recovery during surgery using electrical signals, in 50 infants under 1 year old. The goal was to see if it works better than the standard visual check doctors use. If accurate, it could help doctors know exactly when it's safe to wake infants up from anesthesia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TetraGraph NMT Monitor (device)
What this could lead to
If successful, this could provide a more accurate way to monitor muscle recovery in very young infants during surgery, potentially improving safety.
What could go wrong
This is a small, completed study with only 50 infants, so results may not apply to all situations. The device's benefit over standard methods is still uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

Jun 2024

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 12 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Surgery

Contacts and locations

Locations

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

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