TetraGraph for Surgery

Overseen By Julie Rice-Weimer, RN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Joseph D. Tobias

Disqualifiers: Neurologic disorder, Edema, TIVA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the TetraGraph, a device that monitors muscle responses during surgery to better understand nerve function. Researchers aim to compare muscle responses between infants (28 days to 3 months old) and adolescents or older patients (12 years and above) during surgery. The trial seeks participants undergoing surgery with a specific type of anesthesia that doesn't require muscle relaxants. Individuals may qualify if the upper arm can be used for monitoring and there is no history of nerve disorders. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance surgical outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the TetraGraph device is safe for use in surgical patients?

Research has shown that the TetraGraph safely monitors muscle relaxation during surgeries. This tool measures muscle response to nerve signals, ensuring proper relaxation when needed.

Studies have confirmed that TetraGraph is as safe and effective as other standard methods for monitoring muscle relaxation. This device aids doctors in making informed decisions during surgeries, prioritizing safety.

Reports indicate that TetraGraph supports patient safety by providing clear and precise information about muscle relaxation. This accuracy helps doctors manage muscle control, reducing the risk of complications.

In summary, TetraGraph is safe for monitoring muscle relaxation in surgical settings. It is a trusted tool that ensures patient safety by providing doctors with the necessary information to manage nerve and muscle function effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The TetraGraph system is unique because it offers a cutting-edge approach to monitoring neuromuscular function during surgery, especially in infants and adolescents. Unlike traditional methods that rely on subjective assessments, TetraGraph uses advanced technology to provide real-time, objective data about the neuromuscular block, allowing for more precise management during surgeries. Researchers are excited about this system because it has the potential to improve surgical outcomes by enhancing the safety and effectiveness of neuromuscular blockade monitoring, ultimately leading to faster recovery times and reduced complications for young patients.

What evidence suggests that the TetraGraph is effective for neuromuscular transmission monitoring?

Research has shown that using tools like the TetraGraph during surgery can greatly improve outcomes. In surgeries where these tools were used, only 7.25% of patients developed new nerve problems afterward, compared to 15% in surgeries without them. This indicates fewer nerve issues occurred when these tools were employed. Studies also highlight improved nerve health, particularly in complex spine surgeries. Overall, these tools effectively spot potential problems during surgery, helping to prevent complications. Participants in this trial will be divided into two groups: infants aged 28 days to 3 months and adolescents/young adults aged 12 years or above, to evaluate the effectiveness of TetraGraph in these different age groups. ^{6 7 8 9 10}

Who Is on the Research Team?

Joseph D Tobias, MD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for newborns up to 3 months old and patients aged 12 or older who are undergoing surgery. The study aims to compare differences in muscle response between these age groups.

Inclusion Criteria

ASA 1-3 patients

I am either between 28 days and 3 months old or 12 years and older.

I am having surgery with a specific type of anesthesia that doesn’t need muscle relaxants.

Exclusion Criteria

I cannot use my arm for nerve function tests.

I have a history of nerve disorders.

I am receiving anesthesia through an IV for my procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Monitoring

Participants undergo surgery and are monitored using the TetraGraph™ Neuromuscular Transmission Monitor to evaluate neuromuscular transmission

During surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TetraGraph

Trial Overview The intervention being tested is the TetraGraph monitor, which measures muscle response during surgery to understand how neuromuscular transmission varies by age.

How Is the Trial Designed?

Group I: Infants Experimental Treatment 1 Intervention

Infants 28 days to 3 months old undergoing surgery.

Group II: Adolescents Active Control 1 Intervention

Adolescents/young adults 12 years of age or above undergoing surgery.

Who Is Running the Clinical Trial?

Joseph D. Tobias

Lead Sponsor

Trials

24

Recruited

4,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12293856/

A Systematic Review of Clinical Outcomes and Cost ... Conclusions: IONM significantly improves neurological outcomes in spinal surgery and is cost-effective in most clinical scenarios, particularly ...

2. jneurophysiologicalmonitoring.com jneurophysiologicalmonitoring.com/index.php/pub/article/view/75

A Systematic Review | J of Neurophysiological Monitoring Results: From 1,492 surgeries analyzed, 1,227 employed IONM, yielding a 7.25% postoperative neurological deficit rate compared to 15% in non- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1094715923007201

Intraoperative Neurophysiological Monitoring During ... Average VAS before surgery was reported at 7.51 (± 1.93) and after surgery at 3.63 (± 2.47). Falowski et al reported a similar reduction in NRS score of 52.2%, ...

4. atm.amegroups.org atm.amegroups.org/article/view/115989/html

New frontiers in intraoperative neurophysiologic monitoring Neurologic outcomes in a variety of spine surgery types are improved when IONM is used. For example, in complex spine surgery, such as scoliosis correction, ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/21925682231196514

Accuracy of Intraoperative Neuromonitoring in the ... These results indicate that all neuromonitoring modalities have diagnostic utility in successfully detecting impending or incident intraoperative neurologic ...

6. senzime.com senzime.com/en/press-releases/new-us-data-confirms-tetragraph-supports-clinical-decisions-and-assures-patient

New US data confirms that TetraGraph supports clinical ... The product is designed to meet the needs of monitoring physiological data during surgery of patients receiving general anesthesia and muscle ...

7. senzime.com senzime.com/en/tetragraph

TetraGraph Classic Quantitative monitoring of ... TetraGraph is a state-of-the-art quantitative TOF monitor, supporting your neuromuscular blockade management with precision from induction to recovery.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12429317/

Observational Cohort Study of TetraGraph® ... Background/Objectives: Current guidelines recommend objective neuromuscular monitoring to ensure patient safety during neuromuscular blockade.

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K220530.pdf

K220530 - Elisa Maldonado-Holmertz - accessdata.fda.gov Thus, the test data demonstrate that TetraGraph is at least as safe and effective in monitoring the relaxation of the patient when neuromuscular ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT04475250

Train-of-four Monitoring Using the Tetragraph This is a prospective study that will evaluate the feasibility of using the Tetragraph Neuromuscular Transmission Monitor in comparison to standard (visual) ...