TetraGraph Monitoring for Infants Undergoing Surgery

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Joseph D. Tobias

Must be taking: NMBAs

Disqualifiers: Under 28 days, Neurologic disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: During the surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the TetraGraph Monitor, to evaluate its effectiveness in tracking muscle recovery during surgery in babies under one year old. The goal is to determine if this device outperforms the usual methods for monitoring muscle recovery after anesthesia. Eligible participants are babies undergoing surgery with anesthesia affecting muscles and without nerve or muscle disorders. As an unphased trial, participation offers the chance to contribute to important research that could enhance surgical care for infants.

Will I have to stop taking my current medications?

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

What prior data suggests that the TetraGraph NMT Monitor is safe for infants undergoing surgery?

Research shows that the TetraGraph Neuromuscular Transmission (NMT) Monitor safely checks muscle function. This device helps doctors monitor muscle relaxation during surgery.

While specific safety data for using TetraGraph in infants is lacking, it has succeeded in other situations. Known for accurately managing muscle relaxation, it helps prevent lingering muscle weakness after surgery.

The technology in TetraGraph enhances surgical safety by providing doctors with precise information, crucial for infants. Although limited studies directly involve infants, the device's success in similar cases offers some reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The TetraGraph (TM) NMT Monitor is unique because it offers an EMG-based approach to monitoring neuromuscular function objectively and quantitatively. Unlike traditional methods that often rely on subjective assessments, TetraGraph provides precise data on the depth of neuromuscular block and recovery. This allows clinicians to ensure that muscle function has fully recovered before ending anesthesia, potentially reducing the risk of residual paralysis after surgery. Researchers are excited about this device because it can enhance patient safety and improve surgical outcomes for infants.

What evidence suggests that the TetraGraph NMT Monitor is effective for neuromuscular monitoring in infants?

Research has shown that the TetraGraph Neuromuscular Transmission Monitor, used by participants in this trial, performs effectively for children, including babies. It measures muscle signals to assess muscle function during surgery. This ensures proper recovery from a muscle relaxant used during surgery, which is crucial for safety. Specifically, a TOF (train-of-four) ratio of 90% or more indicates good recovery from the muscle relaxant. The TetraGraph's precise monitoring reduces the risk of lingering muscle weakness after surgery, making it especially valuable for young children. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for infants under 1 year old who are undergoing surgery. The study aims to include those who can safely undergo neuromuscular transmission monitoring during their procedure.

Inclusion Criteria

I am 1 year old or younger.

I am having surgery that needs general anesthesia and muscle relaxants.

My health is stable enough for surgery.

Exclusion Criteria

Edematous patients

I am a newborn, less than 28 days old.

I have a history of nerve disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor during surgery

During the surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TetraGraph (TM) NMT Monitor

Trial Overview The trial is testing the effectiveness of a device called TetraGraph in monitoring muscle response, known as train-of-four (TOF), during surgery in infants compared to standard TOF monitors when possible.

How Is the Trial Designed?

Group I: TetraGraph (TM) NMT Monitor Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Joseph D. Tobias

Lead Sponsor

Trials

24

Recruited

4,000+

Citations

1. withpower.com withpower.com/trial/phase-surgery-5-2024-6d272

TetraGraph Monitoring for Infants Undergoing Surgery The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11566562/

Neuromuscular blockade monitoring in pediatric patients - PMC The TetraSensTM sensor is indicated for pediatric patients younger than 8 years of age. It is able to monitor EMG-based neuromuscular ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pan.70043

Intraoperative Electromyographic Monitoring in Children ... The primary endpoint evaluated the efficacy and feasibility of using the TetraGraph EMG monitor in pediatric patients < 1 year of age. The ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04475250

Train-of-four Monitoring Using the Tetragraph A TOFr greater than or equal to 90% indicates adequate recovery from the neuromuscular block. At the end of surgery (maximum 7 hours from baseline). Secondary ...

5. senzime.com senzime.com/en/tetragraph

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

6. senzime.com senzime.com/en/pediatric

TetraGraph for pediatric EMG-based quantitative TOF monitoring enables safe and accurate neuromuscular block management for your most delicate patients.