NCT06792058

Comparative Study of TetraGraph and Mechanomiograph Neuromuscular Monitors in Clinical Settings

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: University of Debrecen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Neuromuscular monitoring plays a critical role in reducing postoperative residual neuromuscular blockade (PRNB), a significant risk factor for respiratory complications. Despite the availability of various monitoring techniques, the validation of newer devices remains an ongoing challenge. This study compares the performance of the electromyography (EMG)-based Tetragraph neuromuscular monitor with the gold standard mechanomyography (MMG) device, focusing on their accuracy and reliability in clinical settings. Methods: Twenty cases were conducted during general surgeries requiring neuromuscular relaxation. Ulnar nerve was stimulated via the Tetragraph which detected the compound muscle action potential (CMAP) of adductor pollicis muscle. Simultaneously on the same arm the isometric force of the same stimulated muscle was registrated by the MMG and displayed in the Labchart 8 program. Bland-Altman analysis was used to describe the agreement between devices during distinct phases of neuromuscular blockade. The primary endpoint of the study was the comparison of TOF values of MMG and EMG during induction. In recovery, two groups were made from TOFRs: below and above the recommended muscle recovery to exclude PRNB (TOFR≥90%) (Fuchs-Buder 2023). Additionally, in deeper neuromuscular blockade Train-of-Four Count (TOFC), and Post-Tetanic Count (PTC) values were also analysed.

Conditions

• Patients Undergoing General Anesthesia

Interventions

Type	Name	Description
DEVICE	Mechanomiograph: The "gold standard" of quantitative monitoring	The "gold standard" of quantitative monitoring is mechanomyography (MMG), which measures the force of contraction of the adductor pollicis muscle following ulnar nerve stimulation. MMG responses are accurate and reproducible. However, the complex and bulky devices are only suitable for research use, are not suitable for clinical use and are not commercially available.
DEVICE	Electromiograph	Another type of monitor is the electromyograph, which can be seen as an alternative to mechanomyography because of its accuracy. This technique measures muscle activity as a summation of the action potentials of muscle fibres. This activity is proportional to the strength of the muscle contraction. The most commonly innervated nerve is also the ulnar nerve, which innervates the abductor digiti minimi and the first dorsalis interosseus muscles. During the measurements, electrical signals from these muscles are detected. EMG has several advantages over other monitoring techniques. It does not require immobilisation of the hand, thumb immobility is not a problem, no preload is required, and hypothermia does not affect the hand as much as other neuromuscular monitors. The TetraGraph (Senzime AB, Sweden) is a portable EMG-based neuromuscular minitor for which the manufacturers received marketing approval from the U.S. Food and Drug Administration (FDA) in 2019.

Timeline

• Start date: 2024-01-02
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: Hungary

Regulatory

• FDA-regulated device study