An observational study in Neuromuscular Blockade, sponsored by University of Debrecen. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-28.
Sponsored by University of Debrecen · Observational
TetraGraph is a newly developed EMG-based, quantitative, battery-powered neuromuscular monitoring system intended for daily clinical use. The primary aim of this clinical investigation is to examine the applicability (ease of use, equipment need, etc.), repeatability (precision or internal consistency) and performance (signal quality, accuracy of outcome, voltage of stimulation output before and during a stimulus) of the Tetragraph device in patients undergoing elective surgeries requiring neuromuscular blockade.
The TetraGraph will be tested in 50 consenting patients undergiong elective surgeries requiring neuromuscular blockade. The left of right hand of the patients will be randomly studied. After the induction of anesthesia but before the administration of muscle relaxant train-of-four (TOF) stimulation will be started with 30 mA current intensity, 0.2 msec pulse duration at 20 sec intervals. The stimulation will be left to run until extubation. The TetraGraph device will be set not to show measurement results on the screen but save them on the SD card for later analysis. This way TetraGraph will not influence clinical decisions and patient care. During the operations we will record the number of muscle twitches in return to stimulation, the time and dose of muscle relaxant and opioid administration, the time of use of electrocautery and the skin temperature.
University of Debrecen is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing elective surgeries requiring muscle relaxation
Exclusion Criteria:
ASA I-II-III patients. Fentanyl (2-3 ug/kg) - Propofol (2 mg/kg) induction, sevoflurane anesthesia, type and dose of muscle relaxant up to the decision of attending anesthetist. Neuromuscular stimulation with TetraGraph (30mA current intensity, 0.2 msce pulse duration, 20 sec intervals)
Primary performance assessment of TetraGraph device
The primary objective of this study is to provide safety \& performance data of the TetraGraph device in anesthetized patients. Performance will be assessed post hoc by analyzing objective EMG data from the SD card and correlating the responses to annotations made during the surgical procedure (e.g., correlating the EMG responses to the time of NMBA or reversal agent administration). No clinical decisions will be made based on any objective measurements made by the TetraGraph. There are no specific timepoints concerning the primary outcome measure of the study.
Time frame: participants will be followed for the duration of their hospital stay, an expected avarage of five days
Secondary performance assessment of TetraGraph Device
The secondary outcome measures is a composite of several safety and performance data examined during the operations and the hospital stay: 1. Acceptable levels of electrical noise when no stimulus is being applied; 2. Ensuring that the stimulus artifact does not obscure the EMG response when a stimulus is applied; 3. Appearance of an EMG response at threshold stimulation levels, just sufficient to elicit a palpable twitch response; 4. Consistency of the EMG response amplitudes during repeated (ST and TOF) protocols (variability \<10%); 5. Consistency of EMG response characteristics independent of patient age, gender, or weight; 6. Consistency of EMG response characteristics independent whether the right or left arm is stimulated; 7. Skin reaction to stimulation or recording electrodes; 8. Overall usability of the device for clinicians and operators; collecting recommendations for improving ease of use.
Time frame: participants will be followed for the duration of the hospital stay, an expected avarage of 5 days
Safety of TetraGraph device
The safety of Tetragraph device will be assesses by checking the stimulating and recording electrode positions for skin reactions.
Time frame: participants will be followed for the duration of hospital stay, an expected avarage of 5 days
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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University of Debrecen