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| ID | Type | Description | Link |
|---|---|---|---|
| 028605-010/2014/OTIG | Registry Identifier | The Office for Health Authorization and Administrative Procedures (EEKH) | |
| DE RKEB/IKEB4170-2014 | Registry Identifier | Regional and Institutional Ethics Committee, university of Debrecen |
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TetraGraph is a newly developed EMG-based (electromyograph), 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) and tolerability of the Tetragraph device in healthy volunteers.
The primary endpoint will be assessment of the ability of the TetraGraph prototype to deliver neuro-stimulation, and assessment of the ability to acquire muscle action potentials and record these evoked responses on the SD-card. The study will be performed on healthy volunteers - 10 male and 10 female. Testing will be done at two separate stimulation/recording sites: ulnar nerve stimulation/abductor digiti minimi (ADM) muscle recording; and ulnar nerve stimulation/adductor pollices (AP) muscle recording. The side of testing (RIGHT vs. LEFT hand) will be determined a priori and randomly by the principal investigator, such that 10 volunteers each will be tested on the RIGHT and 10 on the LEFT hands. At each stimulating/recording site two stimulation protocols (single twitch stimulation and train-of-four stimulation) will be performed with growing current intensity (10-60 mA (milliAmps), in a 10 mA step-up fashion). Volunteers will rate the tolerability of each stimulation protocols on a visual analogue scale. EMG data will be recorded on the SD card and evaluated off-line.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men - Left Hand | Experimental | 5 healthy male volunteers undergoing 4 types of neuromuscular stimulation protocols on the left hand |
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| Men - Right Hand | Experimental | 5 healthy male volunteers undergoing 4 types of neuromuscular stimulation protocols on the right hand |
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| Women - Left Hand | Experimental | 5 healthy female volunteers undergoing 4 types of neuromuscular stimulation protocols on the left hand |
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| Women - Right Hand | Experimental | 5 healthy female volunteers undergoing 4 types of neuromuscular stimulation protocols on the right hand |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular stimulation | Device | Single twitch and train-of-four stimulation protocols will be performed at the randomised side with growing current intensity |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary performance assessment of TetraGraph device | The primary objective of this study is the assessment of the ability of the prototype to deliver neuro-stimulation, and assessment of the ability to acquire muscle action potentials and record these evoked responses on the SD-card. | Subjects will be followed for the time of measurements an expected avarage of one hour |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary performance assessment of TetraGraph Device | The secondary outcome measures is a composite of several performance data:
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| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment of TetraGraph device | The safety of Tetragraph device will be assesses by checking the stimulating and recording electrode positions for skin reactions and by establishing the discomfort, if any, associated with nerve stimulation in awake, un-medicated human volunteers. Assessment will be made using an 11-point visual analog score (VAS) scale, anchored with 0 (representing no distress) and 10 (representing the worst distress ever experienced) (Table I). These VAS scores will be compared to those reported in the literature. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bela Fulesdi, MD,PhD,DSci | UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Debrecen | Debrecen | 4032 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11942873 | Background | Gatke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Postoperative muscle paralysis after rocuronium: less residual block when acceleromyography is used. Acta Anaesthesiol Scand. 2002 Feb;46(2):207-13. doi: 10.1034/j.1399-6576.2002.460216.x. | |
| 16428537 | Background | Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T. Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg. 2006 Feb;102(2):426-9. doi: 10.1213/01.ane.0000195543.61123.1f. |
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| Subjects will be followed for the time of measurements an expected avarage of one hour |
| Subjects will be followed for the time of measurements an expected avarage of one hour |
| 12456433 | Background | Kim KS, Lew SH, Cho HY, Cheong MA. Residual paralysis induced by either vecuronium or rocuronium after reversal with pyridostigmine. Anesth Analg. 2002 Dec;95(6):1656-60, table of contents. doi: 10.1097/00000539-200212000-00033. |
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| 17197470 | Background | Hemmerling TM, Le N. Brief review: Neuromuscular monitoring: an update for the clinician. Can J Anaesth. 2007 Jan;54(1):58-72. doi: 10.1007/BF03021901. |
| 8394051 | Background | Brull SJ, Silverman DG. Visual and tactile assessment of neuromuscular fade. Anesth Analg. 1993 Aug;77(2):352-5. doi: 10.1213/00000539-199308000-00024. |
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| 18497614 | Background | Claudius C, Viby-Mogensen J. Acceleromyography for use in scientific and clinical practice: a systematic review of the evidence. Anesthesiology. 2008 Jun;108(6):1117-40. doi: 10.1097/ALN.0b013e318173f62f. |
| 2160781 | Background | Connelly NR, Silverman DG, O'Connor TZ, Brull SJ. Subjective responses to train-of-four and double burst stimulation in awake patients. Anesth Analg. 1990 Jun;70(6):650-3. doi: 10.1213/00000539-199006000-00012. |