NCT02241304|CompletedDMC
Neurostimulation and Electromyographic Assessment of the TetraGraph (NEAT) In Patients (NEAT-3)
NEAT-3
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NEAT-3
Sponsor study identifier
Secondary identifiers
REGISTRY · The Office for Health Authorization and Administrative Procedures (EEKH)
REGISTRY · Regional and Institutional Ethics Committee, Medical and Health Science Center, University of Debrecen
observational
50
1 country
1
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 8, 2014
Actual (reported)September 16, 2014
Actual (reported)December 2015
Actual (reported)December 2015
Actual (reported)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.
participants will be followed for the duration of their hospital stay, an expected avarage of five days
Secondary performance assessment of TetraGraph Device
participants will be followed for the duration of the hospital stay, an expected avarage of 5 days
Safety of TetraGraph device
participants will be followed for the duration of hospital stay, an expected avarage of 5 days
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)
Patients undergoing elective surgeries requiring muscle relaxation
University of Debrecen
Debrecen, 4032, Hungary
1. Gätke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Acta Anaesthesiol Scand 2002;46:207-13. 2. Berg H, Viby-Mogensen J, Roed J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Acta Anaesthesiol Scand 1997;41:1095-103. 3. Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Anesth Analg 2008;107:130-7. 4. Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Nisman M. Anesthesiology 2008;109:389-98. 5. Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Vender JS, Gray J, Landry E, Gupta DK. Anesthesiology 2011;115:946-54. 6. Murphy GS, Brull SJ. Anesth Analg 2010;111:120-8. 7. Hemmerling TM, Le N. Can J Anesth 2007;54: 58-72. 8. Gätke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Acta Anaesthesiol Scand 2002; 46: 207-13. 9. Brull SJ, Silverman DG. Anesth Analg 1993;77:352-5. 10. Grayling M, Sweeney BP. Anaesthesia 2007; 62:806-9. 11. Liang SS, Stewart PA, Phillips S. Anesth Analg 2013;117:373-9.
Bela Fulesdi, MD,PhD,DSci
UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032
50 participants (actual enrollment reported by the registry).
First Submitted
July 8, 2014
First Posted
September 16, 2014
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Deep Neuromuscular Blockade During Robotic Radical Prostatectomy
Contact the study team to confirm eligibility.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
January 28, 2016
Record last verified: 2016-01
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