Neurostimulation and Electromyographic Assessment of the TetraGraph (NEAT) In Patients (NEAT-3) (NEAT-3)

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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Hungary
  • Debrecen, Hungary, 4032
    • University of Debrecen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective surgeries requiring muscle relaxation

Description

Inclusion Criteria:

1. Age 18 years or older.
2. American Society of Anesthesiology (ASA) physical status I-III criteria (Table I).
3. Subject has provided written informed consent.

Exclusion Criteria:

1. Presence of an underlying neuromuscular disease.
2. Presence of renal or hepatic disease.
3. Subject has open skin sores in the locations needed for electrode application (forearms).
4. Patient is taking anti-seizure medication
5. Patient is taking oral anti-cholinesterase (e.g., therapy for myasthenia gravis)
6. Magnesium sulfate administration is required

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Elective surgery with muscle relaxation; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Acceptable levels of electrical noise when no stimulus is being applied;; Ensuring that the stimulus artifact does not obscure the EMG response when a stimulus is applied;; Appearance of an EMG response at threshold stimulation levels, just sufficient to elicit a palpable twitch response;; Consistency of the EMG response amplitudes during repeated (ST and TOF) protocols (variability <10%);; Consistency of EMG response characteristics independent of patient age, gender, or weight;; Consistency of EMG response characteristics independent whether the right or left arm is stimulated;; Skin reaction to stimulation or recording electrodes;; Overall usability of the device for clinicians and operators; collecting recommendations for improving ease of use.	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.	participants will be followed for the duration of hospital stay, an expected avarage of 5 days

Collaborators and Investigators

• Sponsor: University of Debrecen
• Investigators: Principal Investigator: Bela Fulesdi, MD,PhD,DSci, UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimate): September 16, 2014

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: electromyography; neuromuscular blockade
• Other Study ID Numbers: ADBV-ABS-0214-NEAT-3H; 028605/2014/OTIG (Registry Identifier: The Office for Health Authorization and Administrative Procedures (EEKH)); DE RKEB/IKEB 4170-2014 (Registry Identifier: Regional and Institutional Ethics Committee, Medical and Health Science Center, University of Debrecen)