NCT02241304

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

July 8, 2014

Last Update Submit

January 27, 2016

Conditions

Neuromuscular Blockade

Keywords

electromyographyneuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective surgeries requiring muscle relaxation

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Debrecen

Debrecen, 4032, Hungary

Location

Related Publications (1)

  • 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.

    BACKGROUND

Study Officials

  • Bela Fulesdi, MD,PhD,DSci

    UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PHD

Study Record Dates

First Submitted

July 8, 2014

First Posted

September 16, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

HU(1)