NCT02630576

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

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

First Submitted

Initial submission to the registry

May 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

May 22, 2015

Last Update Submit

March 8, 2017

Conditions

ElectromyographyNeuromuscular Monitoring

Keywords

electromyographyneuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Secondary performance assessment of TetraGraph Device

    Subjects will be followed for the time of measurements an expected avarage of one hour

Other Outcomes (1)

  • Safety assessment of TetraGraph device

    Subjects will be followed for the time of measurements an expected avarage of one hour

Study Arms (4)

Men - Left Hand

EXPERIMENTAL

5 healthy male volunteers undergoing 4 types of neuromuscular stimulation protocols on the left hand

Device: Neuromuscular stimulation

Men - Right Hand

EXPERIMENTAL

5 healthy male volunteers undergoing 4 types of neuromuscular stimulation protocols on the right hand

Device: Neuromuscular stimulation

Women - Left Hand

EXPERIMENTAL

5 healthy female volunteers undergoing 4 types of neuromuscular stimulation protocols on the left hand

Device: Neuromuscular stimulation

Women - Right Hand

EXPERIMENTAL

5 healthy female volunteers undergoing 4 types of neuromuscular stimulation protocols on the right hand

Device: Neuromuscular stimulation

Interventions

Neuromuscular stimulationDEVICE

Single twitch and train-of-four stimulation protocols will be performed at the randomised side with growing current intensity

Men - Left HandMen - Right HandWomen - Left HandWomen - Right Hand

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Volunteer is American Society of Anesthesiology (ASA) physical status I-III (Tabl
  • Volunteer has provided written informed consent

You may not qualify if:

  • Presence of an underlying neuromuscular disease
  • Use of medications known to interfere with neuromuscular transmission
  • Presence of renal or hepatic disease
  • Subject has only one upper extremity
  • Subject has open sores at the skin sites needed for electrode application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Debrecen

Debrecen, 4032, Hungary

Location

Related Publications (10)

  • 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.

    PMID: 11942873BACKGROUND

  • 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.

    PMID: 16428537BACKGROUND

  • 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.

    PMID: 12456433BACKGROUND

  • Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.

    PMID: 18635478BACKGROUND

  • Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4.

    PMID: 20442260BACKGROUND

  • 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.

    PMID: 17197470BACKGROUND

  • 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.

    PMID: 8394051BACKGROUND

  • Grayling M, Sweeney BP. Recovery from neuromuscular blockade: a survey of practice. Anaesthesia. 2007 Aug;62(8):806-9. doi: 10.1111/j.1365-2044.2007.05101.x.

    PMID: 17635429BACKGROUND

  • 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.

    PMID: 18497614BACKGROUND

  • 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.

    PMID: 2160781BACKGROUND

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
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 22, 2015

First Posted

December 15, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

HU(1)