Neuromuscular BlockadeNEAT-3NCT02241304

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

An observational study of Neuromuscular Blockade, run by University of Debrecen at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuromuscular Blockade
How many people: 50 participants
Where: 1 siteHungary
Study dates: Jul 2014to Dec 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients undergoing elective surgeries requiring muscle relaxation

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hungary1 site

University of Debrecen
Debrecen, 4032

Other trials in Hungary

About this study

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.

Read the 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.

Conditions: Neuromuscular Blockade
Keywords: electromyography, neuromuscular blockade

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02241304
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
The secondary outcome measures is a composite of several safety and performance data examined during the operations and the hospital stay:
1. Acceptable levels of electrical noise when no stimulus is being applied;
2. Ensuring that the stimulus artifact does not obscure the EMG response when a stimulus is applied;
3. Appearance of an EMG response at threshold stimulation levels, just sufficient to elicit a palpable twitch response;
4. Consistency of the EMG response amplitudes during repeated (ST and TOF) protocols (variability <10%);
5. Consistency of EMG response characteristics independent of patient age, gender, or weight;
6. Consistency of EMG response characteristics independent whether the right or left arm is stimulated;
7. Skin reaction to stimulation or recording electrodes;
8. Overall usability of the device for clinicians and operators; collecting recommendations for improving ease of use.
Measured: 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.
Measured: participants will be followed for the duration of hospital stay, an expected avarage of 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Dec 2015

First posted16 Sep 2014 (estimated)
Study startJul 2014
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02241304
Sponsor's protocol ID: ADBV-ABS-0214-NEAT-3H
Other IDs: 028605/2014/OTIG, DE RKEB/IKEB 4170-2014
Acronym: NEAT-3
Status last verified: Jan 2016
First submitted: 8 Jul 2014
Last updated: 28 Jan 2016
Results posted: No
Data monitoring committee: Yes

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
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Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
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The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
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All Neuromuscular Blockade trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurostimulation and Electromyographic Assessment of the TetraGraph (NEAT) In Patients (NEAT-3)
ClinicalTrials.gov ID: NCT02241304
Acronym / sponsor ID: NEAT-3 / ADBV-ABS-0214-NEAT-3H
Conditions: Neuromuscular Blockade
Keywords: electromyography, neuromuscular blockade
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of DebrecenUniversity, hospital or other
Study start: Jul 2014
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 16 Sep 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients undergoing elective surgeries requiring muscle relaxation

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Primary performance assessment of TetraGraph device
Time frame: participants will be followed for the duration of their hospital stay, an expected avarage of five days
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.

2 secondary outcomes

Secondary performance assessment of TetraGraph Device
Time frame: participants will be followed for the duration of the hospital stay, an expected avarage of 5 days
Safety of TetraGraph device
Time frame: participants will be followed for the duration of hospital stay, an expected avarage of 5 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
Background1. 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.

Related trials for Neuromuscular Blockade

Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bela Fulesdi, MD,PhD,DSci principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Neuromuscular Blockade, run by University of Debrecen at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary performance assessment of TetraGraph device (time frame: participants will be followed for the duration of their hospital stay, an expected avarage of five days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02241304, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.