Electrophysiological Comparison of mAP and mADM Using EMG

March 6, 2019 updated by: J. Ross Renew, M.D., Mayo Clinic
The primary aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a blinded, single-center, prospective study in patients during surgery, requiring use of neuromuscular blockade. Neurostimulation will be used to monitor objective responses, as per current clinical routine. Data collection of Tetragraph EMG responses will be unavailable to the clinician for clinical decision-making, as per current clinical routine, but will be stored on the interfaced SD card.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population for this study includes patients receiving neuromuscular blocking agents during a surgical procedure.

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 verbal consent
  4. BMI <39

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. Patients on oral anticholinesterase, anti-seizure medications, and magnesium sulfate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary performance assessment of TetraGraph device
Time Frame: Duration of surgery
Agreement between the mAP and mADM EMG based TOF ratios
Duration of surgery
Primary performance assessment of TetraGraph device
Time Frame: Duration of surgery
Agreement between the mAP and mADM EMG based TOF counts
Duration of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary performance assessment of TetraGraph device
Time Frame: Duration of surgery
Correlation between stimulation current and T1 twitch height in the two muscles
Duration of surgery
Secondary performance assessment of TetraGraph device
Time Frame: Duration of surgery
Comparison of EMG to the quantitative AMG monitor
Duration of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: J R Renew, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Actual)

March 20, 2018

Study Completion (Actual)

March 20, 2018

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 17-006680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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