Clinical Application of "Train of Four" Testing in the Intraoperative Monitoring Setting

October 26, 2015 updated by: NYU Langone Health

Clinical Application of Train of Four Testing in the Intraoperative Monitoring Setting

The study examines the clinical application of TOF (train of four test) used by anesthesiologists and neurophysiologists during instrumented spine procedures, as well as certain associated parameters. 'Train of four' test is a test routinely used during the surgery, which is performed by stimulation of peripheral nerve with purpose to determine the degree of muscle relaxation by interpretation of muscle response. During spine surgery, it is helpful for the surgeon to have a patient's muscles as relaxed as possible with the least amount of tone, especially when exposing. Anesthesiologists achieve this level of relaxation by giving a neuromuscular blocking agent. If medication given to do this has not fully left their system by the time the surgeon needs to start putting in the screws and rods, then the intraoperative monitoring can not be adequately performed. If the muscles are too relaxed, then free run EMG and screw stimulation, two monitoring methods used, will not be analyzed correctly and the surgery may be adversely affected. This study compares the results of the 'train of four' test performed by neurophysiologists and anesthesiologists. Additionally, it looks at the differences, if any, in comparing stimulation of the foot nerve (tibial n.) or hand nerve (ulnar n.) Performing the TOF (train of four test) in the lower extremity can be relevant for many reasons. Train of four tests can show the presence of four twitches in the arms but the legs may not fully recovered from muscle relaxant given by anesthesia. Also, train of four test which uses subjective method of interpretation by anesthesiologists may present different results compared than objective quantitative method of train of four test interpretation. Ultimately, the goal of this study is to show the importance of 'TOF' testing in ensuring that any identifiable preventable intraoperative surgical complication is appropriately identified.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

TOF test was performed by two routinely used devices, peripheral nerve stimulator and intraoperative neurophysiologic monitoring device. TOF monitoring of upper extremity included stimulation of ulnar nerve. Negative surface electrode was placed on the wrist in line with the smallest digit 1-2cm below skin crease and the positive 2-3cm proximal to the negative electrode. Active surface recording electrodes were placed on adductor pollicis muscle. TOF monitoring of lower extremity included stimulation of peripheral nerve, posterior tibial nerve. Surface stimulating electrodes were placed, negative over inferolateral aspect of medial malleolus, and positive electrode 2-3cm proximal to the negative electrode. Stimulation current was 20-30 mA for hand and 30-60mA foot TOF by a group of 0.2 millisecond pulses, spaced 500 millisecond apart, to deliver four contractions. Surface recording electrodes were used for measuring muscle response on foot, active electrode which was located on the Flexor hallucis brevis muscle and reference on the big toe. Intraoperative monitoring device was used, and software with TOF monitoring programe was installed. EMG response was calculated by the peak of amplitude (peak to peak amplitude) presented in quantitative value of online measurement. Interpretation was different, visual and subjective. Peripheral nerve stimulator was used for subjective TOF test. Output current was adjustable from 0 to 70 mA. Repeat stimulation of 4 pulses/0.2 milliseconds repeated every 500 milliseconds. Surface negative electrodes were placed over the course of ulnar nerve on the wrist, in line with the smallest digit, 1-2cm proximal from skin crease, and positive electrode 2-3 cm proximal. Response was followed on adductor pollicis muscle. All data were kept in electronic medical records and if data are not complete subjects were not included in the study. Results were compared between TOF methods on two different body sites, upper and lower extremity, by quantitative method and other comparison was made between subjective and quantitative method with TOF test located in both methods on the upper extremity.

Study Type

Observational

Enrollment (Actual)

150

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

    • New York
      • New York, New York, United States, 10003
        • NYU Langone Medical Center, Hospital for Joint Diseases

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

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects undergoing instrumented orthopedic surgical procedure which requires the use of neurophysiologic intraoperative monitoring modalities.

Description

Inclusion Criteria:

Subject undergoing spine fusion surgery when intraoperative neurophysiologic monitoring is included.

Exclusion Criteria:

Subjects with history of previous nerve injury or peripheral neuropathies when intraoperative neurophysiologic monitoring was precluded. Possible technical issues during surgery prior TOF test such as incorrect electrode placement, lead wire attachment, TOF device error or impossibility to correct it in acceptable time when TOF test can not be performed.

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TOF test
TOF - train of four test performed on patiens undergoing lumbar spine surgery where introperative neurophysiologic monitoring is applied. Stimulation of peripheral nerve - ulnar nerve resulting with muscle contractions and evaluation of responses by anesthesiologist and neurophysiologists. Stimulation with group of 0.2 millisecond pulses, spaced 500 millisecond apart, at a 2 Hz rate, current 20-60 mA to deliver four muscle contractions. Eligibility criteria included patients for study where subjective visual interpretation and quantitative interpretation of Adductor pollicis muscle responses is followed.
TOF test includes stimulation of peripheral nerve of upper extremity, ulnar nerve in this study. Two methods of interpretation are included, visual which uses anesthesiologist TOF device, and quantitative uses intraoperative neurophysiologic monitoring device, both devices are in routine clinical practice use. Different interpretation of muscle contractions are followed, by quantitative method and visual method. Visual evaluates number of twitches and determines the degree of neuromuclular block and percent of blocked acetylcholine receptors. Quantitative method record muscle contraction by using EMG, presents each twitch as amplitude, caluculate peak to peak value, and provide numerical value and difference for each twitch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle contraction - TOF twitch after peripheral nerve stimulation
Time Frame: During spine lumbar surgery after pedicle screw placement
TOF test is performed after pedicle screw placement during lumbar spine surgery, prior neurophysiological pedicle screw position test.
During spine lumbar surgery after pedicle screw placement

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Aleksandar Beric, MD, NYU Langone Medical Center

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.

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

April 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

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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