Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery

The purpose of this study will explore the advantages of electrodes used for monitoring of the recurrent laryngeal nerve (RLN) in thyroid surgery

Study Overview

• Status: Unknown
• Conditions: Thyroid Surgery; Recurrent Laryngeal Nerve; Electromyographic Monitoring
• Intervention / Treatment: Device: Medtronic Xomed Nerve Integrity Monitor (NIM)

Detailed Description

OBJECTIVES/HYPOTHESIS:

The purpose of this study will explore the advantages and applications of electrodes used for monitoring of the recurrent laryngeal nerve (RLN) in thyroid surgery. We want to know that if the monitoring system will decrease the rate of recurrent laryngeal nerve palsy.

STUDY DESIGN:

One hundred patients who undergoing thyroid surgery will be collected in this study. Patients will be intubated for general anesthesia with a Medtronic Xomed Nerve Integrity Monitor (NIM) EMG endotracheal tube (Jacksonville, Fla) that had 2 electrodes imbedded in the wall of the endotracheal tube. These wires were placed up against each vocal cord. Two grounding wires(needle No. 26) were placed up in the subcutaneous tissues of both shoulders. The electrode wires, grounding wires, and nerve stimulator were connected to a monitoring device (Medtronic NIM-Response) that recoded a visual evoked potential and audible beep to each muscle contraction of a vocal cord. A Medtronic Xomed Prass monopolar nerve stimulator wand was used to test the RLN intraoperatively and was set at 0.5mA. Direct physical touching of the RLN with nerve stimulator using pulsed current would produce an audible "beep-beep-beep".

CONCLUSION:

This study will be conducted in cooperation with Department of anesthesiology. The following subjects will be collected and elucidated:

1. If the muscle relaxant used during surgery will affect the operation of RLN monitoring system.
2. Can RLN monitoring system accurately identify the RLN
3. Can RLN monitoring system accurately predict the function of RLN
4. Can RLN monitoring system decrease the RLN palsy rate after thyroidectomy
5. Application of RLN monitoring to determine the safety and the benefit of vagal stimulation at the beginning and the end of thyroid operation
6. Application of RLN monitoring to determine whether extensive dissection of RLN increases the risk of nerve injury.

At least four papers will be written after this study with the topics as followings:

1. Influence of muscle relaxation on neuromonitoring of the recurrent laryngeal nerve during thyroid surgery
2. Intraoperative neuromonitoring of the recurrent laryngeal nerve during thyroid surgery: Plaudits and pitfalls 3. Vagal stimulation during intraoperative neuromonitoring of the recurrent laryngeal nerve in thyroid operation.

4. Does extensive dissection of recurrent laryngeal nerve during thyroid operation increase the risk of nerve injury? Our experience with the application of intraoperative neuromonitoring

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feng-Yu Chiang, M.D.; Phone Number: 5009 886-7-3121101; Email: kmuent@yahoo.com.tw

Study Locations

• Taiwan
  • Kaohsiung City
    • Kaohsiung, Kaohsiung City, Taiwan, 807
      • Recruiting
      • Department of Otolaryngology- Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan
      • Contact: Feng-Yu Chiang, M.D.; Phone Number: 5009 886-7-3121101; Email: kmuent@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Thyroid disease for operation

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NIM (Nerve Integrity Monitor)

Device: Medtronic Xomed Nerve Integrity Monitor (NIM); patients receive surgery will be intubated with Medtronic Xomed NIM EMG endotracheal tube and the device will be connected to the monitoring system; The channel leads from the NIM EMG reinforced endotracheal tube were connected to a NIM-response monitor; A Prass monopolar probe was used in direct contact with the vagus nerve and RLN for laryngeal nerve stimulation.; The stimuli were generated from the NIM-Response monitor for vagal and RLN stimulation.; The NIM-response monitor was set to run with a 50 millisecond time window and an amplitude scale at 0.2 mV/division. Event capture was activated with a threshold at 100 μV. Peak to peak amplitudes of evoked EMG activities were directly read on the monitor screen.; Other Names: (Medtronic Xomed, Jacksonville, FL).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
If the muscle relaxant used during surgery will affect the operation of RLN monitoring system.	during operation

Secondary Outcome Measures

Outcome Measure	Time Frame
Can RLN monitoring system accurately predict the function of RLN Can RLN monitoring system decrease the RLN palsy rate after thyroidectomy	early postoperation period
Can standardization of IONM procedures further lower the RLN palsy rate	early postoperation period
Dose IONM help to decrease the RLN palsy rate during difficult thyroid operations	early postoperation period

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Study Director: Feng-Yu Chiang, M.D., Department of Otolaryngology- Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan; Principal Investigator: Che-Wei Wu, MD, Department of Otolaryngology- Head and Neck Surgery,Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan

Publications and helpful links

General Publications

• Wu CW, Dionigi G, Chen HC, Chen HY, Lee KW, Lu IC, Chang PY, Hsiao PJ, Ho KY, Chiang FY. Vagal nerve stimulation without dissecting the carotid sheath during intraoperative neuromonitoring of the recurrent laryngeal nerve in thyroid surgery. Head Neck. 2013 Oct;35(10):1443-7. doi: 10.1002/hed.23154. Epub 2012 Sep 18.
• Chiang FY, Lu IC, Tsai CJ, Hsiao PJ, Lee KW, Wu CW. Detecting and identifying nonrecurrent laryngeal nerve with the application of intraoperative neuromonitoring during thyroid and parathyroid operation. Am J Otolaryngol. 2012 Jan-Feb;33(1):1-5. doi: 10.1016/j.amjoto.2010.11.011. Epub 2011 Feb 8.
• Chiang FY, Lu IC, Tsai CJ, Hsiao PJ, Hsu CC, Wu CW. Does extensive dissection of recurrent laryngeal nerve during thyroid operation increase the risk of nerve injury? Evidence from the application of intraoperative neuromonitoring. Am J Otolaryngol. 2011 Nov-Dec;32(6):499-503. doi: 10.1016/j.amjoto.2010.11.001. Epub 2011 Feb 8.
• Chiang FY, Lu IC, Chen HC, Chen HY, Tsai CJ, Lee KW, Hsiao PJ, Wu CW. Intraoperative neuromonitoring for early localization and identification of recurrent laryngeal nerve during thyroid surgery. Kaohsiung J Med Sci. 2010 Dec;26(12):633-9. doi: 10.1016/S1607-551X(10)70097-8.
• Chiang FY, Lu IC, Kuo WR, Lee KW, Chang NC, Wu CW. The mechanism of recurrent laryngeal nerve injury during thyroid surgery--the application of intraoperative neuromonitoring. Surgery. 2008 Jun;143(6):743-9. doi: 10.1016/j.surg.2008.02.006.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: February 26, 2008
• First Submitted That Met QC Criteria: March 5, 2008
• First Posted (Estimate): March 6, 2008

Study Record Updates

• Last Update Posted (Estimate): September 8, 2010
• Last Update Submitted That Met QC Criteria: September 6, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: EMG; Thyroid; RLN
• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Disease Attributes; Recurrence; Thyroid Diseases
• Other Study ID Numbers: KMUH-IRB-EMG-01