Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery
Primary Purpose
Thyroid Surgery, Recurrent Laryngeal Nerve, Electromyographic Monitoring
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Medtronic Xomed Nerve Integrity Monitor (NIM)
Sponsored by
About this trial
This is an interventional prevention trial for Thyroid Surgery focused on measuring Thyroid, RLN, EMG
Eligibility Criteria
Inclusion Criteria:
- Thyroid disease for operation
Exclusion Criteria:
- N/A
Sites / Locations
- Department of Otolaryngology- Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, TaiwanRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NIM (Nerve Integrity Monitor)
Arm Description
Outcomes
Primary Outcome Measures
If the muscle relaxant used during surgery will affect the operation of RLN monitoring system.
Secondary Outcome Measures
Can RLN monitoring system accurately predict the function of RLN Can RLN monitoring system decrease the RLN palsy rate after thyroidectomy
Can standardization of IONM procedures further lower the RLN palsy rate
Dose IONM help to decrease the RLN palsy rate during difficult thyroid operations
Full Information
NCT ID
NCT00629746
First Posted
February 26, 2008
Last Updated
September 6, 2010
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00629746
Brief Title
Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery
Official Title
Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study will explore the advantages of electrodes used for monitoring of the recurrent laryngeal nerve (RLN) in thyroid surgery
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:
If the muscle relaxant used during surgery will affect the operation of RLN monitoring system.
Can RLN monitoring system accurately identify the RLN
Can RLN monitoring system accurately predict the function of RLN
Can RLN monitoring system decrease the RLN palsy rate after thyroidectomy
Application of RLN monitoring to determine the safety and the benefit of vagal stimulation at the beginning and the end of thyroid operation
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:
Influence of muscle relaxation on neuromonitoring of the recurrent laryngeal nerve during thyroid surgery
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Surgery, Recurrent Laryngeal Nerve, Electromyographic Monitoring
Keywords
Thyroid, RLN, EMG
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NIM (Nerve Integrity Monitor)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Medtronic Xomed Nerve Integrity Monitor (NIM)
Other Intervention Name(s)
(Medtronic Xomed, Jacksonville, FL).
Intervention Description
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.
Primary Outcome Measure Information:
Title
If the muscle relaxant used during surgery will affect the operation of RLN monitoring system.
Time Frame
during operation
Secondary Outcome Measure Information:
Title
Can RLN monitoring system accurately predict the function of RLN Can RLN monitoring system decrease the RLN palsy rate after thyroidectomy
Time Frame
early postoperation period
Title
Can standardization of IONM procedures further lower the RLN palsy rate
Time Frame
early postoperation period
Title
Dose IONM help to decrease the RLN palsy rate during difficult thyroid operations
Time Frame
early postoperation period
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Thyroid disease for operation
Exclusion Criteria:
N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng-Yu Chiang, M.D.
Phone
886-7-3121101
Ext
5009
Email
kmuent@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng-Yu Chiang, M.D.
Organizational Affiliation
Department of Otolaryngology- Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Che-Wei Wu, MD
Organizational Affiliation
Department of Otolaryngology- Head and Neck Surgery,Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology- Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan
City
Kaohsiung
State/Province
Kaohsiung City
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng-Yu Chiang, M.D.
Phone
886-7-3121101
Ext
5009
Email
kmuent@yahoo.com.tw
12. IPD Sharing Statement
Citations:
PubMed Identifier
22987562
Citation
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.
Results Reference
derived
PubMed Identifier
21306793
Citation
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.
Results Reference
derived
PubMed Identifier
21306792
Citation
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.
Results Reference
derived
PubMed Identifier
21186011
Citation
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.
Results Reference
derived
PubMed Identifier
18549890
Citation
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.
Results Reference
derived
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Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery
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