NCT00629746

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 8, 2010

Status Verified

May 1, 2010

Enrollment Period

6.5 years

First QC Date

February 26, 2008

Last Update Submit

September 6, 2010

Conditions

Thyroid SurgeryRecurrent Laryngeal NerveElectromyographic Monitoring

Keywords

ThyroidRLNEMG

Outcome Measures

Primary Outcomes (1)

  • If the muscle relaxant used during surgery will affect the operation of RLN monitoring system.

    during operation

Secondary Outcomes (3)

  • 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

Study Arms (1)

NIM (Nerve Integrity Monitor)

EXPERIMENTAL
Device: Medtronic Xomed Nerve Integrity Monitor (NIM)

Interventions

Medtronic Xomed Nerve Integrity Monitor (NIM)DEVICE

patients receive surgery will be intubated with Medtronic Xomed NIM EMG endotracheal tube and the device will be connected to the monitoring system 1. The channel leads from the NIM EMG reinforced endotracheal tube were connected to a NIM-response monitor 2. A Prass monopolar probe was used in direct contact with the vagus nerve and RLN for laryngeal nerve stimulation. 3. The stimuli were generated from the NIM-Response monitor for vagal and RLN stimulation. 4. 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.

Also known as: (Medtronic Xomed, Jacksonville, FL).
NIM (Nerve Integrity Monitor)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Thyroid disease for operation

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology- Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan

Kaohsiung City, Kaohsiung City, 807, Taiwan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22987562DERIVED

  • 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.

    PMID: 21306793DERIVED

  • 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.

    PMID: 21306792DERIVED

  • 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.

    PMID: 21186011DERIVED

  • 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.

    PMID: 18549890DERIVED

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Feng-Yu Chiang, M.D.

    Department of Otolaryngology- Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan

    STUDY DIRECTOR

  • Che-Wei Wu, MD

    Department of Otolaryngology- Head and Neck Surgery,Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng-Yu Chiang, M.D.

CONTACT

886-7-3121101kmuent@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 6, 2008

Study Start

June 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 8, 2010

Record last verified: 2010-05

Locations

TW(1)