Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery
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|ClinicalTrials.gov Identifier: NCT00629746|
Recruitment Status : Unknown
Verified May 2010 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was: Recruiting
First Posted : March 6, 2008
Last Update Posted : September 8, 2010
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Surgery Recurrent Laryngeal Nerve Electromyographic Monitoring||Device: Medtronic Xomed Nerve Integrity Monitor (NIM)||Not Applicable|
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.
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".
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery|
|Study Start Date :||June 2006|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
|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
Other Name: (Medtronic Xomed, Jacksonville, FL).
- If the muscle relaxant used during surgery will affect the operation of RLN monitoring system. [ Time Frame: during operation ]
- 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 ]
- Can standardization of IONM procedures further lower the RLN palsy rate [ Time Frame: early postoperation period ]
- Dose IONM help to decrease the RLN palsy rate during difficult thyroid operations [ Time Frame: early postoperation period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629746
|Contact: Feng-Yu Chiang, M.D.||886-7-3121101 ext firstname.lastname@example.org|
|Department of Otolaryngology- Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan||Recruiting|
|Kaohsiung, Kaohsiung City, Taiwan, 807|
|Contact: Feng-Yu Chiang, M.D. 886-7-3121101 ext 5009 email@example.com|
|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|