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| Sponsor: | Kaohsiung Medical University Chung-Ho Memorial Hospital |
|---|---|
| Information provided by: | Kaohsiung Medical University Chung-Ho Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00629746 |
Purpose
The purpose of this study will explore the advantages of electrodes used for monitoring of the recurrent laryngeal nerve (RLN) in thyroid surgery
| Condition | Intervention |
|---|---|
|
Thyroid Surgery Recurrent Laryngeal Nerve Electromyographic Monitoring |
Device: Medtronic Xomed Nerve Integrity Monitor (NIM) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery |
| Estimated Enrollment: | 1000 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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).
|
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:
At least four papers will be written after this study with the topics as followings:
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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Feng-Yu Chiang, M.D. | 886-7-3121101 ext 5009 | kmuent@yahoo.com.tw |
| Taiwan | |
| 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 kmuent@yahoo.com.tw | |
| 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 |
More Information
| Responsible Party: | Feng-Yu Chiang, MD, Department of Otolaryngology, Kaohsiung Medical University, Taiwan. |
| ClinicalTrials.gov Identifier: | NCT00629746 History of Changes |
| Other Study ID Numbers: | KMUH-IRB-EMG-01 |
| Study First Received: | February 26, 2008 |
| Last Updated: | September 6, 2010 |
| Health Authority: | Taiwan: Institutional Review Board |
|
Thyroid RLN EMG |
|
Thyroid Diseases Endocrine System Diseases |