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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 26, 2008 | ||||||||
| Last Updated Date | August 30, 2009 | ||||||||
| Start Date ICMJE | June 2006 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
If the muscle relaxant used during surgery will affect the operation of RLN monitoring system. [ Time Frame: during operation ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00629746 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery | ||||||||
| Official Title ICMJE | Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery | ||||||||
| 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 |
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| 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:
At least two papers will be written after this study with the topics as followings:
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Device: Medtronic Xomed Nerve Integrity Monitor (NIM) | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00629746 | ||||||||
| Responsible Party | Feng-Yu Chiang, MD, Department of Otolaryngology, Kaohsiung Medical University, Taiwan. | ||||||||
| Study ID Numbers ICMJE | KMUH-IRB-EMG-01 | ||||||||
| Study Sponsor ICMJE | Kaohsiung Medical University Chung-Ho Memorial Hospital | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Kaohsiung Medical University Chung-Ho Memorial Hospital | ||||||||
| Verification Date | August 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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