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Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery

This study is currently recruiting participants.
Verified by Kaohsiung Medical University Chung-Ho Memorial Hospital, December 2007

Sponsored by: 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 NIM EMG endotracheal tube & monitor

ChemIDplus related topics:   Thyroid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • If the muscle relaxant used during surgery will affect the operation of RLN monitoring system. [ Time Frame: during operation ] [ Designated as safety issue: No ]
  • Can RLN monitoring system accurately identify the RLN [ Time Frame: during operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   200
Study Start Date:   June 2006
Estimated Study Completion Date:   July 2008
Estimated Primary Completion Date:   July 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator Device: Medtronic Xomed NIM EMG endotracheal tube & monitor
patients receive surgery will be intubated with Medtronic Xomed NIM EMG endotracheal tube and the device will be connected to the monitoring system

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:

  1. If the muscle relaxant used during surgery will affect the operation of RLN monitoring system.
  2. Can RLN monitoring system accurately identify the RLN
  3. Can RLN monitoring system accurately predict the function of RLN
  4. Can RLN monitoring system decrease the RLN palsy rate after thyroidectomy

At least two papers will be written after this study with the topics as followings:

  1. Influence of muscle relaxation on neuromonitoring of the recurrent laryngeal nerve during thyroid surgery
  2. Intraoperative neuromonitoring of the recurrent laryngeal nerve during thyroid surgery: Plaudits and pitfalls
  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Thyroid disease for operation

Exclusion Criteria:

  • N/A
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629746

Contacts
Contact: Feng-Yu Chiang, M.D.     886-7-3121101 ext 5009     kmuent@yahoo.com.tw    

Locations
Taiwan, Kaohsiung City
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    

Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators
Study Director:     Feng-Yu Chiang, M.D.     Department of Otolaryngology- Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan    
  More Information

Publications indexed to this study:

Responsible Party:   Department of Otolaryngology, Kaohsiung Medical University, Taiwan. ( Feng-Yu Chiang, MD )
Study ID Numbers:   KMUH-IRB-EMG-01
First Received:   February 26, 2008
Last Updated:   March 5, 2008
ClinicalTrials.gov Identifier:   NCT00629746
Health Authority:   Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Thyroid  
RLN  
EMG  

Study placed in the following topic categories:
Recurrence

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2008




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