Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00629746
First received: February 26, 2008
Last updated: September 6, 2010
Last verified: May 2010
  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

Resource links provided by NLM:


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 ]

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 ]
  • Can standardization of IONM procedures further lower the RLN palsy rate [ Time Frame: early postoperation period ] [ Designated as safety issue: No ]
  • Dose IONM help to decrease the RLN palsy rate during difficult thyroid operations [ Time Frame: early postoperation period ] [ Designated as safety issue: No ]

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

  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.
Other Name: (Medtronic Xomed, Jacksonville, FL).

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
  5. Application of RLN monitoring to determine the safety and the benefit of vagal stimulation at the beginning and the end of thyroid operation
  6. 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:

  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 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Thyroid disease for operation

Exclusion Criteria:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Principal Investigator: Che-Wei Wu, MD Department of Otolaryngology- Head and Neck Surgery,Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan
  More Information

No publications provided by Kaohsiung Medical University Chung-Ho Memorial Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

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

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 29, 2014