Automatic Periodic Stimulation and Continuous Electromyography (EMG) for Facial Nerve Monitoring During Parotidectomy

Study Overview
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Brief Summary
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The purpose of this study is to document the safety of the Medtronic automatic periodic stimulating (APS) Electrode Stimulator during a parotidectomy and potentially prevent post-operative facial nerve weakness, which is a relatively common outcome after parotid surgery.

Detailed Description
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This study will be conducted in two phases. In the first phase the investigators will use the same monitoring system currently used during parotidectomy and requires placement of the APS electrode as the only additional piece of equipment. During this phase, the investigators will record intraoperative EMG data generated by the monitoring system as well as document intra-operative maneuvers that precede adverse EMG events. In the second phase of the study the investigators aim to allow the surgeon to alter his or her techniques, with the information provided by the APS electrode, to reverse adverse EMG changes.

Official Title
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Use of Automatic Periodic Stimulation and Continuous EMG for Facial Nerve Monitoring During Parotidectomy

Conditions
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Parotid Gland Disorders

Intervention / Treatment
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* Device: APS electrode
* Device: Facial Nerve Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parotidectomy: Planned parotid gland surgery (superficial or total parotidectomy) Benign or malignant disease Exclusion Criteria: Current pregnancy Preoperative facial nerve dysfunction Revision surgery History of preoperative radiation to the surgical field Retrograde or extracapsular dissection Intentional nerve sacrifice (i.e., due to nerve involvement by tumor) Tumors with proximity to main trunk of facial nerve Inability to place electrode Presence of electrode alters surgical technique

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facial Nerve Monitoring with APS electrode<br>The investigators will use the Facial Nerve Monitor along with the automatic periodic stimulating(APS) electrode during parotidectomy surgery. | Device: APS electrode<br>* The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.<br>* Other names: automatic periodic stimulating (APS) Electrode Stimulator;Device: Facial Nerve Monitor<br>* The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete.<br>* Other names: NIM-Response 3.0;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Electromyography (EMG) | EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles. | baseline, approximately 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parotidectomy