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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-12-30

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.

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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.

Conditions

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Parotid Gland Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Facial Nerve Monitoring with APS electrode

The investigators will use the Facial Nerve Monitor along with the automatic periodic stimulating(APS) electrode during parotidectomy surgery.

Group Type EXPERIMENTAL

APS electrode

Intervention Type DEVICE

The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.

Facial Nerve Monitor

Intervention Type DEVICE

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.

Interventions

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APS electrode

The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.

Intervention Type DEVICE

Facial Nerve Monitor

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.

Intervention Type DEVICE

Other Intervention Names

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automatic periodic stimulating (APS) Electrode Stimulator NIM-Response 3.0

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No