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

Mayo Clinic

Status: Terminated

Conditions: Parotid Gland Disorders

Treatments: Device: Facial Nerve Monitor; Device: APS electrode

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03172520

16-009380

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Facial Nerve Monitoring with APS electrode

Experimental group

Description:

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

Treatment:

Device: APS electrode

Device: Facial Nerve Monitor