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

Not Applicable

Terminated

• Conditions: Parotid Gland Disorders
• Interventions: Device: APS electrode; Device: Facial Nerve Monitor

• Registration Number: NCT03172520
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-06-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-12-30
• Results First Submitted: 2019-05-30
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-14
• Last Update Submitted: 2020-01-14
• Results First Posted: 2020-01-18
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Electromyography (EMG)	baseline, approximately 3 hours	EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States