Automatic Periodic Stimulation and Continuous Electromyography (EMG) for Facial Nerve Monitoring During Parotidectomy
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/24/2018 |
| Start Date: | May 1, 2018 |
| End Date: | June 30, 2018 |
| Contact: | Daniel B Noel, M.D. |
| Email: | Noel.Daniel@mayo.edu |
| Phone: | 507-284-2453 |
Use of Automatic Periodic Stimulation and Continuous EMG for Facial Nerve Monitoring During Parotidectomy
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.
stimulating (APS) Electrode Stimulator during a parotidectomy and potentially prevent
post-operative facial nerve weakness, which is a relatively common outcome after parotid
surgery.
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.
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.
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
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Phone: 507-284-2453
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