Parotid Gland Disorders
Conditions
Keywords
Parotidectomy
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.
Interventions
DEVICEAPS electrode
The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.
DEVICEFacial 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.
Sponsors
Medtronic
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Facial Nerve Monitoring With APS Electrode The investigators will use the Facial Nerve Monitor along with the APS electrode during parotidectomy surgery.
APS electrode: 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: 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Facial Nerve Monitoring With APS Electrode | — |
|---|---|---|
| Age, Continuous | 59.67 years STANDARD_DEVIATION 14.47 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Change in Electromyography (EMG)
EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.
Time frame: baseline, approximately 3 hours
Population: Study terminated due to limitations in timing and personnel. Data was not collected