Trial Outcomes & Findings for Automatic Periodic Stimulation and Continuous Electromyography (EMG) for Facial Nerve Monitoring During Parotidectomy (NCT NCT03172520)

Results Overview

EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

baseline, approximately 3 hours

Results posted on

2020-01-18

Participant milestones
Measure	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. 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.
Overall Study STARTED	10
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	10

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Facial Nerve Monitoring With APS Electrode n=10 Participants 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.
Age, Continuous	59.67 years STANDARD_DEVIATION 14.47 • n=10 Participants
Sex: Female, Male Female	2 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants

Timeframe: baseline, approximately 3 hours

Population: Study terminated due to limitations in timing and personnel. Data was not collected

EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Mayo Clinic

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