An interventional study of EPAD monitoring system in Surgery, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care
Participants to be enrolled in this study will have been scheduled to have laparoscopic genitourinary surgery and EPAD monitoring as part of their clinical care intraoperatively. Patients scheduled for genitourinary surgery are often at risk for developing nerve injuries due to intraoperative positioning.
Somatosensory evoked potential devices (SSEP) are commonly used to detect pending injury to peripheral nerves. The purpose of the present study is to use SSEP monitoring to determine the incidence and potential causes of significant changes in SSEP waveforms and correlate these changes with neurologic status of the brachial plexus after robotic surgery.
Exclusion Criteria:
All participants will be monitored with EPAD system
Device: EPAD monitoring system
EPAD system will be used as part of routine care
Somatosensory Evoked Potential Monitoring
Recording of somatosensory evoked potential in patients undergoing genitourinary surgery
Time frame: in the first 24 hours of postoperative period
| Milestone | Observation |
|---|---|
| Started | 21 |
| Completed | 0 |
| Not completed | 21 |
Recording of somatosensory evoked potential in patients undergoing genitourinary surgery
No measurements were reported for this outcome.
Collected over Adverse Events were collected over a 24 hour period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Observation | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Continuous(years) | Observation |
|---|---|
| Mean | 63 ± 11 |
| Sex: Female, Male(Participants) | Observation |
|---|---|
| Female | 7 |
| Male | 14 |
| Race (NIH/OMB)(Participants) | Observation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Observation |
|---|---|
| United States | 21 |
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