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| Name | Class |
|---|---|
| Loma Linda University | OTHER |
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The purpose of this clinical study is to collect and assess feedback from clinical users regarding the functionality and device use and collection of raw parameter date from the NMT Sensor and NMT Cable.
The NMT Sensor provides quantitative, automated measurements of neuromuscular block by delivering non-invasive electrical stimuli to the ulnar nerve and recording electromyography (EMG) responses from the adductor pollicis muscle. Surface hydrogel electrodes with adhesive foam ensure secure placement for continuous monitoring. The single-use sensor connects to a reusable NMT Cable and is designed for use with GE HealthCare NMT measurement devices (NMT Module and bedside monitors).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | Experimental | Placement of NMT Sensor on Hand and Forearm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of NMT Technology | Device | Collection and assessment of non-invasive electrical stimuli from the NMT measurement placed on the patient's hand and forearm to measure the level of neuromuscular blocking agents during standard of care surgical procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of End User Feedback Surveys | Collection of end user feedback surveys on the functionality and clinical use of the NMT Sensor and Cable during standard of care surgical procedure (minimum of 1 hour and maximum of 24 hours). | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of raw parameter data from NMT Sensor and Cable | Collection of raw parameter data from NMT Sensor and Cable to evaluate the reliability of the measurements to NMBA concordance rate. | Up to 24 hours |
| Incidence of Safety Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa McCabe, MD | Contact | 909-558-4475 | mmccabe@llu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health | Recruiting | Loma Linda | California | 92354 | United States |
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Analysis of adverse events will be listed per subject, summarized with counts and percentages of events, and summarized with counts and percentages of subjects with events.
| 4 months. |