Neuromuscular Blockade Monitoring, NMT
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICECollection of NMT Technology
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.
Sponsors
GE Healthcare
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Study subject (male or female) is age 18 years or older (≥18 years). 2. Study subject must have the ability to understand and provide written informed consent. 3. Study subject is undergoing a clinically indicated procedure requiring the use of paralytic medication. 4. Study subject will have the primary NMT monitoring conducted using an NMT ElectroSensor on the hand/forearm.
Exclusion criteria
1. Are known to be pregnant. 2. Are breastfeeding. 3. Suffering from an infection(s) that requires isolation. 4. Deformity, scar tissue, tattoos, or other characteristics at the sensor application area that could interfere (e.g., nerve damage) with the completion of the study procedure or identify a study subject. 5. Subjects requiring rapid sequence induction 6. Subjects expected to be at risk from participation for any reason, such as those with known allergy or sensitivity to adhesive materials that may be used in the study. 7. Direct employees or contractors of GE HealthCare, or any company that makes NMT monitoring devices (sensors, cables, modules). 8. NMT ElectroSensor placed on the foot/ankle
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of End User Feedback Surveys | Up to 24 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collection of raw parameter data from NMT Sensor and Cable | Up to 24 hours | Collection of raw parameter data from NMT Sensor and Cable to evaluate the reliability of the measurements to NMBA concordance rate. |
| Incidence of Safety Events | 4 months. | 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. |
Countries
United States
Contacts
CONTACTMelissa McCabe, MD
Outcome results
None listed