NMT EasyFit Sensor and Cable

Purpose

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.

Conditions

  • Neuromuscular Blockade Monitoring
  • NMT

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
All Subjects 		Placement of NMT Sensor on Hand and Forearm
  • Device: Collection 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.

Recruiting Locations

Loma Linda University Health
Loma Linda, California 92354
Contact:
Melissa McCabe
909-558-4256
mmcabe@llu.edu

More Details

Status
Recruiting
Sponsor
GE Healthcare

Study Contact

Melissa McCabe, MD
909-558-4475
mmccabe@llu.edu

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).