NMT EasyFit Sensor and Cable
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collection of NMT Technology.
- Who it may be relevant to
- Registry conditions: Neuromuscular Blockade Monitoring, NMT. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluate Functionality and Use of the NMT EasyFit Sensor and NMT EasyFit Cable
Overview
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
- 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.
Primary outcome measures
- Collection of End User Feedback Surveys [Time frame: Up to 24 hours]
Secondary outcome measures (2)
- Collection of raw parameter data from NMT Sensor and Cable [Time frame: Up to 24 hours]
- Incidence of Safety Events [Time frame: 4 months.]
Eligibility criteria
Inclusion criteria
- Study subject (male or female) is age 18 years or older (≥18 years).
- Study subject must have the ability to understand and provide written informed consent.
- Study subject is undergoing a clinically indicated procedure requiring the use of paralytic medication.
- Study subject will have the primary NMT monitoring conducted using an NMT ElectroSensor on the hand/forearm.
Exclusion criteria
- Are known to be pregnant.
- Are breastfeeding.
- Suffering from an infection(s) that requires isolation.
- 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.
- Subjects requiring rapid sequence induction
- 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.
- Direct employees or contractors of GE HealthCare, or any company that makes NMT monitoring devices (sensors, cables, modules).
- NMT ElectroSensor placed on the foot/ankle
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- Loma Linda University Health — Loma Linda
Identifiers
NCT: NCT07394140 · SA-000175