ICU CONNECT Trial: A MultIcenter Comparison Cohort Trial EvalUating the Correlation Between nOn-iNvasive EMG and iNvasive EMG in Healthy Volunteers and Critically Ill PaTients
Endeavor Health
Summary
This study is testing whether a non-invasive nerve monitoring device (TetraGraph) can accurately detect early signs of ICU-acquired weakness by comparing readings from the device with standard nerve conduction/EMG tests done by a specialist to see if they match. They will focus on muscle response signals in the hand and leg over about 10 days in three groups: healthy volunteers, ICU patients who are not on ventilators, and ICU patients who are on ventilators.
Description
This is a prospective, parallel-cohort controlled pilot trial involving adults who are either 1) healthy volunteers, 2) non-intubated critically ill Endeavor Health ICU patients, or 3) intubated critically ill Endeavor Health ICU patients. Each cohort will have 8 total participants for a total of 24 patients from Endeavor Health. The testing done in this study (EMG/NCS and TetraGraph) is not part of standard of care procedures for critically ill patients. These tests are being performed for research purposes only. Participants in cohorts 2 and 3 (non-intubated ICU patients and intubated ICU p…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Cohort 1: Healthy volunteers Inclusion criteria: * Subjects must be \> 18 years old and \< 90 years old. * Subjects must consent to participate. Cohort 2: Non-intubated critically ill patients Inclusion criteria: * Subjects may be male or female. * Subjects must be \> 18 years old and \< 90 years old. * Subjects must have a POA or next of kin who is able to consent (for those in the ICU and who are unable to consent themselves). Cohort 3: Intubated critically ill patients Inclusion criteria: * Subjects may be male or female. * Subjects must be \> 18 years old and…
Interventions
- DeviceTetraGraph
The TetraGraph is a non-invasive surface nerve conduction study (NCS) device, currently FDA-approved for monitoring perioperative neuromuscular blockade depth. The device delivers brief (0.2 msec) electrical stimuli to the patient's hand (abductor digiti minimi) or lower leg (tibialis anterior) to monitor the compound action potential.
- DeviceElectromyography
Electromyography (EMG) is an FDA-approved diagnostic procedure that involves inserting a needle electrode into muscle tissue to record its electrical activity. In this study, EMG findings will primarily be performed to rule out other causes of weakness and to help confirm the suspected diagnosis of CIP and/or CIM.
- DeviceNerve conduction studies
Nerve conduction studies (NCS) are FDA-approved diagnostic tests that use surface electrodes to stimulate peripheral nerves and assess nerve function. In this study, NCS findings will be compared to handheld quantitative neuromuscular monitor measurements.
Location
- Endeavor HealthEvanston, Illinois