RecruitingNot ApplicableNCT07699562

ICU CONNECT: Study Comparing EMG in Healthy Volunteers and ICU Patients.

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

Sponsor

Endeavor Health

Enrollment

24 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

ICU acquired weakness

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria12

Cohort 1: Healthy volunteers
Subjects must be > 18 years old and < 90 years old.
Subjects must consent to participate. Cohort 2: Non-intubated critically ill patients
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
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).
For the Subjects in the ICU that are intubated, they must be planned to be intubated for at least 24 hours.
Subjects must be intubated for no longer than ≥ 72 hours before enrollment.

Exclusion Criteria16

Cohort 1: Healthy volunteers
Subjects with previous paralysis or neuromuscular disease.
Subjects with spinal cord or brain injuries that impact motor function.
Subjects with an allergy to clinical adhesive or hydrogel. Cohort 2: Non-intubated critically ill patients
Subjects with previous paralysis or neuromuscular diseases.
Subjects with previous peripheral nerve injuries to the tested limbs.
Subjects with spinal cord or brain injuries (including stroke) that impact motor function.
Subjects without a POA or next of kin for those patients that are unable to consent themselves.
Subjects with an allergy to clinical adhesive or hydrogel. Cohort 3: Intubated critically ill patients
Subjects with previous paralysis or neuromuscular disease
Subjects with previous peripheral nerve injuries to the tested limbs.
Subjects with spinal cord or brain injuries that impact motor function.
Subjects without a POA or next of kin for those patients that are in the intubated arm.
Subjects with intubations expected to last less than 24 hours.
Subjects who have already been intubated for > 72 hours.
Subjects with an allergy to clinical adhesive or hydrogel.

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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.