NCT07699562 · Endeavor Health
ICU CONNECT: Study Comparing EMG in Healthy Volunteers and ICU Patients.
(ICU CONNECT)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
TetraGraph
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.
DEVICE
Electromyography
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.
DEVICE
Nerve 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.
Primary outcome measures
bedside quantitative neuromuscular monitoring
Time frame: day 1,5, and 10 of enrollment
The primary objective is to assess agreement between bedside quantitative neuromuscular monitoring and standard NCS/EMG for CMAP amplitude and duration at the abductor digiti minimi and tibialis anterior on study days 1,5, and 10 in three cohorts (healthy volunteers, non-intubated ICU patients, and mechanically ventilated ICU patients).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 \< 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 criteria
- Cohort 1: Healthy volunteers Exclusion criteria:
- 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 Exclusion criteria:
- 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 Exclusion criteria:
- 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.
Where
- Evanston, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations