ICU CONNECT: Comparing TetraGraph and EMG in ICU Patients

This study, called ICU CONNECT, is looking at how well a non-invasive device called TetraGraph can detect early signs of weakness that can happen in the Intensive Care Unit (ICU). It compares the TetraGraph readings with standard nerve and muscle tests (EMG and NCS) done by a specialist. The goal is to see if the TetraGraph can accurately identify these changes. Researchers will measure muscle responses in your hand and leg over about 10 days. The study includes healthy volunteers, ICU patients who are not on breathing machines, and ICU patients who are on breathing machines. The main goal is to see how well the bedside quantitative neuromuscular monitoring (TetraGraph) works at days 1, 5, and 10.

Study design
This is a pilot study comparing three groups of participants: healthy volunteers, non-intubated critically ill patients, and intubated critically ill patients. It plans to enroll 24 participants in total.
What's involved
You would undergo nerve and muscle tests (EMG/NCS and TetraGraph) over about 10 days. If you are an ICU patient, you will be enrolled within the first 72 hours of your ICU stay.
Compensation
Not stated in the trial record.
Follow-up
Healthy volunteers are followed for 10 days after their first visit. ICU patients are followed for 90 days after leaving the hospital.

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NCT07699562

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

Recruiting
NAAges 18–90InterventionalDiagnostic
Endeavor Health
~24 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:TetraGraphElectromyographyNerve conduction studies

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
bedside quantitative neuromuscular monitoring
Measured over day 1,5, and 10 of enrollment
ICU Acquired Weakness
1 sites across 1 states
Illinois1
  • Cliodhna Ashe, MD · PRINCIPAL_INVESTIGATOR · Endeavor Health

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Eligibility criteria

Inclusion

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).
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

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.
  • bedside quantitative neuromuscular monitoringday 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).