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

NCT07699562 | Recruiting DMC FDA Device

• 1 other identifier: IRB2026-0068
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ICU Acquired Weakness

Outcome Measures

Primary Outcomes (1)

• bedside quantitative neuromuscular monitoring

  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).

  day 1,5, and 10 of enrollment

Secondary Outcomes (12)

• Longitudinal trend analysis of CMAP amplitudes

  day 1,5,10 of enrollment

• Hospital length of stay

  From ICU admission through discharge or death, up to 90 days, whichever comes first.

• Intubation length

  From intubation through extubation in ICU or death, up to 90 days, whichever comes first.

• Reintubation

  From ICU admission through discharge or death, up to 90 days, whichever comes first.

• Electrolyte levels

  From hospital admission through discharge or death, up to 90 days, whichever comes first.

Study Arms (3)

Healthy

ACTIVE COMPARATOR

Healthy volunteers will be recruited primarily through flyers placed in Endeavor Health hospitals and surrounding communities. They will undergo NCS, EMG, and Tetragraph testing on days 1,5,10

Device: TetraGraph; Device: Electromyography; Device: Nerve conduction studies

Critically Ill patients

ACTIVE COMPARATOR

Critically ill, non-intubated patients in an Endeavor Health ICU. They will undergo NCS, EMG, and Tetragraph testing on days 1,5,10

Device: TetraGraph; Device: Electromyography; Device: Nerve conduction studies

Intubated ICU patients

ACTIVE COMPARATOR

ICU patients that are intubated within the first 72 hours of their ICU stay as our preliminary data suggested the CMAP amplitudes started to drop after this time. they will undergo NCS, EMG, and Tetragraph testing on days 1,5,10

Device: TetraGraph; Device: Electromyography; Device: Nerve conduction studies

Interventions

TetraGraph DEVICE

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.

Critically Ill patients; Healthy; Intubated ICU patients

Electromyography DEVICE

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.

Critically Ill patients; Healthy; Intubated ICU patients

Nerve conduction studies DEVICE

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.

Critically Ill patients; Healthy; Intubated ICU patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Endeavor Health

Evanston, Illinois, 60201, United States

RECRUITING

MeSH Terms

Interventions

Electromyography; Nerve Conduction Studies

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography; Diagnostic Techniques, Neurological

Study Officials

• Cliodhna Ashe, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Brickner

CONTACT

847-570-1197; jessica.brickner@endeavorhealth.org

Nia Moragne

CONTACT

847-570-1197; nia.moragne@endeavorhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clincial Professor

Model Details: Prospective, parallel cohort validation trial

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 13, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)