← Back to all trials
Recruiting
NCT07699562
ICU CONNECT: Study Comparing EMG in Healthy Volunteers and ICU Patients.
Conditions: ICU Acquired Weakness
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 24
Sponsor: Endeavor Health
Location: Endeavor Health Evanston Illinois
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07699562). StuddyBuddy aggregates publicly available trial information.