Can a handheld nerve monitor detect early ICU weakness in healthy people and ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, parallel-cohort pilot compares a handheld neuromuscular monitor with standard EMG/NCS testing in three groups: healthy volunteers, non-intubated ICU patients, and intubated ICU patients. Each cohort includes 8 participants, for a total of 24 from Endeavor Health, with testing conducted on days 1, 5, and 10. The study uses each participant as their own control to observe changes in muscle response signals. EMG/NCS procedures are performed by a neurologist and are for research purposes only, not routine care. Enrollment of ICU patients occurs within 72 hours of ICU admission, and non-ICU participants are followed for up to 90 days post-discharge for outcome data.

Why it matters

Who can join: the full rules

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 it's running

• Endeavor Health
  Evanston, Illinois, United States Recruiting

Study contacts

• Principal investigator: Cliodhna Ashe, MD — Endeavor Health
• Study coordinator: Jessica Brickner
• Email: jessica.brickner@endeavorhealth.org
• Phone: 847-570-1197

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.