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

ConditionICU Acquired Weakness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorEndeavor Health

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: HealthyActive comparator 3 interventions
Group B: Critically Ill patientsActive comparator 3 interventions
Group C: Intubated ICU patientsActive comparator 3 interventions

Trial outcomes

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).

Time frame
day 1,5, and 10 of enrollment

Secondary outcomes

1

Longitudinal trend analysis of CMAP amplitudes

Longitudinal trend analysis of CMAP amplitudes and duration across days 1, 5, and 10. In the intubated ICU cohort, we hypothesize that amplitudes will decline over time and CMAP duration will increase.

Time frame
day 1,5,10 of enrollment
2

Hospital length of stay

Duration of ICU stay.

Time frame
From ICU admission through discharge or death, up to 90 days, whichever comes first.
3

Intubation length

Duration of intubation in ICU.

Time frame
From intubation through extubation in ICU or death, up to 90 days, whichever comes first.
4

Reintubation

Incidence of reintubation in the ICU in subjects enrolled.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Endeavor Health

Lead sponsor

Source ClinicalTrials.gov
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