Electromyography and Acceleromyography in Ventilated ICU Patients

Study Overview
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Brief Summary
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In intensive care unit (ICU) patients who are mechanically ventilated for a longer period of time, there might be a difference in accuracy and performance of neuromuscular transmission monitoring [as measured by the train-of-four (TOF)%] due to a pre-existing TOF fade, correlated to some form of acquired muscle weakness. The investigators therefore propose to search for and compare the optimal monitoring techniques (acceleromyography vs. electromyography) and the optimal muscle monitoring site (peripheral-adductor pollicis vs. central-corrugator supercilii) in ICU patients who require prolonged mechanical ventilation.

Detailed Description
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The following neuromuscular transmission monitors will be used in the study: an electromyography-based monitor (TetraGraph, Senzime AB, Uppsala, Sweden) and two devices that are the newer generation of quantitative monitoring using three-dimensional acceleromyographic technology: Stimpod (Xavant Technology, Pretoria, South Africa) and TofScan (IDmed, Marseilles, France), both of which require minimal setup for use. The stimulation pattern of both ulnar and facial nerves will be train-of-four (TOF) delivered every 1 minute, and the mean of three consecutive measurements will be calculated as the TOF% for that patient. Patients will be tested every 24 hrs, once a day, at the same time, over the 72 hrs the study will take place in the ICU.

Official Title
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The Effectiveness of Electromyographic- and Acceleromyographic-based Monitors in Diagnosing Pre-existing Train-of-four Fade in Ventilated ICU Patients

Conditions
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Neuromuscular Monitoring

Intervention / Treatment
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* Diagnostic Test: TOF measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 yr. old or older expected to require mechanical ventilation for more than 72 hrs Exclusion Criteria: degenerative neurological disease receive drugs interfering with NMT (e.g., aminoglycosides or magnesium)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Twenty mechanically ventilated ICU patients: the investigators will compare the mean TOF% between three different measurement techniques in 20 mechanically ventilated ICU patients: 1/electromyographic neuromuscular transmission monitoring at the hand muscle - 2/acceleromyographic neuromuscular transmission monitoring at the hand muscle - 3/acceleromyographic neuromuscular transmission monitoring at the eyebrow muscle; and the investigators will determine how the three TOF% values vary in each individual patient.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electromyographic NMT monitoring at the hand<br>In 20 mechanically ventilated ICU patients, TOF measurements will be performed every 24 hrs, once a day, at the same time, over the 72 hrs the study will take place in the ICU. | Diagnostic Test: TOF measurements<br>* The investigators will determine how the TOF% values vary in each individual patient, over time, in ICU.<br>|
| Experimental: acceleromyographic NMT monitoring at the hand<br>In 20 mechanically ventilated ICU patients, TOF measurements will be performed every 24 hrs, once a day, at the same time, over the 72 hrs the study will take place in the ICU. | Diagnostic Test: TOF measurements<br>* The investigators will determine how the TOF% values vary in each individual patient, over time, in ICU.<br>|
| Experimental: acceleromyographic NMT monitoring at the eyebrow<br>In 20 mechanically ventilated ICU patients, TOF measurements will be performed every 24 hrs, once a day, at the same time, over the 72 hrs the study will take place in the ICU. | Diagnostic Test: TOF measurements<br>* The investigators will determine how the TOF% values vary in each individual patient, over time, in ICU.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-existing neuromuscular fade (TOF% <90), correlated to some form of ICU acquired muscle weakness, in ICU patients mechanically ventilated for more than 72 hrs. | to find whether any patients show any pre-existing neuromuscular fade or develop such weakness over the 72 hours of study period in ICU | 72 hours of study period in ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fade (TOF% <90) difference between central (corrugator supercilii) and peripheral (adductor pollicis) muscles in ICU patients who require prolonged mechanical ventilation. | to compare the development of fade (if any develops) between central and peripheral muscles over the 72 hours of study period in ICU | 72 hours of study period in ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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train-of-four monitoring, acceleromyography, electromyography, intensive care unit