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Electromyography and Acceleromyography in Ventilated ICU Patients

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03778749
Enrollment
12
Registered
2018-12-19
Start date
2019-01-25
Completion date
2019-05-16
Last updated
2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Monitoring

Keywords

train-of-four monitoring, acceleromyography, electromyography, intensive care unit

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTTOF measurements

The investigators will determine how the TOF% values vary in each individual patient, over time, in ICU.

Sponsors

Mayo Clinic
CollaboratorOTHER
Onze Lieve Vrouw Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
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.72 hours of study period in ICUto find whether any patients show any pre-existing neuromuscular fade or develop such weakness over the 72 hours of study period in ICU

Secondary

MeasureTime frameDescription
fade (TOF% <90) difference between central (corrugator supercilii) and peripheral (adductor pollicis) muscles in ICU patients who require prolonged mechanical ventilation.72 hours of study period in ICUto compare the development of fade (if any develops) between central and peripheral muscles over the 72 hours of study period in ICU

Other

MeasureTime frameDescription
optimal monitor for use in the ICU setting72 hours of study period in ICUto determine the TOF% repeatability of the three monitors, establishing the optimal monitor for use in the ICU setting

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026