Clinical trial NCT03778749: Electromyography and Acceleromyography in Ventilated ICU Patients
Official title: The Effectiveness of Electromyographic- and Acceleromyographic-based Monitors in Diagnosing Pre-existing Train-of-four Fade in Ventilated ICU Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neuromuscular Monitoring
Keywords: train-of-four monitoring
acceleromyography
electromyography
intensive care unit
Lead sponsor: Onze Lieve Vrouw Hospital
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2018-12-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 72 hours of study period in ICU
Secondary outcomes:
measure: fade (TOF% <90) difference between central (corrugator supercilii) and peripheral (adductor pollicis) muscles in ICU patients who require prolonged mechanical ventilation.
timeFrame: 72 hours of study period in ICU
Other outcomes:
measure: optimal monitor for use in the ICU setting
timeFrame: 72 hours of study period in ICU
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital
Study officials:
affiliation: Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium
name: Guy Cammu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738.
citation: Cammu G, Neyens E, Coddens J, Van Praet F, De Decker K. Postoperative residual curarisation is still an issue when weaning patients in intensive care following cardiac surgery. Anaesth Intensive Care. 2018 Nov;46(6):634-636. No abstract available.