Electromyography and Acceleromyography in Ventilated ICU Patients

Not Applicable

Terminated

• Conditions: Neuromuscular Monitoring
• Interventions: Diagnostic Test: TOF measurements

• Registration Number: NCT03778749
• Lead Sponsor: Onze Lieve Vrouw Hospital

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.

Study Timeline

• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-14
• Study First Posted: 2018-12-19
• Study Start: 2019-01-25
• Status Verified: 2019-05
• Primary Completion: 2019-05-16
• Study Completion: 2019-05-16
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
electromyographic NMT monitoring at the hand	TOF measurements	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.
acceleromyographic NMT monitoring at the eyebrow	TOF measurements	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.
acceleromyographic NMT monitoring at the hand	TOF measurements	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.

Primary Outcome Measures

Name	Time	Method
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 ICU	to find whether any patients show any pre-existing neuromuscular fade or develop such weakness over the 72 hours of study period in ICU

Secondary Outcome Measures

Name	Time	Method
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 ICU	to compare the development of fade (if any develops) between central and peripheral muscles over the 72 hours of study period in ICU

Trial Locations

Locations (1)

OLV Hospital; 🇧🇪 Aalst, Belgium