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Clinical Trials/NCT03778749
NCT03778749
Terminated
Not Applicable

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

Onze Lieve Vrouw Hospital1 site in 1 country12 target enrollmentJanuary 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuromuscular Monitoring
Sponsor
Onze Lieve Vrouw Hospital
Enrollment
12
Locations
1
Primary Endpoint
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.
Status
Terminated
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 25, 2019
End Date
May 16, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Onze Lieve Vrouw Hospital
Responsible Party
Principal Investigator
Principal Investigator

Guy CAMMU

Principal Investigator

Onze Lieve Vrouw Hospital

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)

Outcomes

Primary Outcomes

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.

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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