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

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.

Study Overview

• Status: Terminated
• Conditions: Neuromuscular Monitoring
• Intervention / Treatment: Diagnostic test: TOF measurements

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • OLV Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: electromyographic NMT monitoring at the hand; 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; The investigators will determine how the TOF% values vary in each individual patient, over time, in ICU.
Experimental: acceleromyographic NMT monitoring at the hand; 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; The investigators will determine how the TOF% values vary in each individual patient, over time, in ICU.
Experimental: acceleromyographic NMT monitoring at the eyebrow; 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; The investigators will determine how the TOF% values vary in each individual patient, over time, in ICU.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
optimal monitor for use in the ICU setting	to determine the TOF% repeatability of the three monitors, establishing the optimal monitor for use in the ICU setting	72 hours of study period in ICU

Collaborators and Investigators

• Sponsor: Onze Lieve Vrouw Hospital
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Guy Cammu, MD,PhD, Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): May 16, 2019
• Study Completion (Actual): May 16, 2019

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: intensive care unit; electromyography; train-of-four monitoring; acceleromyography
• Other Study ID Numbers: 2018/091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No