Electromyography and Acceleromyography in Ventilated ICU Patients

Neuromuscular Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03778749
• Other study ID #: 2018/091
• Status: Terminated
• Phase: N/A
• Start date: January 25, 2019
• Est. completion date: May 16, 2019

Study information

• Verified date: May 2019
• Source: Onze Lieve Vrouw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: May 16, 2019
• Est. primary completion date: May 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neuromuscular Monitoring

Intervention

Diagnostic Test:
• TOF measurements
The investigators will determine how the TOF% values vary in each individual patient, over time, in ICU.

Locations

Country	Name	City	State
Belgium	OLV Hospital	Aalst

Sponsors (2)

Lead Sponsor	Collaborator
Onze Lieve Vrouw Hospital	Mayo Clinic

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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