Electromyography and Acceleromyography in Ventilated ICU Patients

• Sponsor: Onze Lieve Vrouw Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03778749
• Collaborator: Mayo Clinic (Other)
• Enrollment: 12
• Location: 1
• Arms: 3
• Actual Duration (Months): 3.6
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Monitoring	Diagnostic Test: TOF measurements	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Effectiveness of Electromyographic- and Acceleromyographic-based Monitors in Diagnosing Pre-existing Train-of-four Fade in Ventilated ICU Patients
• Actual Study Start Date: Jan 25, 2019
• Actual Primary Completion Date: May 16, 2019
• Actual Study Completion Date: May 16, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Other Outcome Measures

1. optimal monitor for use in the ICU setting [72 hours of study period in ICU]

   to determine the TOF% repeatability of the three monitors, establishing the optimal monitor for use in the ICU setting

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OLV Hospital	Aalst		Belgium	9300

Sponsors and Collaborators

• Onze Lieve Vrouw Hospital
• Mayo Clinic

Investigators

• Principal Investigator: Guy Cammu, MD,PhD, Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Guy CAMMU, Principal Investigator, Onze Lieve Vrouw Hospital
• ClinicalTrials.gov Identifier: NCT03778749
• Other Study ID Numbers: 2018/091
• First Posted: Dec 19, 2018
• Last Update Posted: May 21, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Guy CAMMU, Principal Investigator, Onze Lieve Vrouw Hospital: train-of-four monitoring; acceleromyography; electromyography; intensive care unit

Study Results

No Results Posted as of May 21, 2019