Electromyography and Acceleromyography in Ventilated ICU Patients

NCT03778749 | Terminated

• 1 other identifier: 2018/091
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Monitoring

Keywords

train-of-four monitoring; acceleromyography; electromyography; intensive care unit

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (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

Other Outcomes (1)

• optimal monitor for use in the ICU setting

  72 hours of study period in ICU

Study Arms (3)

electromyographic NMT monitoring at the hand

EXPERIMENTAL

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

acceleromyographic NMT monitoring at the hand

EXPERIMENTAL

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

acceleromyographic NMT monitoring at the eyebrow

EXPERIMENTAL

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

Interventions

TOF measurements DIAGNOSTIC_TEST

The investigators will determine how the TOF% values vary in each individual patient, over time, in ICU.

acceleromyographic NMT monitoring at the eyebrow; acceleromyographic NMT monitoring at the hand; electromyographic NMT monitoring at the hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yr. old or older
• expected to require mechanical ventilation for more than 72 hrs

You may not qualify if:

• degenerative neurological disease
• receive drugs interfering with NMT (e.g., aminoglycosides or magnesium)

Sponsors & Collaborators

• Onze Lieve Vrouw Hospital: lead
• Mayo Clinic: collaborator

Study Sites (1)

OLV Hospital

Aalst, 9300, Belgium

Location

Related Publications (2)

• 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.

  PMID: 28044330 BACKGROUND

• 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.

  PMID: 30447682 BACKGROUND

Study Officials

• Guy Cammu, MD,PhD

  Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 19, 2018
• Study Start: January 25, 2019
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

BE (1)