Electromyography and Acceleromyography in Ventilated ICU Patients

Onze Lieve Vrouw Hospital

Status: Terminated

Conditions: Neuromuscular Monitoring

Treatments: Diagnostic Test: TOF measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT03778749

2018/091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 3 patient groups

electromyographic NMT monitoring at the hand

Experimental group

Description:

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.

Treatment:

Diagnostic Test: TOF measurements

acceleromyographic NMT monitoring at the hand

Experimental group

Description:

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.

Treatment:

Diagnostic Test: TOF measurements

acceleromyographic NMT monitoring at the eyebrow

Experimental group

Description:

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.

Treatment:

Diagnostic Test: TOF measurements