Electromyography and Acceleromyography in Ventilated ICU Patients

NCT ID: NCT03778749

Last Updated: 2019-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-25

Study Completion Date

2019-05-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neuromuscular Monitoring

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TOF measurements

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type EXPERIMENTAL

TOF measurements

Intervention Type 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

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.

Group Type EXPERIMENTAL

TOF measurements

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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TOF measurements

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Onze Lieve Vrouw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guy CAMMU

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guy Cammu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium

Locations

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OLV Hospital

Aalst, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 28044330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30447682 (View on PubMed)

Other Identifiers

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2018/091

Identifier Type: -

Identifier Source: org_study_id

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