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Evaluation of the NeuroMuscular Junction Using the Single Fiber Electromyography and Reliability of Train-Of-Four in Critically Ill Patients.

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ClinicalTrials.gov Identifier: NCT03893058
Recruitment Status : Active, not recruiting
First Posted : March 28, 2019
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Matteo Filippini, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief Summary:

Patients suffering from critical illnesses who are admitted to the Intensive Care Unit (ICU) are often affected by multiple organ failure. Among those dysfunctions, it is very important to mention the neuromuscular system failure, known as Intensive Care Unit-Acquired Weakness (ICU-AW). In non-cooperative patients, the simplified electromyography (called Peroneal Nerve Test, PENT) allows diagnosing the Critical Illness Polyneuropathy (CIP) and/or the Critical Illness Myopathy (CIM), which are two causes of ICU-AW. The ICU-AW can involve both nerves and muscles, but so far there has been no evidence about the involvement of the third element of the neuromuscular system: the neuromuscular junction (NMJ). The gold standard technique to study the function of the NMJ is the Desmedt test, a particular type of Electroneurography (ENG); the Single Fiber Electromyography (SF-EMG ) might be a valid and more sensitive technique for this analysis. The spreading use of Neuromuscular Blocking Agents (NMBAs) has led to the introduction of the Train-Of-Four acceleromyography (TOF) monitoring in ICU; however, there is a lack of information on its reliability in critically ill patients.

Some conditions related to critical illness, like the ICU-AW, could make TOF monitoring unreliable.

The aims of the study are:

  1. To estimate the prevalence of NMJ disorders acquired during critical illnesses using SF-EMG.
  2. To assess the reliability of TOF in critically ill patients. The study will evaluate patients with critical illnesses hospitalised in the General Intensive Care Unit (UOC Anestesia e Rianimazione 2, Spedali Civili di Brescia). To diagnose CIP and/or CIM, PENT will be performed after 72 hours from the admission in the ICU and every 72 hours. To evaluate NMJ disorders, SF-EMG will be performed in patients with an abnormal PENT. To evaluate the reliability of TOF, the test will be performed before, during and after NMBAs treatment and in all studied patients, independently from NMBAs administration; the presence of neuromuscular blockade will be evaluated clinically and/or using instrumental tests like Desmedt test. Statistical analysis will be performed to represent the prevalence of NMJ disorders in the general intensivistic population and the reliability of TOF in terms of specificity and sensitivity for the diagnosis of the neuromuscular blockade.

Condition or disease
Critical Illness Polyneuropathy Critical Illness Myopathy Weakness Due to Disease Neuromuscular Blockade

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Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the NeuroMuscular Junction Using the Single Fiber Electromyography and Reliability of Train-Of-Four in Critically Ill Patients.
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber




Primary Outcome Measures :
  1. Prevalence of NeuroMuscularJunction disorders acquired during critical illnesses. [ Time Frame: 3 years ]
    The prevalence will be assessed as the proportion of patients found to be affected by NMJ disorders (assessed by SFEMG) among the population of critically ill patients.

  2. Reliability (specificity and sensitivity) of Train-Of-Four in critically ill patients. [ Time Frame: 3 years ]

    The sensitivity of TOF for the diagnosis of the neuromuscular blockade will be expressed as the proportion of patients with the neuromuscular blockade and with abnormal TOF ratio (<90%) among patients with the neuromuscular blockade and with normal or abnormal TOF ratio.

    The specificity of TOF for the diagnosis of the neuromuscular blockade will be expressed as the proportion of patients without the neuromuscular blockade and with normal TOF ratio (>90%) among patients without neuromuscular blockade and with normal or abnormal TOF ratio.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with critical illnesses hospitalised in the General Intensive Care Unit (UOC Anestesia e Rianimazione 2, Spedali Civili di Brescia)
Criteria

Inclusion Criteria:

Adult patients (18-year-old and older ones) hospitalised in ICU. In order to realise the first aim of the study (to estimate the prevalence of NMJ disorders acquired during critical illnesses using SF-EMG), patients with a pathologic PENT will be evaluated. In order to realise the second aim of the study (to assess the reliability of TOF in critically ill patients. The study will evaluate patients with critical illnesses hospitalised in the General Intensive Care Unit), patients who receive NMBAs will be evaluated; patients who do not receive NMBAs will also be evaluated, as a control group.

Exclusion Criteria:

  • patients with a terminal disease;
  • patients with an ICU-length-of-staying perspective less than 72 hours;
  • patients with a chronic disease associated with known neuropathy or myopathy;
  • patients treated with drugs that may cause neurotoxicity and myotoxicity;
  • patients with primary or secondary acute Peripheral Nervous System (PNS) lesions or muscle lesions;
  • patients with prosthesis, wounds or other conditions that prevent electrophysiological testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893058


Locations
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Italy
ASST Spedali Civili di Brescia
Brescia, Italy, 25124
Sponsors and Collaborators
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Publications:

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Responsible Party: Matteo Filippini, Principal Investigator, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT03893058    
Other Study ID Numbers: NP2963
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matteo Filippini, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia:
Train-Of-Four
Single Fiber Electromyography
NeuroMuscular Junction
Critical Illness
Additional relevant MeSH terms:
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Polyneuropathies
Critical Illness
Disease Attributes
Pathologic Processes
Neuromuscular Diseases
Nervous System Diseases
Peripheral Nervous System Diseases