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

NCT03893058 | Unknown

• 1 other identifier: NP2963
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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. 1.To estimate the prevalence of NMJ disorders acquired during critical illnesses using SF-EMG.
2. 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.

Conditions

Critical Illness Polyneuropathy; Critical Illness Myopathy; Weakness Due to Disease; Neuromuscular Blockade

Keywords

Train-Of-Four; Single Fiber Electromyography; NeuroMuscular Junction; Critical Illness

Outcome Measures

Primary Outcomes (2)

• Prevalence of NeuroMuscularJunction disorders acquired during critical illnesses.

  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.

  3 years

• Reliability (specificity and sensitivity) of Train-Of-Four in critically ill patients.

  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.

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

ASST Spedali Civili di Brescia

Brescia, 25124, Italy

Location

Related Publications (26)

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MeSH Terms

Conditions

Polyneuropathies; Critical Illness

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: February 12, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

IT (1)