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
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:
- To estimate the prevalence of NMJ disorders acquired during critical illnesses using SF-EMG.
- 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|
|Study Type :||Observational|
|Estimated Enrollment :||85 participants|
|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|
- 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.
- 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.
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
|ASST Spedali Civili di Brescia|
|Brescia, Italy, 25124|