Validation of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy

Critical Illness Myopathy Clinical Trial

— CRIMINE-3  

Official title:

Validation Study of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04193943
• Other study ID #: PN 1700/2014
• Status: Active, not recruiting
• Start date: June 18, 2014
• Est. completion date: May 1, 2020

Study information

• Verified date: December 2019
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluate the accuracy, in the diagnosis of critical illness myopathy and / or neuropathy, of the simplified peroneal nerve test performed by a neurophysiopathology technician or by a neurophysiopathology doctor (as the gold standard) compared to the exam performed by an intensivist.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: May 1, 2020
• Est. primary completion date: November 26, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients admitted to Intensive care unit

Exclusion Criteria:

• patients in terminal conditions

• patients with peroneal nerve exam not feasible ( for example with presence of prostheses, wounds, plaster casts, edema of the limbs)

Related Conditions & MeSH terms

• Critical Illness
• Critical Illness Myopathy
• Critical Illness Polyneuropathy
• Muscular Diseases
• Polyneuropathies

Locations

Country	Name	City	State
Italy	Spedali Civili	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity and specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal	DTComPair-package in R	up to the comlpete execution of the two peroneal nerve exams,at most an hour
Primary	specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal	DTComPair-package in R	up to the comlpete execution of the two peroneal nerve exams, at most an hour
Secondary	evaluation of concordance between peroneal nerve test performed by an intensivist compared to peroneal nerve test performed by a neurophysiopathologist considering the test as a continuous variable	It will be performed either using Bland-Altman plot and mix model effect	up to the comlpete execution of the two peroneal nerve exams, at most an hour
Secondary	correlation between hospital mortality and abnormal peroneal nerve test	Anova	up to hospital discharge, an average of 6 months
Secondary	correlation between hospital discharge destination and abnormal peroneal nerve test	Anova	up to hospital discharge, an average of 6 months