Validation of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy (CRIMINE-3)

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

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness Myopathy; Critical Illness Polyneuropathy

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25123
    • Spedali Civili

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically Ill Patients

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
correlation between hospital mortality and abnormal peroneal nerve test	Anova	up to hospital discharge, an average of 6 months
correlation between hospital discharge destination and abnormal peroneal nerve test	Anova	up to hospital discharge, an average of 6 months

Collaborators and Investigators

• Sponsor: Università degli Studi di Brescia
• Investigators: Principal Investigator: Elisa Seghelini, II Servizio di Anestesia e Rianimazone, Spedali Civili

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2014
• Primary Completion (ACTUAL): November 26, 2014
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: December 8, 2019
• First Posted (ACTUAL): December 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease Attributes; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Critical Illness; Polyneuropathies; Muscular Diseases
• Other Study ID Numbers: PN 1700/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No