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

• Conditions: Critical Illness Polyneuropathy; Critical Illness Myopathy

• Registration Number: NCT04193943
• Lead Sponsor: Università degli Studi di Brescia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-18
• Primary Completion: 2014-11-26
• Study First Submitted: 2019-11-25
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-08
• Last Update Submitted: 2019-12-10
• Study First Posted: 2019-12-11
• Last Update Posted: 2019-12-13
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	up to the comlpete execution of the two peroneal nerve exams, at most an hour	DTComPair-package in R
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	up to the comlpete execution of the two peroneal nerve exams,at most an hour	DTComPair-package in R

Secondary Outcome Measures

Name	Time	Method
correlation between hospital mortality and abnormal peroneal nerve test	up to hospital discharge, an average of 6 months	Anova
correlation between hospital discharge destination and abnormal peroneal nerve test	up to hospital discharge, an average of 6 months	Anova
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	up to the comlpete execution of the two peroneal nerve exams, at most an hour	It will be performed either using Bland-Altman plot and mix model effect

Trial Locations

Locations (1)

Spedali Civili; 🇮🇹 Brescia, Italy