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

NCT04193943 | Unknown

• 1 other identifier: PN 1700/2014
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness Polyneuropathy; Critical Illness Myopathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• correlation between hospital mortality and abnormal peroneal nerve test

  up to hospital discharge, an average of 6 months

• correlation between hospital discharge destination and abnormal peroneal nerve test

  up to hospital discharge, an average of 6 months

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

Critically Ill Patients

You may qualify if:

• \- adult patients admitted to Intensive care unit

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Study Sites (1)

Spedali Civili

Brescia, 25123, Italy

Location

MeSH Terms

Conditions

Polyneuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Elisa Seghelini

  II Servizio di Anestesia e Rianimazone, Spedali Civili

  PRINCIPAL INVESTIGATOR

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: November 25, 2019
• First Posted: December 11, 2019
• Study Start: June 18, 2014
• Primary Completion: November 26, 2014
• Study Completion: May 1, 2020
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)