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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04193943
Other study ID # PN 1700/2014
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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