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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193943
Recruitment Status : Active, not recruiting
First Posted : December 11, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Elisa Seghelini,MD, 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.

Condition or disease
Critical Illness Polyneuropathy Critical Illness Myopathy

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation Study of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy
Actual Study Start Date : June 18, 2014
Actual Primary Completion Date : November 26, 2014
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Disorders




Primary Outcome Measures :
  1. 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 [ Time Frame: up to the comlpete execution of the two peroneal nerve exams,at most an hour ]
    DTComPair-package in R

  2. 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 [ Time Frame: up to the comlpete execution of the two peroneal nerve exams, at most an hour ]
    DTComPair-package in R


Secondary Outcome Measures :
  1. 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 [ Time Frame: 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

  2. correlation between hospital mortality and abnormal peroneal nerve test [ Time Frame: up to hospital discharge, an average of 6 months ]
    Anova

  3. correlation between hospital discharge destination and abnormal peroneal nerve test [ Time Frame: up to hospital discharge, an average of 6 months ]
    Anova



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Critically Ill Patients
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193943


Locations
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Italy
Spedali Civili
Brescia, Italy, 25123
Sponsors and Collaborators
Università degli Studi di Brescia
Investigators
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Principal Investigator: Elisa Seghelini II Servizio di Anestesia e Rianimazone, Spedali Civili
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Responsible Party: Elisa Seghelini,MD, Principal Investigator, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT04193943    
Other Study ID Numbers: PN 1700/2014
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Diseases
Polyneuropathies
Critical Illness
Disease Attributes
Pathologic Processes
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Peripheral Nervous System Diseases