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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04193943

Acronym

CRIMINE-3

Enrollment

130

Registered

2019-12-11

Start date

2014-06-18

Completion date

2020-05-01

Last updated

2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness Myopathy, Critical Illness Polyneuropathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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
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

Measure	Time frame	Description
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
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

Countries

Italy

Outcome results