Clinical Trials Directory

Trials / Unknown

UnknownNCT03802500

Neurophysiological Diagnosis for ICU Septic Shock Patients

Early Electromyographic Evaluation of the ICU-acquired Weakness in Septic Shock Patients Ventilated Longer Than 72 Hours: Neurophysiological Study

Status
Unknown
Phase
Study type
Observational
Enrollment
20 (estimated)
Sponsor
Centre Hospitalier Universitaire Vaudois · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Patients hospitalized in the Intensive Care Unit (ICU) are at risk for developing severe disabilities, physical or cognitive. In particular, ICU-acquired weakness is frequent. The causes of this weakness are multiple and the physiopathology is still not fully understood. Immobilization in bed and sepsis are known risk factors. ICU-acquired weakness has been associated with prolonged mechanical ventilation duration, and increased in ICU and hospital length of stay. It has also been associated with significant decrease in functional capacity and with higher mortality. An early screening using a specific diagnostic protocol could help improving the management of patients suffering from ICU acquired weakness. The aim of this study is to early detect ICU acquired weakness in patients suffering from septic shock and ventilated for more than 72 hours.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTNerve conduction studyPhysical examination of muscle strength is conducted using the Medical Research Council (MRC) scale in 6 muscles bilaterally. Patients with an MRC score of less than 48 of 60 are diagnosed with critical illness polyneuromyopathy (CIPNM). The evaluation is completed by a routine neurological examination. In patients meeting the inclusion criteria, the screening Peroneal nerve test (PENT test) is performed on the day of study enrollment and subsequently in 1 week intervals until pathologic findings are detected or patient is discharged from the ICU. PENT measures the peroneal nerve Compound muscle action potential (CMAP) amplitude in one leg. If the PENT is normal, the contra-lateral peroneal nerve is measured. An abnormal condition is identified if the peroneal nerve CMAP amplitude is reduced below the normal limits of the participating centre in at least one leg. In Lausanne, the abnormal response is \< 2,5 mV.

Timeline

Start date
2019-01-23
Primary completion
2019-10-31
Completion
2019-12-31
First posted
2019-01-14
Last updated
2019-10-04

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03802500. Inclusion in this directory is not an endorsement.