Neurophysiological Diagnosis for ICU Septic Shock Patients (EDX)
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|ClinicalTrials.gov Identifier: NCT03802500|
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : October 4, 2019
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.
|Condition or disease||Intervention/treatment|
|ICU Acquired Weakness||Diagnostic Test: Nerve conduction study|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Early Electromyographic Evaluation of the ICU-acquired Weakness in Septic Shock Patients Ventilated Longer Than 72 Hours: Neurophysiological Study|
|Actual Study Start Date :||January 23, 2019|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- Diagnostic Test: Nerve conduction study
Physical 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.Other Name: Peroneal nerve test (PENT test)
- Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours. [ Time Frame: 72 hours ]Medical Research Council strength scale
- ICU length of stay [ Time Frame: Up to 6 months ]
- Hospital length of stay [ Time Frame: Up to 6 months ]
- Discharge destination [ Time Frame: At discharge from hospital, up to 6 months ]
- Length of ventilatory support [ Time Frame: At extubation, up to 6 months ]
- Extubation failure rate [ Time Frame: up to 72 hours, after first extubation ]Patients requiring reintubation 72 hours after failed first extubation
- Time elapsed between endotracheal intubation and first out-of-bed mobilization [ Time Frame: up to 6 months, at first out-of-bed mobilization ]
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): NCT03802500
|Contact: CAROLINE ATTWELLemail@example.com|
|Lausanne, Vaud, Switzerland, 1000|
|Contact: CAROLINE ATTWELL 0795567994 firstname.lastname@example.org|
|Study Director:||Karin Diserens, PD-MER||NRA Unit. CHUV.|