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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03802500
Acronym
EDX
Enrollment
20
Registered
2019-01-14
Start date
2019-01-23
Completion date
2019-12-31
Last updated
2019-10-04

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

Conditions

ICU Acquired Weakness

Brief 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.

Interventions

DIAGNOSTIC_TESTNerve 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.

Sponsors

Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Patients admitted to the ICU with a septic shock and ventilated for more than 72 hours.

Exclusion criteria

* Hospitalization for more than 7 days before intubation. * Functional disability at admission of ≥4 (Requires constant nursing care and attention, bedridden, incontinent) in the Modified Rankin Scale. * Lower limb disorders precluding nerve conduction studies (NCV) and electromyography (EMG), such as clinical edema of the lower limbs, or fractures, amputation, and plaster casts of the lower limbs. * Evidence of altered neuromuscular transmission at repetitive stimulation test either caused by neuromuscular blocking agents or disease. * Burn patients admitted to ICU. * Patient requesting withdrawal of therapies.

Design outcomes

Primary

MeasureTime frameDescription
Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours.72 hoursMedical Research Council strength scale

Secondary

MeasureTime frameDescription
Hospital length of stayUp to 6 months
Discharge destinationAt discharge from hospital, up to 6 months
ICU length of stayUp to 6 months
Extubation failure rateup to 72 hours, after first extubationPatients requiring reintubation 72 hours after failed first extubation
Time elapsed between endotracheal intubation and first out-of-bed mobilizationup to 6 months, at first out-of-bed mobilization
Length of ventilatory supportAt extubation, up to 6 months

Countries

Switzerland

Contacts

Primary ContactCAROLINE ATTWELL
caroline.attwell@chuv.ch0789242320

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026